This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.
Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria. Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered. Study duration for each subject will be of 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,000
Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
All India Institute of Medical Sciences, Bhopal
Bhopal, Madhya Pradesh, India
RECRUITINGPost Graduate Institute of Medical Education and Research
Chandigarh, India
RECRUITINGAll lndia Institute of Medical Science, Delhi
Delhi, India
RECRUITINGNumber of subject acquiring COVID-19 infection
To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
Time frame: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Any AE / SAE observed during the study.
Time frame: Till 8 weeks
Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
Time frame: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
Number of subject developing severe COVID-19 infection based on ordinal scale
Whether administration of Mw prevents development of severe COVID-19 infection.
Time frame: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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