Clinical trial NCT04347174: A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients
Official title: A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Council of Scientific and Industrial Research, India
First posted: 2020-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, blinded, two arms, active comparator controlled, clinical trial
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)
timeFrame: 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.
measure: Sequential Organ Failure Assessment (SOFA) scores
timeFrame: 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.
Secondary outcomes:
measure: Incidence of AE / SAE or event of clinical significance
timeFrame: Till day 28
measure: SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample
timeFrame: At days 3, 7, 14, 21, and 28
measure: ICU length of stay
timeFrame: Till day 28
measure: Duration of mechanical ventilation
timeFrame: Till day 28
measure: Duration of hospitalization
timeFrame: Till day 28
measure: Clinical improvement
timeFrame: From baseline to day 14 & Day 28
measure: Time (in days) from treatment initiation to death
timeFrame: Till day 28
measure: All-cause mortality
timeFrame: Till day 28
Other outcomes:
Locations:
city: Raipur
country: India
facility: All India Institute of Medical Science, Raipur
state: Chhattisgarh
city: Bhopal
country: India
facility: All India Institute of Medical Sciences, Bhopal
state: Madhya Pradesh
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
city: Delhi
country: India
facility: All lndia Institute of Medical Science, Delhi
Study officials:
affiliation: Cadila Pharmaceuticals Limited
name: Anil Avhad, MBBS
role: STUDY_CHAIR
References: