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CUReD:  CSIR Ushered Repurposed Drugs -  A website that provides information on CSIR Partnered Clinical Trials.

   Details of Sepsivac

Name of trial Protocol No. CRSC20004 Study Title: ‘A clinical trial to evaluate the safety and efficacy of Mw in critically ill patients suffering from COVID 19 infection’.
CSIR lab/s involved Industry Partner/s involved Academic Partner/s & Associated Hospitals

Council of Scientific & Industrial Research (CSIR) through its New Millennium Indian Technology Leadership Initiative (NMITLI) program

Cadila Pharmaceuticals Ltd.
Survey No.1389, Trasad Road Dholka, Ahmedabad -387810
  1. Post Graduate Institute of Medical Education and Research, Chandigarh
  2. All India Institutes of Medical Sciences, Bhopal
  3. All India Institutes of Medical Sciences, New Delhi
  4. All India Institutes of Medical Sciences, Raipur
  5. Banaras Hindu University, Varanasi
Type of Drug Injection Mycobacterium Welchi  (Mw)-Immunomodulator
IP Status of Drug/s

Data sheet for clinical trial information of Pharmaceuticals

 No. Patent/ Application no. Country
1
ZA 200903523
South Africa
2
US 8333978
USA
3
JP 5358450
Japan
4
GB 2450580
UK
5
EP 2096914
Europe
6
AU 2007323134
Australia
7
EA 023046
Eurasia
8
CA 2670124
Canada
9
IN 1931/MUM/2006
India
10
AP 2752
Aripo
11
EP 2359837
Europe
Mechanism of Action & Scientific rationale for Covid-19

In COVID -19 there is immune dysregulation. This is similar to immune dysregulation seen in gram- negative sepsis.

Mw is found useful in reducing morbidity and mortality in gram- negative sepsis by controlling immune dysregulation. It is an approved product in India for gram- negative sepsis. Since, both the conditions are identical it is being evaluated in COVID -19
Combinations therapy or monotherapy Monotherapy added to standard of care in COVID-19 (Inj. Mw 0.3 ml intradermal for 3 days along with Standard of Care in COVID 19)
Trial design: A randomized, double blind, Placebo controlled, two arms, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard of care as per hospital practices versus Placebo along with standard of care in critically ill adult patients suffering from COVID 19 infection. Health Condition / Problems Studied Health Type Condition
Adult Patient COVID-19

Number of trial sites       

Number of arms              

Number of patients         

04

02

40 patients initially followed by additional 300 patients

End points (primary and secondary)
Primary

  • To study the effect of Mw on recovery of organ function as assessed by change in Ordinal Scale

{Time frame: From baseline to day 3, 7, 14, 21 and day 28 and day of transfer from ICU, if
discharged earlier than 28 days post-randomization.}

      • 28-day mortality.

             {Time frame: Till day 28, post-randomization or death or discharge, whichever is earlier}

Secondary / Exploratory

  • SOFA scores (Refer below table): {Time frame: Change in SOFA score from baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days post-randomization.}
      • 28 days mortality during study.
      • Any AE / SAE or event of clinical significance observed during the study.
      • ICU length of stay
      • Duration of mechanical ventilation
      • Duration of hospitalization
      • Time (in days) from treatment initiation to death.
      • Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample at days 3, 7, 14, 21, and 28.
      • Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale from base line at day 14 & Day 28.
Status of the trial  Ongoing

Name & details of Clinical PI/s

1. Dr. Inderpaul Singh Sehgal

 

 

 

 

2. Dr. Sarman Singh

 

 

 

 

3. Dr. RandeepGuleria

 

 

 

 

 

4. Dr. Md. Sabah Siddiqui

 

 

 

 

 

5. Dr. Bikram Kumar Gupta

Post Graduate Institute
of Medical Education
and Research

 

 

 

All India Institute of
Medical Sciences,
Bhopal

 

 

All India Institute of
Medical Sciences,
New Delhi

 

 

 

 

All India Institute of
Medical Sciences,
Raipur

 

 

 

 

 

Sir Sundar Lal Hospital
Institute of Medical
Sciences Banaras Hindu University

 

Sector 12, Chandigarh.
160012. India.
Chandigarh
CHANDIGARH
Ph:01722756823
inderpgi@outlook.com

 

Saket Nagar, Bhopal
Madhya Pradesh, India
Bhopal
MADHYA PRADESH
Ph:91-755-2672317
director@aiimsbhopal.edu.in

 

A Sri Aurobindo Marg,
Ansari Nagar, Ansari
Nagar East, New Delhi,
Delhi 110029
New Delhi
DELHI
Ph:919810184738
randeepguleria2002@yahoo.com

 

Great Eastern Rd,
AIIMS Campus,
Tatibandh, Raipur,
Chhattisgarh 492099
Raipur
CHHATTISGARH
Ph:918518881911
dr.sabah@aiimsraipur.edu.in

 

Division of critical care
medicine, Department
of Anaesthesiology &
Critical Care Institute of
Medical Sciences,
B.H.U.,Varanasi-221005;UP
ph:91-8317007518 bikramgupta03@gmail.com

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