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

NCT ID: NCT04347174

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2020-08-21

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Suspension of Mw + Standard therapy of COVID-19

0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days

+ Standard therapy of COVID-19

Group Type: EXPERIMENTAL

Suspension of heat killed (autoclaved) Mycobacterium w

Intervention Type: DRUG

Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.

Standard therapy of COVID-19

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician

Interventions

Suspension of heat killed (autoclaved) Mycobacterium w

Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.

Intervention Type: DRUG

Placebo

All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician

Intervention Type: DRUG

Other Intervention Names

Standard care of treatment for COVID-19 as per hospital practice; Standard care of treatment for COVID-19 as per hospital practice

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Council of Scientific and Industrial Research, India

OTHER_GOV

Sponsor Role: collaborator

Cadila Pharnmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anil Avhad, MBBS

Role: STUDY_CHAIR

Cadila Pharmaceuticals Limited

Locations

All India Institute of Medical Science, Raipur

Raipur, Chhattisgarh, India

All India Institute of Medical Sciences, Bhopal

Bhopal, Madhya Pradesh, India

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

All lndia Institute of Medical Science, Delhi

Delhi, , India

Countries

India

Other Identifiers

CRSC20004

Identifier Type: -

Identifier Source: org_study_id