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CTRI Number  CTRI/2020/07/026668 [Registered on: 18/07/2020] Trial Registered Prospectively
Last Modified On: 03/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of BCG vaccine in Reducing the Incidence and severity of COVID-19 in the high-risk population  
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjeev Sinha 
Designation  Professor of Medicine 
Affiliation  All India Institute of Medical Sciences 
Address  Third floor, RN 17, SRB wing, Department of Medicine, Ansari Nagar, AIIMS, New Delhi
E-61. Ansari Nagar East AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India 
Phone  9810164416  
Fax  011-26588918  
Email  drsanjeevsinha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Sinha 
Designation  Professor of Medicine 
Affiliation  All India Institute of Medical Science 
Address  Third floor, RN 17, SRB wing, Department of Medicine, Ansari Nagar, AIIMS, New Delhi
E-61, Ansari Nagar East, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India 
Phone  9810164416  
Fax  011-26588918  
Email  drsanjeevsinha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjeev Sinha 
Designation  Professor of Medicine 
Affiliation  All India Institute Of Medical Science 
Address  Third floor, RN 17, SRB wing, Department of Medicine, Ansari Nagar, AIIMS, New Delhi
E-61, Ansari Nagar, East, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India 
Phone  9810164416  
Fax  011-26588918  
Email  drsanjeevsinha@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, Ansari Nagar, P.Box No. 4911 New Delhi – 110029  
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, P.Box No. 4911 New Delhi – 110029  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjeev Sinha  AIIMS, New Delhi  Room number 17, SRB wing, third floor, Department of Medicine, AIIMS, New Delhi-110029
New Delhi
DELHI 		 9810164416
011-26588918
drsanjeevsinha@gmail.com 
Dr Sushil Gupta  Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI), Lucknow   Second floor, Department of Endocrinology, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI), Rai Bareli Road, Lucknow
Lucknow
UTTAR PRADESH 		 0522-2494395
0522-2668017
sushilguptasgpgi@gmail.com 
Dr SK Guha  School of Tropical Medicine, Kolkata  Second floor, Department of Tropical Medicine, School of Tropical Medicine, 108, Chittaranjan Avenue, Kolkata, West Bengal- 700073
Kolkata
WEST BENGAL 		 9831234802
9831234802
drskguha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Clinical Research Ethics Committee (CREC-STM) Calcutta School of Tropical Medicine  Approved 
Ethics Committee, AIIMS  Approved 
SGPGI Lucknow  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle in left arm.We will follow them for 9 months.  
Comparator Agent  Standard COVID-19 preventive practices along with Inj Placebo (saline). Participants will receive a single dose will consist of 0.1 mL saline at baseline.   The adult dose of BCG vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle in left arm.We will follow them for 9 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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)
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of COVID-19 by 9 months of follow-up.  Incidence of COVID-19 by 9 months of follow-up. 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 9 months 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
  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 trial”.

 

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 immunity”. BCG vaccine induces “trained immunity” thus, providing may provide non-specific protection against respiratory infections.

Methods:

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

 
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