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CTRI Number  CTRI/2020/05/025350 [Registered on: 26/05/2020] Trial Registered Prospectively
Last Modified On: 26/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Trial 
Public Title of Study   Study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 
Scientific Title of Study   Observational study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 at R D Gardi Medical College, Ujjain, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Pathak 
Designation  Professor 
Affiliation  R D Gardi Medical College 
Address  3rd Floor, Department of Pediatrics C R Gardi Medical College
R D Gardi Medical College Agar Road, Surasa
Ujjain
MADHYA PRADESH
456006
India 
Phone  9302239899  
Fax    
Email  drashish.jpathak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Pathak 
Designation  Professor 
Affiliation  R D Gardi Medical College 
Address  3rd Floor, Department of Pediatrics C R Gardi Medical College
R D Gardi Medical College Agar Road, Surasa
Ujjain
MADHYA PRADESH
456006
India 
Phone  9302239899  
Fax    
Email  drashish.jpathak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish Pathak 
Designation  Professor 
Affiliation  R D Gardi Medical College 
Address  3rd Floor, Department of Pediatrics C R Gardi Medical College
R D Gardi Medical College Agar Road, Surasa
Ujjain
MADHYA PRADESH
456006
India 
Phone  9302239899  
Fax    
Email  drashish.jpathak@gmail.com  
 
Source of Monetary or Material Support  
R D Gardi Medical College Agar Road, Surasa Ujjain MADHYA PRADESH 456006 India 
 
Primary Sponsor  
Name  R D Gardi Medical College 
Address  Agar Road, Surasa Ujjain MADHYA PRADESH 456006 India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Pathak  R D Gardi Medical College, Ujjain   3rd Floor, Department of Pediatrics C R Gardi Medical College
Ujjain
MADHYA PRADESH 
9302239899

drashish.jpathak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, R D Gardi Medical College, Ujjain   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Sepsivac   0.3 ml/day of Inj. Sepsivac will be administered as intra-dermal injections for three consecutive days as 0.1ml x 3 injections at different sites along with standard therapy ofCovid-19. The investigational product is an auto claved suspension in physiological saline of Mw .Each dose of 0.1ml contains: Mycobacteriumw,(heatkilled) 0.5x109 Sodium ChlorideI.P. 0.9%w/v Thimerosal I.P. 0.01%w/v(As a Preservative) Water for injection I.P. q.s.to 0.1ml  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients between the age of 18 – 65 years diagnosed to have Covid19 infection confirmed by RTPCR assay,
and
any one or more of the following

1. Either an oxygen saturation of 94% or less while the patient was breathing ambient air or a need for oxygen support
2. Creatinine clearance above 30 ml per minute
3. Serum levels of ALT and AST less than five times the upper limit of the normal range
4. Requirement of vasopressor

 
 
ExclusionCriteria 
Details  1. Pregnant or nursing female.
2. Patient previously enrolled into similar study.
3. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
4. Patients not likely to complete the trial as per judgment of the investigator. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a modified ordinal scale (as recommended by the WHO R&D Blueprint Group)

Conversion of Covid19 status to negative 
28 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Overall safety of the study drug
2. Duration of hospitalization
3. Improvement in the abnormal laboratory values
 
28 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   31/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Results will be published in relevant open access peer-reviewed scientific journals. 
Brief Summary  

This study titled - International study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 at R D Gardi Medical college, Ujjain, Madhya Pradesh is a single arm, open label, observational study. The objective of this single centre study is to evaluate safety and efficacy of Inj Sepsivac, (Mycobacterium w repurposed drug for severe gram negative sepsis) in patients of Covid-19. Sample size is 50 patients with inclusion criteria of age between 18 – 65 years diagnosed to have Covid19 infection confirmed by RTPCR assay, and any one or more of the following:  a) either an oxygen saturation of 94% or less while the patient was breathing ambient air or a need for oxygen support, b) creatinine clearance above 30 ml per minute, c) serum levels of ALT and AST less than five times the upper limit of the normal range and d) requirement of vasopressor. Patients will be recruited till maximum of 6 months. The follow up of patient will be till 28 days with following schedule: daily till 7 days, then on 14 and 28 days. The follow-up will include clinical follow up and certain laboratory parameters like liver functions and renal functions.


 
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