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

Not Applicable

Completed

Interventions: Drug: Suspension of heat killed (autoclaved) Mycobacterium w
Drug: Placebo

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 practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.

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 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Suspension of Mw + Standard therapy of COVID-19	Suspension of heat killed (autoclaved) Mycobacterium w	0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19
Standard therapy of COVID-19	Placebo	0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days

Primary Outcome Measures

Name	Time	Method
7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)	Change in Ordinal scale from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.	To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Sequential Organ Failure Assessment (SOFA) scores	Change in SOFA score from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.	To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	Till day 28	Duration of mechanical ventilation
ICU length of stay	Till day 28	ICU length of stay
Incidence of AE / SAE or event of clinical significance	Till day 28	Any AE / SAE or event of clinical significance observed during the study.
SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample	At days 3, 7, 14, 21, and 28	Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
Duration of hospitalization	Till day 28	Duration of hospitalization
Time (in days) from treatment initiation to death	Till day 28	Time (in days) from treatment initiation to death.
Clinical improvement	From baseline to day 14 & Day 28	Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
All-cause mortality	Till day 28	All-cause mortality

Locations (4): All lndia Institute of Medical Science, Delhi
🇮🇳
Delhi, India
Postgraduate Institute of Medical Education and Research
🇮🇳
Chandigarh, India
All India Institute of Medical Sciences, Bhopal
🇮🇳
Bhopal, Madhya Pradesh, India
All India Institute of Medical Science, Raipur
🇮🇳
Raipur, Chhattisgarh, India