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CTRI Number  CTRI/2020/05/025271 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On: 19/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill 
Scientific Title of Study   A Randomized, Double-blind, Two arm, controlled clinical trial to compare the Efficacy and Safety of Mycobacterium w (Mw) administered along with Standard of care versus Placebo administered along with Standard of care, in adult, COVID 19 positive patients hospitalized but not critically ill. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRSC20006, version no. 02, 15.04.2020  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

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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anant Mohan  All lndia Institute of Medical Science, Delhi  A Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029.
New Delhi
DELHI 
911126588700

anantmohan88@gmail.com 
Dr Sajal De  AII India Institute of Medical Science, Raipur  Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 Raipur CHHATTISGARH
Raipur
CHHATTISGARH 
917712577372

sajalde@yahoo.com 
Dr Sarman Singh  All India Institute of Medical Sciences, Bhopal  Saket Nagar, Bhopal Madhya Pradesh, India Bhopal
Bhopal
MADHYA PRADESH 
91-755-2672317

director@aiimsbhopal.edu.in 
Dr Akash Khobragade  Grant Government Medical College & Sir J.J. Group of Hospitals  Byculla, Mumbai-400008. Maharashtra
Mumbai
MAHARASHTRA 
9702658822

akash.khobragade@gmail.com 
Dr Inderpaul Singh Sehgal   Post Graduate Institute of Medical Education and Research  Sector 12, Chandigarh 160012. India. Chandigarh
Chandigarh
CHANDIGARH 
01722756823

inderpgi@outlook.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee, AIIMS, Delhi  Approved 
Institutional Ethics Committee, AIIMS, Raipur  Approved 
Institutional Ethics Committee, JJ Group of hospital  Approved 
Institutional Ethics Committee, King Georges Medical University  Approved 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
Institutional Human Ethics Committee, AIIMS, Bhopal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  0.3 ml (0.1 ml x 3 Inj.) of intradermal Placebo for 3 consecutive days with Standard therapy of COVID-19 
Intervention  Suspension of heat killed (autoclaved)Mycobacterium w   0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days with Standard therapy of COVID-19 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. COVID-19 positive patients with ordinal scale score of 3 with comorbid illness including diabetes mellitus, hypertension, chronic lung disease, immunocompromised status, active malignancy, chronic kidney disease, chronic liver disease, obesity (BMI>25Kg/m2), or subjects who have doubling of CRP compared to baseline or have Neutrophil-to-Lymphocyte Ratio ≥3.5.
2. Patients of either gender, age ≥ 18 years at the time of enrollment.
3. Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing.
4. The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form. 
 
ExclusionCriteria 
Details  1. Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
2. Pregnant and / or lactating female patients.
3. A family history of congenital or hereditary immunodeficiency.
4. Any disease condition requiring ICU admission.
5. History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
6. History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
7. History of allergic reactions or anaphylaxis to Mw or its component.
8. Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patient’s health or is likely to result in nonconformance to the protocol or a patient’s ability to give written informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of patients with increased disease severity  From baseline to at any time during the study till 28 days post first dosing. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of adverse events and serious adverse events (Safety)  Till day 28 
Number of COVID-19 patients discharged from hospital  From baseline to at any time during the study till 28 days post first dosing. 
Number of COVID-19 patients transfer to ICU  From baseline to at any time during the study till 28 days post first dosing. 
Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale  From baseline to at any time during the study till 28 days post first dosing. 
Number of of symptom free patients  From baseline to at any time during the study till 28 days post first dosing. 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
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   Phase 3 
Date of First Enrollment (India)   31/05/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary  
In a randomized, double blind, two arms, placebo controlled, clinical trial, total 480 hospitalized adult eligible patients will be randomized to study to evaluate the the safety and efficacy of Mycobacterium w versus placebo for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.

Patients will be continued with the standard of care. Daily clinical evaluation of patient will be performed till discharge from hospital or till ICU admission.

Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.
 
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