COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45677

Dr Sanjeev Sinha

drsanjeevsinha@gmail.com

2020-07-18

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

I. High-risk groups which include: adults (Male and female â?¥18 to 60 years) with underlying medical conditions, particularly if not well controlled, including: <br/ >1. Diabetes mellitus <br/ >2. Chronic kidney disease (both dialysis dependent and independent) <br/ >3. Chronic heart conditions (coronary artery disease and hypertension) <br/ >4. Chronic lung disease (included asthma, COPD and bronchiectasis) <br/ >

i. History of allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration <br/ >ii. Any signs or symptoms of COVID-19 within the past 24 hours <br/ >iii. Pregnancy or planning pregnancy <br/ >iv. Breastfeeding <br/ >v. Suspicion of active viral or bacterial infection <br/ >vi. Any Immunocompromised subjects including <br/ >o Human immunodeficiency virus (HIV-1), <br/ >o Neutropenic with less than 1500 neutrophils/mm3, <br/ >o Solid organ or bone marrow transplantation, <br/ >o Chemotherapy or radiotherapy, and <br/ >o Primary immunodeficiency <br/ >vii. Subject on immunosuppressed or taking immunosuppressive drugs <br/ >viii. Documented history of COVID-19 infection <br/ >ix. Active malignancy within the prior two years <br/ >o Active skin disease such as eczema, dermatitis or psoriasis at or near site of vaccination <br/ >o Direct involvement in the design or the execution of the study <br/ >o Not willing to give consent <br/ >

2

Indian Council of Medical Research

18

60

India

High risk patients

N/A

800

Incidence of COVID-19 by 9 months of follow-up.Timepoint: Incidence of COVID-19 by 9 months of follow-up.

| 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"}]