This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.
Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive
either Mw+SOC or placebo+SOC for first 3 days post-randomization.
Daily clinical evaluation of patient will be performed till discharge from hospital or till
ICU admission.
Study duration for each patient will be approximately up to 28 days, or discharge from
hospital or transfer to ICU, whichever is earlier.
Drug: Suspension of heat killed (autoclaved) Mycobacterium w
Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
Other: Placebo
Placebo along with Standard of care (SOC) treatment for COVID-19
Inclusion Criteria:
- COVID-19 positive patients with ordinal scale score of 3.
- Patients of either gender, age ≥ 18 years at the time of enrollment.
- Female patients 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.
- The patients 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:
- Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
- Pregnant and / or lactating female patients.
- A family history of congenital or hereditary immunodeficiency.
- Any disease condition requiring ICU admission.
- History of dialysis, silicosis, solid organ transplantation such as renal or cardiac
transplants, and disorders of the heart, or nervous system, or other metabolic
inflammatory conditions, psychiatric, occupational problems that make it unlikely that
the patients will comply with the protocol as determined by the investigator.
- History of administration of any immunoglobulins, any immunotherapy (antineoplastic
chemotherapy, radiation therapy, immunosuppressants to induce tolerance to
transplants, and corticosteroids use) and/or any blood products within the 3 months
preceding study dosing, or planned future administrations during the study period.
- History of allergic reactions or anaphylaxis to Mw or its component.
- Presence of any severe systemic/autoimmune disorders as determined by medical history
and/or physical examination at the time of screening, which in the judgment of the
Investigator would compromise the patient's health or is likely to result
nonconformance to the protocol or a patient's ability to give written informed
consent.
All India Institute of Medical Science, Raipur
Raipur, Chhattisgarh, India
All India Institute of Medical Sciences, Bhopal
Bhopal, India
Post Graduate Institute of Medical Education and Research
Chandigarh, India
All India Institute of Medical Sciences, Delhi
Delhi, India
Anil Avhad, MBBS
919833454044
anil.avhad@cadilapharma.co.in
Ashish Amarsheda
919898073861
ashish.a@cadilapharma.co.in
Sanjay Patel, MBBS, Study Chair
Cadila Pharmaceuticals Limited