A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients

• Status: Completed
• Trial end date: 2020-08-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Pharnmaceuticals
• Collaborator: Council of Scientific and Industrial Research, India

Criteria

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.