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

Phase 3

Completed

Conditions: Diseases of the respiratory system, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,

Brief Summary: 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 water for injection, intradermal, for 3 consecutive days.

Study duration for each patient will be upto 28 days post-randomization.

Recruitment & Eligibility

Inclusion Criteria

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 â‰¥25 breaths/minute, and at least one of the following:.
SpO2 â‰¤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.

Exclusion Criteria

Pregnant or nursing female.
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.
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, leukemia or HIV.
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.

Primary Outcome Measures

Name	Time	Method
1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale.	1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. \| 2.Till day 28, post-randomization or death or discharge, whichever is earlier.
2. To evaluate 28-day mortality.	1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. \| 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) score	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 Mw	Any AE / SAE or event of clinical significance observed during the study.

Locations (6): All India institute of Medical Science, Patna
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Patna, BIHAR, India
All India Institute of Medical Science, Raipur
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Raipur, CHHATTISGARH, India
All India Institute of Medical Sciences, Bhopal
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Bhopal, MADHYA PRADESH, India
All lndia Institute of Medical Science, Delhi
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Delhi, DELHI, India
Post Graduate Institute of Medical Education and Research
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Chandigarh, CHANDIGARH, India
Sir Sundar Lal Hospital Institute of Medical Sciences Banaras Hindu University
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Varanasi, UTTAR PRADESH, India
All India institute of Medical Science, Patna
🇮🇳Patna, BIHAR, India
Dr Deependra Kumar Rai
Principal investigator
917764981421
drdeependrak@aiimspatna.org