COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51254

Dr Ravindra Mittal

kevinkumarkansagra@zyduscadila.com

2021-01-12

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1.Healthy subject of either gender â?¥12 years of age. <br/ >2. Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study. <br/ >3. Ability to provide informed consent from the adult subjects or from the parents of paediatric <br/ >subjects. Additionally, assent from paediatric subjects (Audio video recording in case of <br/ >vulnerable subject). <br/ >4. Adult subjects or parents of paediatric subjects literate enough to fill the diary card. <br/ >5. Subjects with good health or with stable medical condition for chronic disease. (Stable <br/ >condition is defined as there is no change in the medication or dose of medication or severity <br/ >of disease from last 3 months before enrolment.) <br/ >6. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical <br/ >sterilization), from screening until completion of the follow-up visit and males will agree to <br/ >use contraception. <br/ >7. Willing to allow storage and future use of biological samples for future research. <br/ >

1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 <br/ >weeks of enrolment. <br/ >2. Laboratory confirmed SARS-CoV-2 positive. <br/ >3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days. <br/ >4. History of SARS/ MERS infection. <br/ >5. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine. <br/ >6. Past history of hypersensitivity reaction or any serious adverse event after any vaccination. <br/ >7. Past history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation <br/ >therapy. <br/ >8. Subjects with confirmed immunosuppressive or immunodeficiency disorder, or subjects on <br/ >any immunosuppressive or immunostimulant therapy. <br/ >9. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, <br/ >gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological <br/ >disorder. <br/ >10. Subjects administered blood, blood containing products or immunoglobulins within the last <br/ >3 months or planned administration during the study. <br/ >11. Any other vaccine administration within the last 30 days or planned to be administered <br/ >during the study period. <br/ >12. Pregnant and lactating women. <br/ >13. Participation in another clinical trial in the past 3 months. <br/ >14. History of drug / alcohol abuse.

2

Cadila Healthcare Ltd

12

100

India

Healthy volunteers

N/A

28216

To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo.Timepoint: Day 84 to Day 364

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "0,2ml;3;day0-28-56;IM", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "0,2ml;3;day0-28-56;IM", "treatment_id": 1400, "treatment_name": "Zycov-d", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}]