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

Cadila Pharmaceuticals

Status: Completed

Conditions: COVID-19

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04347174

CRSC20004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Suspension of Mw + Standard therapy of COVID-19

Experimental group

Description:

0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19

Treatment:

Drug: Suspension of heat killed (autoclaved) Mycobacterium w

Standard therapy of COVID-19

Placebo Comparator group

Description:

0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days

Treatment:

Drug: Placebo