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

Recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/07/026668
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

1. **Title of the project:**: **“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 trialâ€.**

**Objectives:**

**Primary:**

1.    To evaluate efficacy of BCG vaccine as an adjunct to standard prevention practices in reducing the incidence of COVID-19 in the high-risk individuals.

**Secondary:**

1.    To evaluate efficacy of BCG vaccine as an adjunct to standard prevention practices in reducing the incidence of severe COVID-19 in the high-risk individuals.

**Summary:**

**Background:**

On December 2019 the first case of coronavirus disease 2019 (COVID-19) was reported in Wuhan, China’s Hubei province, during an outbreak of viral pneumonia. Some epidemiological studies have proposed universal policies of BCG vaccination may have reduced the number of reported COVID-19 cases in a country. This makes a combined strategy of universal BCG vaccination and combination of healthcare safety may reduce morbidity and mortality. However, the association between vaccine-induced cell-mediated immunity and protection against COVID-19 is unclear.

**Novelty:**

As the previous studies suggest high-risk population which include adults with comorbidities (like hypertension, cardiovascular diseases, cerebrovascular diseases, diabetes, chronic lung disease, and chronic kidney diseases, chronic liver diseases, and malignancy) are at higher risk of SARS-CoV-2 infection. BCG vaccine effectively induces T-helper 1 (Th1) that secrete high levels of IFN-γ and that are active against intracellular pathogens. Recently described, a memory phenotype in innate immune cells, known as “trained immunityâ€. BCG vaccine induces “trained immunity†thus, providing may provide non-specific protection against respiratory infections.

**Methods:**

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|**Study Type:**

**Interventional (Clinical Trial)**

|**Estimated Enrolments:**

**800 (from all sites)**

|**Allocation:**

**Randomized**

|**Intervention Model:**

**Parallel Assignment**

|**Intervention Model Description:**

**Phase III, two group, multicentric, Quadruple blind**

**Randomized controlled trial**

|**Masking:**

**Quadruple** **blind**

**Randomized controlled trial**

|**Primary Purpose:**

**Prevention**

**Study End points:**

**a Primary end point:**

1.    Reduction in incidence of COVID-19

**b Secondary end point:**

1.    Reduction in incidence of severe pneumonia and ARDS related to COVID-19

2.    Reduction in incidence of hospital admission and intensive care admission related to COVID-19

3.    To see the safety of BCG vaccine for prevention and incidence of COVID-19

**\*\*\* COVID-19 case defined as** per Revised Guidelines on Clinical Management of COVID-19 by Ministry of Health & Family Welfare Directorate General of Health Services (EMR Division)

**Keywords:**

**COVID-19, Bacillus Calmette-Guerin (BCG) vaccine, Prevention, and randomized controlled trial**

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-08
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 800

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

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 oHuman immunodeficiency virus (HIV-1), oNeutropenic with less than 1500 neutrophils/mm3, oSolid organ or bone marrow transplantation, oChemotherapy or radiotherapy, and oPrimary immunodeficiency vii.Subject on immunosuppressed or taking immunosuppressive drugs viii.Documented history of COVID-19 infection ix.Active malignancy within the prior two years oActive skin disease such as eczema, dermatitis or psoriasis at or near site of vaccination oDirect involvement in the design or the execution of the study oNot willing to give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of COVID-19 by 9 months of follow-up.	Incidence of COVID-19 by 9 months of follow-up.

Secondary Outcome Measures

Name	Time	Method
1.Incidence of severe COVID-19 by 9 months of follow-up.	2.Incidence of Adverse events following immunization (AEFIs) associated with BCG vaccine.

Trial Locations

Locations (3)

AIIMS, New Delhi; 🇮🇳 Delhi, DELHI, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI), Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

School of Tropical Medicine, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

AIIMS, New Delhi

🇮🇳Delhi, DELHI, India

Dr Sanjeev Sinha

Principal investigator

9810164416

drsanjeevsinha@gmail.com