To study the effect of BCG vaccine in Reducing the Incidence and severity of COVID-19 in the high-risk populatio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026668
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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)
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.Timepoint: 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. <br/ ><br>2.Incidence of Adverse events following immunization (AEFIs) associated with BCG vaccine. <br/ ><br>3.The change of titers of PPD-specific IgM and IgG following BCG vaccination <br/ ><br>Timepoint: 9 months