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

Cadila Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: COVID-19

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04353518

CRSC20005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,000 participants in 2 patient groups, including a placebo group

Suspension of Mw

Experimental group

Description:

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.

Treatment:

Drug: Suspension of heat killed (autoclaved) Mycobacterium w

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo