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To study the effect of BCG vaccine in Reducing the Incidence and severity of COVID-19 in the high-risk population

To evaluate efficacy of Bacillus Calmette-Guerin (BCG) in Reducing the Incidence and severity of COVID-19 in the high-risk population (BRIC): a phase III, Multicentric, Quadruple blind Randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026668
Enrollment
800
Registered
2020-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Conventional BCG vaccine: Standard COVID-19 preventive practices along with BCG Vaccine. Participants will receive a single dose of BCG vaccine at base line. The adult dose of BCG vacci

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. Incidence of severe COVID-19 by 9 months of follow-up. 2. Incidence of Adverse events following immunization (AEFIs) associated with BCG vaccine. 3. The change of titers of PPD-specific IgM and IgG following BCG vaccination Timepoint: 9 months—

Countries

India

Contacts

Public ContactDr Sanjeev Sinha

All India Institute of Medical Science

drsanjeevsinha@gmail.com9810164416

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 13, 2026