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

NCT04347174 | Completed DMC

• 1 other identifier: CRSC20004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)

  To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

  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.

• Sequential Organ Failure Assessment (SOFA) scores

  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

  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 (8)

• Incidence of AE / SAE or event of clinical significance

  Till day 28

• SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample

  At days 3, 7, 14, 21, and 28

• ICU length of stay

  Till day 28

• Duration of mechanical ventilation

  Till day 28

• Duration of hospitalization

  Till day 28

Study Arms (2)

Suspension of Mw + Standard therapy of COVID-19

EXPERIMENTAL

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

Drug: Suspension of heat killed (autoclaved) Mycobacterium w

Standard therapy of COVID-19

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Suspension of heat killed (autoclaved) Mycobacterium w 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.

Also known as: Standard care of treatment for COVID-19 as per hospital practice

Suspension of Mw + Standard therapy of COVID-19

Placebo DRUG

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

Also known as: Standard care of treatment for COVID-19 as per hospital practice

Standard therapy of COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead
• Council of Scientific and Industrial Research, India: collaborator

Study Sites (4)

All India Institute of Medical Science, Raipur

Raipur, Chhattisgarh, 492099, India

Location

All India Institute of Medical Sciences, Bhopal

Bhopal, Madhya Pradesh, 462024, India

Location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

All lndia Institute of Medical Science, Delhi

Delhi, 110029, India

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anil Avhad, MBBS

  Cadila Pharmaceuticals Limited

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, patient and study staff will be blinded to the study treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, two arms, active comparator controlled, clinical trial

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 15, 2020
• Study Start: April 30, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 21, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)