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CTRI Number  CTRI/2020/06/025854 [Registered on: 13/06/2020] Trial Registered Prospectively
Last Modified On: 08/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   BCG vaccination against COVID-19  
Scientific Title of Study   Study to Evaluate the Effectiveness of BCG vaccine in Reducing Morbidity and Mortality in Elderly individuals in COVID-19 Hotspots in India 
Trial Acronym  BCG for COVID-19 
Secondary IDs if Any  
Secondary ID  Identifier 
Version 3.2, 17/05/2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  C Padmapriyadarsini 
Designation  Scientist F 
Affiliation  ICMR-National Institute for Research in Tuberculosis 
Address  Department of Clinical Research ICMR-National Institute for Research in Tuberculosis No.1, Satyamoorthy Road Chetput, Chennai

Chennai
TAMIL NADU
600031
India 
Phone  9498022949  
Fax  044-28362528  
Email  pcorchids@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  C Padmapriyadarsini 
Designation  Scientist F 
Affiliation  ICMR-National Institute for Research in Tuberculosis 
Address  Department of Clinical Research ICMR-National Institute for Research in Tuberculosis, No.1, Satyamoorthy Road Chetput, Chennai

Chennai
TAMIL NADU
600031
India 
Phone  9498022949  
Fax  044-28362528  
Email  pcorchids@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Srikanth Tripathy 
Designation  Director & Scientist G 
Affiliation  ICMR-National Institute for Research in Tuberculosis 
Address  ICMR-National Institute for Research in Tuberculosis No.1, Satyamoorthy Road Chetput, Chennai

Chennai
TAMIL NADU
600031
India 
Phone  28369500  
Fax  044-28362528  
Email  srikanthtripathy@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi 110029 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAnant Mohan  All India Institute of Medical Science, New Delhi  Department of Pulmonary, Critical Care & Sleep Medicine, All India Institute of Medical Sciences,Ansari Nagar, New Delhi, Delhi 110029
New Delhi
DELHI 
09810048204

anantmohan@yahoo.com 
Dr Rujuta Hadaye  GS medical College & KEM Hospital  Professor, Department of Community Medicine, Seth GSMC and KEM Hospital, Kacharya Donde Marg, Parel, Mumbai, Maharashtra 400012
Mumbai (Suburban)
MAHARASHTRA 
09869352260

rujutahadaye@gmail.com 
DrToteja  ICMR-National Institute for Implementation Research on Non-Communicable Disease, Jodhpur  207, 2nd Flr, Sonal Apt Paota-b Rd Paota, Jodhpur, Rajasthan 342006
Jodhpur
RAJASTHAN 
09868368075

gstoteja@gmail.com 
DrRRTiwari  ICMR-National Institute for Research in Environmental Health  Director ICMR-National Institute for Research in Environmental Health Bhauri Bypass Rd, Bhopal - 460066
Bhopal
MADHYA PRADESH 
09225224605

tiwari.rr@gov.in 
DrCPadmapriyadarsini  ICMR-National Institute for Research in Tuberculosis  Room No. 5, Department of Clinical Research, No.1, Mayor Sathyamoorthy Road Chetput, Chennai
Chennai
TAMIL NADU 
044-28369539

pcorchids@gmail.com 
DrAsha Keetharam  ICMR-National Institute of Occupational Health  Department of clinical epidemiology ICMR-National Institute of Occupational Health, Meghani Nagar, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT 
08197080581

ashaketharam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
All India Institute of Medical Science, New Delhi  Submittted/Under Review 
ICMR-National Institute for Implementation Research on Non-Communicable Disease, Jodhpur  Submittted/Under Review 
ICMR-National Institute for Research in Environmental Health, Bhopal  Submittted/Under Review 
ICMR-National Institute of Occupational Health, Ahmedabad  Submittted/Under Review 
KEM Hospital, Mumbai Municipal Corporation of Greater Mumbai  Submittted/Under Review 
National Institute for Research in Tuberculosis, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  COVID-19 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BCG vaccine   Single dose of 0.1ml of BCG vaccine given intradermally (BCG-Serum Institute of India) over the distal insertion of the deltoid muscle onto the left humerus (approximately one third down the left upper arm) Frequency : Once Duration of therpay: Once 
Comparator Agent  None  No intervention 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1)Elderly individuals 60 years – 95 years of age with general good health, as confirmed by history and physical examination.

2) No known history of HIV or on immunosuppressive drugs for malignancy or transplant

3) Provide a signed and dated informed consent form

Elderly individuals with or without co-morbid conditions like Diabetes mellitus, or Hypertension or Hyperlipidemia will be considered for this study, if they are on regular treatment.  
 
ExclusionCriteria 
Details  1) Positive for SARS-Cov2 infection, by either antibody (serology) or PCR test
2) Known HIV or malignancy or Transplant recipient or on Dialysis
3) Individuals on immune-suppressive therapies or treatments for malignancy or transplant / dialysis / anti-retroviral treatment
4) Recently (in the last 6-months) diagnosed with TB or currently on anti-TB treatment or anti-psychiatric medications
5) Has any BCG vaccine contraindication like allergy or hypersensitivity to BCG, individuals with HIV infection, leukaemia, malignant lymphoma, chronic granulomatous disease,
6) H/o of previous administration of experimental MTB vaccines within the past 6 months.
7) Sick and moribund individuals with Karnofsky score <50
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with Severe COVID disease based on COVID Severity Scale and proportion of death due to Covid 19 disease
 
6 months post vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of Hospital admission and ICU admission due to Covid-19
2. Proportion of participants in various Severity stages of Covid-19 (mild, moderate or severe)
3. Proportion of participants requiring hospital admission due to other respiratory febrile illness
4. Immunological outcomes in the sub study
 
At 6 months post vaccination 
 
Target Sample Size   Total Sample Size="1450"
Sample Size from India="1450" 
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)   25/06/2020 
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="0"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Brief Summary  

1. Rationale: SARS-CoV2 viral infection is spreading rapidly throughout the world. A large epidemic in India poses a major threat to the public health system. Elderly individuals, especially those with diabetes, hypertension and other chronic diseases are especially at high risk of mortality. Strategies to protect these individuals are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in-vitro and in-vivo studies, and reported significant reductions in morbidity and mortality. Based on the capacity of BCG to reduce the incidence of respiratory tract infections in children and adults, to exert antiviral effects in experimental models; and to reduce viremia in an experimental human model of viral infection, the hypothesis is that BCG vaccination will partially protect against mortality in high-risk, elderly individuals.

 

2. Primary objective: To evaluate the effectiveness of BCG vaccination in preventing morbidity and mortality due to COVID-19 in elderly individuals between 60 to 95 years of age   living in COVID-19 hotspots in India.

Secondary objective: a) To evaluate the effectiveness of BCG vaccination in reducing the cumulative incidence of hospital admission, intensive Care admission and the incidence of other respiratory febrile illness

b) To determine the innate and adaptive immune responses, IgM, IgG and IgA antibody titers and measure biomarkers generated by BCG vaccination  in a subset of individuals. 

Study design: Intervention study

Study population: Elderly 60 – 95 years of age residing in designated red and orange zones (hotspots) for SARS-Cov2 infection

      Study Intervention: One dose of intradermal BCG vaccine.

                                        Elderly individuals not vaccinated from the same hotspot area or from neighbouring hotspot wards areas will be considered as the controls

      Study sites: Chennai, Mumbai, Ahmedabad, Bhopal, Jodhpur and New Delhi

       Study Sample size: 1450 individuals between 60 -95 years of age will receive BCG vaccination while 725 individuals will be controls without vaccination

      Study duration: Six months per participant. Enrolment at each site will be over: 4 months. Each participant will be followed for 6 months post vaccination

          Study Outcomes

Primary outcome will be reduction of morbidity and mortality due to COVID-19 disease.

Secondary endpoints include cumulative incidence of hospital admission and Intensive Care Admission. We will also look at immunological outcome in a sub-set of study participants. Multivariable regression will be used to produce estimates of vaccine effectiveness adjusted for confounders.

 


 
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