A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2020/04/024846
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
1. Critically ill COVID-19 patients who have been tested positive by RT-PCR for SARS-CoV-2 on the nasopharyngeal or throat swabs.
2. Patient aged 18 years or more of either gender
3. Illness of any duration with respiratory rate �25 breaths/minute, and at least one of the following:
- SpO2 �90% on room air, or
- Requiring mechanical ventilation and/or supplemental oxygen
4. Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication.
5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.
1. Pregnant or nursing female.
2. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication
3. Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk.
4. Patient previously enrolled into this study.
5. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukemia or HIV.
6. Patients with a life expectancy judged to be less than five days
7. ALT/AST > 5 times the upper limit of normal
8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
9. Patients not likely to complete the trial as per judgment of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale. <br/ ><br> <br/ ><br>2. To evaluate 28-day mortality.Timepoint: 1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. <br/ ><br> <br/ ><br>2.Till day 28, post-randomization or death or discharge, whichever is earlier.
- Secondary Outcome Measures
Name Time Method To evaluate Change in Sequential Organ Failure Assessment (SOFA) scoreTimepoint: Baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days post-randomization.;To evaluate the safety/tolerability by determining the incidence of adverse events in the MwTimepoint: Any AE / SAE or event of clinical significance observed during the study.