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

A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Suspension of heat killed (autoclaved) Mycobacterium w; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research
  • Delhi, India, 110029
    • All lndia Institute of Medical Science, Delhi
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 492099
      • All India Institute of Medical Science, Raipur
  • Madhya Pradesh
    • Bhopal, Madhya Pradesh, India, 462024
      • All India Institute of Medical Sciences, Bhopal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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.; Other Names: Standard care of treatment for COVID-19 as per hospital practice
Placebo Comparator: Standard therapy of COVID-19; 0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days	Drug: Placebo; All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician; Other Names: Standard care of treatment for COVID-19 as per hospital practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cadila Pharnmaceuticals
• Collaborators: Council of Scientific and Industrial Research, India
• Investigators: Study Chair: Anil Avhad, MBBS, Cadila Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): August 10, 2020
• Study Completion (Actual): August 21, 2020

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CRSC20004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No