Status:
UNKNOWN
Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
Lead Sponsor:
Cadila Pharnmaceuticals
Collaborating Sponsors:
Council of Scientific and Industrial Research, India
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 prac...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT04353518
Start Date
June 30 2020
End Date
May 30 2021
Last Update
December 22 2020
Active Locations (3)
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1
All India Institute of Medical Sciences, Bhopal
Bhopal, Madhya Pradesh, India, 462024
2
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012.
3
All lndia Institute of Medical Science, Delhi
Delhi, India, 110029