COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53226

Dr Jayesh Sanmukhani

jayeshsanmukhani@zyduscadila.com

2021-03-16

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Healthy subject of either gender 18 to 60 years of age <br/ >2. Informed consent from the subjects (Audio video recording in case of vulnerable subject) <br/ >3. Adult subjects literate enough to fill the diary card <br/ >4. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the follow-up visit and males who agree to use contraception <br/ >

1. Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2. History or laboratory evidence of confirmed SARS-CoV-2 positive <br/ >3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test / RTPCR positive at the time of screening <br/ >5. History of SARS/ MERS infection <br/ >6. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7. Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ >8. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy <br/ >9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder <br/ >11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study <br/ >12. Any other vaccine administration within the last 30 days or planned to be administered during the study period <br/ >13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) <br/ >14. Participation in another clinical trial in the past 3 months <br/ >15. History of drug / alcohol abuse <br/ >

2

Cadila Healthcare Limited

18

60

India

Healthy volunteers

N/A

150

Adverse events (solicited; unsolicited and SAEs) reported during the study in the two groups <br/ > <br/ >Seroconversion rate based on IgG antibodies against S1 antigen (by ELISA) at Day 56. <br/ >Timepoint: Day 56

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

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "3mg;2days0-28", "treatment_id": 1400, "treatment_name": "Zycov-d", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}]