Clinical Trial of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025277
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy subjects with recent history of close contact with COVID-19 patients.
2.Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
3.Subject of either gender, age >= 18 years at the time of enrollment.
4.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 3 months post-dosing.
5.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.
1.Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
2.Subject with past history of COVID-19 infection.
3.Pregnant and / or lactating female subjects.
4.Presence of any illness requiring hospital referral.
5.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 immunosuppressantâ??s as Azathioprine, Cyclosporine, Mycophenolate etc.
6.History of allergic reactions or anaphylaxis to Mw or its component.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o. of subjects acquiring COVID-19 infectionTimepoint: From first dosing till 8 week post first dosing.
- Secondary Outcome Measures
Name Time Method Development of severe COVID-19 infection based on ordinal scaleTimepoint: From first dosing till 8 week post first dosing;Development of Upper Respiratory Tract Infection (URTI) symptoms.Timepoint: From first dosing till 8 week post first dosing;Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)Timepoint: Till 8 weeks