| 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 Study |
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 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. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|