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CTRI Number  CTRI/2020/05/025277 [Registered on: 21/05/2020] Trial Registered Prospectively
Last Modified On: 16/09/2020
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 Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19 
Scientific Title of Study   A Randomized, Double-blind, Two arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in preventing COVID-19 in subjects at risk of getting infected with COVID-19. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRSC20005, 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
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 1389, Trasad Road, Dholka, Ahmedabad – 382225, Gujarat, India. 
 
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 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 Ajoy Kumar Behera  All India Institute of Medical Sciences, Raipur  Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 
8518881794

drajoybeherakims@gmail.com 
Dr Sushma Bhatnagar  All lndia Institute of Medical Science, Delhi  A Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029.
New Delhi
DELHI 
919811326453

sushmabhatnagar1@gmail.com 
Dr Akash Khobragade  Grant Government Medical College & Sir J.J. Group of Hospitals  Byculla, Mumbai-400008.
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 
01722756823

inderpgi@outlook.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Delhi  Approved 
Institutional Ethics Committee, AIIMS, Raipur  Approved 
Institutional Ethics Committee, Apollo, Hyderabad  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  0.2 ml (0.1 ml x 2 Inj.) of intradermal Placebo on day 0 and 0.1 ml of intradermal Placebo on day 15 
Intervention  Suspension of heat killed (autoclaved)Mycobacterium w  0.2 ml (0.1 ml x 2 Inj.) of intradermal Mw on day 0 and 0.1 ml of intradermal Mw on day 15 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Healthy subjects with recent history of close contact with COVID-19 patients.
2.Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
3.Subject of either gender, age ≥ 18 years at the time of enrollment.
4.Female subject 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.
5.The subject 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.Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
2.Subject with past history of COVID-19 infection.
3.Pregnant and / or lactating female subjects.
4.Presence of any illness requiring hospital referral.
5.Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant’s as Azathioprine, Cyclosporine, Mycophenolate etc.
6.History of allergic reactions or anaphylaxis to Mw or its component. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
No. of subjects acquiring COVID-19 infection  From first dosing till 8 week post first dosing. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)  Till 8 weeks 
Development of Upper Respiratory Tract Infection (URTI) symptoms.  From first dosing till 8 week post first dosing 
Development of severe COVID-19 infection based on ordinal scale  From first dosing till 8 week post first dosing 
 
Target Sample Size   Total Sample Size="4000"
Sample Size from India="4000" 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary  
Approximately 4000 eligible subjects who are at risk of getting infected with COVID-19 will be enrolled in to this randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in preventing COVID-19 infection.

Subjects will be randomized in 1:1 ratio to receive either Mw or placebo. Study duration for each subject will be of 8 weeks.
 
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