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

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

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