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.
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.
Drug: Suspension of heat killed (autoclaved) Mycobacterium w
Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
Other: Placebo
Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
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.
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
Sanjay Patel, MBBS
+912714221481 - 270
sanjay.p@cadilapharma.co.in
Ashish Amarsheda, M.Pharm
+919898073861
ashish.a@cadilapharma.co.in
Anil Avhad, MBBS, Study Chair
Cadila Pharmaceuticals Limited