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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. CRSC20006 Study Title: 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.
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
Type of Drug Injection Mycobacterium Welchii  (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 for Covid-19
Combinations therapy or monotherapy Monotherapy added to standard of care (Inj. Mw 0.3 ml intradermal for 3 days along with Standard of Care in COVID 19 patients)
Trial design: 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. Health Condition / Problems Studied Health Type Condition
  Adult Patient COVID-19

Number of trial sites       

Number of arms              

Number of patients         

 04

02

480

End points (primary and secondary)
Primary end-point:

  • To compare the difference in proportion of patients with increased disease severity defined as progression to ordinal scale of >3 over the time between the two arms.

Secondary end-points:

  • To compare the incidence of adverse events and serious adverse events between the two arms till the end of study.
  • To compare the proportion of patients discharged from hospital* or transfer to ICU over the time   between the two arms.
  • To compare the proportion of patients with reduction in disease severity by 1 ordinal scale over the time between the two arms.
  • To compare the proportion of symptom free patients over the time between the two arms.

Exploratory end-points:

  • To compare the proportion of patients with negative COVID-19 test over the time between two arms.
  • To compare the SARS-Cov-02 specific immunoglobulins level with recovery between two arms at the end of study.
  • To compare the proportion of patients achieving normal lymphocyte count over the time between the two arms.
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

 

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

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

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