| CTRI Number |
CTRI/2020/05/025277 [Registered on: 21/05/2020] Trial Registered Prospectively |
| Last Modified On: |
03/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant P Joshi |
All India Institute Of Medical Sciences (AIIMS), NAGPUR |
Plot No 2, Sector 20, MIHAN, Nagpur- 441108
Nagpur
MAHARASHTRA |
9822225504
drprashantpjoshi@gmail.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 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 Suneetha Narreddy |
Apollo Hospitals, Hyderabad |
Department of Medicine, Jubilee Hills, Hyderabad, Telangana, India -500096
Hyderabad
TELANGANA |
9966022225
suneethanarreddy@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 Ajay Kumar Verma |
King Georges Medical University |
Department of Respiratory Medicine, Shahmeena road Chowk, Lucknow-226003, Uttar Pradesh. India.
Lucknow
UTTAR PRADESH |
09919788862
drajay21@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= 8 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Delhi |
Approved |
| Institutional Ethics Committee, AIIMS, Nagpur |
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |