COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42972

Dr Umesh Shaligram

drhjs@seruminstitute.com

2020-04-21

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Male or Female subjects â?¥ 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection <br/ >2. Test negative for SARS-CoV-2 infection (RT-PCR test) at screening <br/ >3. Capable of giving informed consent

1. Previous history of Tuberculosis or known active Mycobacterium tuberculosis infection <br/ >2. Received BCG vaccine within one year prior to screening <br/ >3. Fever (greater than or equal to 38 ºC/100.4°F) or any other respiratory symptoms/illnesses within the past 14 days <br/ >4. Pregnant or lactating women <br/ >5. Women of child-bearing potential not agreeing to use adequate contraception <br/ >6. Current active viral or bacterial infection <br/ >7. Expected vaccination during the study period, independently of the type of vaccination <br/ >8. Severely immunocompromised subjects. <br/ >9. Active solid or non-solid malignancy or lymphoma within the prior two years <br/ >10. Individuals known to be hypersensitive to any component of the vaccine <br/ >11. Eczema or other significant skin lesion or infection at the site/s of injection. <br/ >12. Any other medical condition which in the opinion of the investigator may affect the subjectâ??s safety or study participation and conduct <br/ >

2

Serum Institute of India Pvt Ltd

18

99

India

Healthy volunteers

N/A

5946

1.Number of subjects with laboratory confirmed COVID-19 infection among HCWs <br/ >2.Number of subjects with laboratory confirmed COVID-19 infection among other high-risk subjects <br/ >3.Number of laboratory confirmed COVID-19 infection with severe; critical or life-threatening disease as assessed by Investigator among HCWs <br/ >4.Number of laboratory confirmed COVID-19 infection with severe; critical or life-threatening disease as assessed by Investigator among other high-risk subjectsTimepoint: up to 6 months (180 days) following vaccine administration

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

Phase 3

[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]