Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19

Phase 3

Interventions: Drug: Suspension of heat killed (autoclaved) Mycobacterium w
Other: Placebo

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing.
The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.

Exclusion Criteria

Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
Subject with past history of COVID-19 infection.
Pregnant and / or lactating female subjects.
Presence of any illness requiring hospital referral.
Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
History of allergic reactions or anaphylaxis to Mw or its component.

Arm && Interventions

Group	Intervention	Description
Suspension of Mw	Suspension of heat killed (autoclaved) Mycobacterium w	Intradermal suspension of Mw will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered.
Placebo	Placebo	Placebo will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo.

Primary Outcome Measures

Name	Time	Method
Number of subject acquiring COVID-19 infection	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..	To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose

Secondary Outcome Measures

Name	Time	Method
Number of subject developing severe COVID-19 infection based on ordinal scale	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	Whether administration of Mw prevents development of severe COVID-19 infection.
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)	Till 8 weeks	Any AE / SAE observed during the study.
Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms	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.	Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.

Locations (3): All India Institute of Medical Sciences, Bhopal
🇮🇳
Bhopal, Madhya Pradesh, India
Post Graduate Institute of Medical Education and Research
🇮🇳
Chandigarh, India
All lndia Institute of Medical Science, Delhi
🇮🇳
Delhi, India