CTRI

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CTRI Number

CTRI/2020/04/024846 [Registered on: 24/04/2020] Trial Registered Prospectively

Last Modified On:

13/12/2021

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

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

Scientific Title of Study

A clinical trial to evaluate the safety and efficacy of Mycobacterium W in critically ill patients suffering from COVID 19 infection

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
CRSC20004, Version no. 04, 07 October 2020	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sanjay Patel
Designation	Senior Manager
Affiliation	Cadila Pharmaceuticals Limited
Address	1389, Trasad Road Dholka, Ahmedabad Dholka, Ahmedabad Ahmadabad GUJARAT 382225 India
Phone
Fax
Email	sanjay.p@cadilapharma.co.in

Details of Contact Person
Scientific Query

Name	Dr Anil Avhad
Designation	General Manager
Affiliation	Cadila Pharmaceuticals Limited
Address	1389, Trasad Road Dholka, Ahmedabad 1389, Trasad Road Dholka, Ahmedabad Ahmadabad GUJARAT 382225 India
Phone
Fax
Email	anil.avhad@cadilapharma.co.in

Details of Contact Person
Public Query

Name	Dr Anil Avhad
Designation	General Manager
Affiliation	Cadila Pharmaceuticals Limited
Address	1389, Trasad Road Dholka, Ahmedabad 1389, Trasad Road Dholka, Ahmedabad Ahmadabad GUJARAT 382225 India
Phone
Fax
Email	anil.avhad@cadilapharma.co.in

Source of Monetary or Material Support

Cadila Pharmaceuticals Limited

Primary Sponsor

Name	Cadila Pharmaceuticals Limited
Address	1389, Trasad Road, Dholka, Ahmedabad - 382225, Gujarat, India.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 6
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Deependra Kumar Rai	All India institute of Medical Science, Patna	Department of Pulmonary Medicine Phulwarisharif Patna 810507. Bihar. India. Patna BIHAR	917764981421 drdeependrak@aiimspatna.org
Dr Md Sabah Siddiqui	All India Institute of Medical Science, Raipur	Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 Raipur CHHATTISGARH	918518881911 dr.sabah@aiimsraipur.edu.in
Dr Sarman Singh	All India Institute of Medical Sciences, Bhopal	Saket Nagar, Bhopal Madhya Pradesh, India Bhopal MADHYA PRADESH	91-755-2672317 director@aiimsbhopal.edu.in
Dr Randeep Guleria	All lndia Institute of Medical Science, Delhi	A Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 New Delhi DELHI	919810184738 randeepguleria2002@yahoo.com
Dr Inderpaul Singh Sehgal	Post Graduate Institute of Medical Education and Research	Sector 12, Chandigarh. 160012. India. Chandigarh CHANDIGARH	01722756823 inderpgi@outlook.com
Dr Bikram Kumar Gupta	Sir Sundar Lal Hospital Institute of Medical Sciences Banaras Hindu University	Division of critical care medicine, Department of Anaesthesiology & Critical Care Institute of Medical Sciences, B.H.U., Varanasi-221005 Varanasi UTTAR PRADESH	91-8317007518 bikramgupta03@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 6
Name of Committee	Approval Status
Institutional Ethics Committee, AIIMS, Delhi	Approved
Institutional Ethics Committee, AIIMS, Patna	Approved
Institutional Ethics Committee, BHU	Approved
Institutional Ethics Committee, PGIMER, Chandigarh	Approved
Institutional Human Ethics Committee, AIIMS, Bhopal	Approved
Institutional Human Ethics Committee, AIIMS, Raipur	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: B972\|\|Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J00-J99\|\|Diseases of the respiratory system,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Placebo	0.3 ml (0.1 ml x 3 Inj.) of Placebo intra-dermal for 3 consecutive days with Standard therapy of COVID-19
Intervention	Suspension of heat killed (autoclaved)Mycobacterium w	0.3 ml (0.1 ml x 3 Inj.) of Mw intra-dermal for 3 consecutive days with Standard therapy of COVID-19

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. Critically ill COVID-19 patients who have been tested positive by RT-PCR for SARS-CoV-2 on the nasopharyngeal or throat swabs. 2. Patient aged 18 years or more of either gender 3. Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following: - SpO2 ≤90% on room air, or - Requiring mechanical ventilation and/or supplemental oxygen 4. Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. 5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.

ExclusionCriteria

Details

1. Pregnant or nursing female.
2. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication
3. Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk.
4. Patient previously enrolled into this study.
5. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukemia or HIV.
6. Patients with a life expectancy judged to be less than five days
7. ALT/AST > 5 times the upper limit of normal
8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
9. Patients not likely to complete the trial as per judgment of the investigator.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome
Modification(s)

Outcome	TimePoints
1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale. 2. To evaluate 28-day mortality.	1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. 2.Till day 28, post-randomization or death or discharge, whichever is earlier.

Secondary Outcome
Modification(s)

Outcome	TimePoints
To evaluate Change in Sequential Organ Failure Assessment (SOFA) score	Baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days post-randomization.
To evaluate the safety/tolerability by determining the incidence of adverse events in the Mw	Any AE / SAE or event of clinical significance observed during the study.

Target Sample Size
Modification(s)

Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16"

Phase of Trial
Modification(s)

Phase 3

Date of First Enrollment (India)
Modification(s)

30/04/2020

Date of Study Completion (India)

03/02/2020

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

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 water for injection, intradermal, for 3 consecutive days.

Study duration for each patient will be upto 28 days post-randomization.