| CTRI Number |
CTRI/2020/05/025271 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
13/12/2021 |
| 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 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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| 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 Prashant P Joshi |
All India Institute of Medical Sciences, Nagpur |
Plot No 2, Sector 20, MIHAN, Nagpur- 441108
Nagpur
MAHARASHTRA |
9822225504
drprashantpjoshi@gmail.com |
| 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 Surya Kant |
King Georges Medical University |
Department of Respiratory Medicine, Shahmeena road Chowk, Lucknow-226003, Uttar Pradesh. India
Lucknow
UTTAR PRADESH |
09415016858
skantpulmed@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= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee, AIIMS, Delhi |
Approved |
| Institutional Ethics Committee, AIIMS, Nagpur |
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
|
|
|
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 |
0.3 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)= "481"
Final Enrollment numbers achieved (India)="481" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2020 |
| Date of Study Completion (India) |
13/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |