CTRI Number |
CTRI/2020/04/024846 [Registered on: 24/04/2020] 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
|
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
|
|
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)
|
|
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)= "16"
Final Enrollment numbers achieved (India)="16" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
30/04/2020 |
Date of Study Completion (India) |
03/02/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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. |