The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
In this study, Eligible patients will be enrolled after due consent and will be randomized in
balance to receive either test drug (along with the standard of care) or Placebo (along with
the standard of care). The enrolled patients will be monitored for any adverse events (AEs)
or serious adverse events (SAEs) throughout the study period. All patients will continue to
receive standard therapy till considered requisite by the treating physician.
In addition to the standard care for COVID-19, patients randomized to test arm will receive
single daily dose of 0.3 ml of Mw, intradermal, for 3 consecutive days while patients
randomized to control arm will receive single daily dose of 0.3 ml of Placebo, intradermal,
for 3 consecutive days.
Study duration for each patient will be upto 28 days post-randomization.
Drug: Suspension of heat killed (autoclaved) Mycobacterium w
Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.
Other Name: Standard care of treatment for COVID-19 as per hospital practice
Drug: Placebo
All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
Other Name: Standard care of treatment for COVID-19 as per hospital practice
Inclusion Criteria:
- Critically ill patients infected with COVID-19 (clinical/confirmed)
- Patient aged 18 years or more of either gender
- Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of
the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or or
- SpO2 ≤94% on room air, or
- Requiring mechanical ventilation and/or supplemental oxygen
- Female patients of childbearing potential must have a negative pregnancy test within
14 days prior to first dose of study medication.
- Subject (or legally authorized representative) provides written informed consent prior
to initiation of any study procedure.
Exclusion Criteria:
- Pregnant or nursing female.
- Patients with history of allergy, hypersensitivity, or any serious reaction to study
medication
- Patients with a concomitant medical condition, whose participation, in the opinion of
the investigator, may create an unacceptable additional risk.
- Patient previously enrolled into this study.
- Patient participating or having participated in a clinical trial with another
investigational drug within the last 28 days except for investigational drugs against
cancer, leukaemia or HIV.
- Patients with a life expectancy judged to be less than five days
- ALT/AST > 5 times the upper limit of normal
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
- Patients not likely to complete the trial as per judgment of the investigator.
All India Institute of Medical Science, Raipur
Raipur, Chhattisgarh, India
All India Institute of Medical Sciences, Bhopal
Bhopal, Madhya Pradesh, India
Postgraduate Institute of Medical Education and Research
Chandigarh, India
All lndia Institute of Medical Science, Delhi
Delhi, India
Anil Avhad, MBBS, Study Chair
Cadila Pharmaceuticals Limited