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CTRI Number  CTRI/2020/04/024846 [Registered on: 24/04/2020] Trial Registered Prospectively
Last Modified On: 25/01/2021
Post Graduate Thesis  No 
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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
30/04/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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.
 
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