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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. CRSC20005 Study Title: 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.
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 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

Innate immune mechanism: Efficient early defense mechanism against infection, irrespective of  type of pathogen or history of prior exposure  (must for adaptive immune response). Mw is a potent TLR2 agonist; induces pure potent Th1 response, activates  Macrophages, NK cells, dendritic cells (innate immunity).
In COVID -19 there is immune dysregulation.
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.

By inducing potent innate response of Th1 type, Mw is expected to provide protection to at risk population.

Combinations therapy or monotherapy Inj. Mw 0.2 ml intradermal Dose 1: At Day 0 and  Inj. Mw 0.1 ml intradermal  Dose 2: At week 02.
Trial design: 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. Health Condition / Problems Studied Health Type Condition
  Adult Patient COVID-19

Number of trial sites       

Number of arms              

Number of patients         

04

02

4000 subjects

End points (primary and secondary)
Primary:
• To compare proportion of subjects acquiring COVID-19 infection between two arms over the time
till 8 weeks from administration of 1st dose.

Secondary :

  • Incidence of adverse events and serious adverse events in study subjects till the end of the study period.
  • To compare proportion of subjects developing URTI between two arms over the time.
  • To evaluate difference in severity of COVID-19 between two arms
  • To compare the proportion of subjects developing COVID-19 disease with peak ordinal scale of ≤3 or ≥ 4 in both the arms over the time.
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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