Status:
COMPLETED
A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients
Lead Sponsor:
Cadila Pharnmaceuticals
Collaborating Sponsors:
Council of Scientific and Industrial Research, India
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 practi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04347174
Start Date
April 30 2020
End Date
August 21 2020
Last Update
January 27 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
All India Institute of Medical Science, Raipur
Raipur, Chhattisgarh, India, 492099
2
All India Institute of Medical Sciences, Bhopal
Bhopal, Madhya Pradesh, India, 462024
3
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
4
All lndia Institute of Medical Science, Delhi
Delhi, India, 110029