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

• Status: Recruiting
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cadila Pharnmaceuticals
• Collaborator: Council of Scientific and Industrial Research, India

Criteria

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.