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CTRI Number  CTRI/2020/08/027475 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 01/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Controlled Trial Of An Immunomodulator Mycobacterium w In Mild To Moderate Covid-19 Pneumonia 
Scientific Title of Study   "Randomized Controlled Trial Of Immunomodulator Mycobacterium w In Mild And Moderate Cases of Covid-19 Pneumonia" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shweta Ram Chandankhede 
Designation  Critical Care Consultant 
Affiliation  Care Hospital, anjara hills 
Address  Road 1, Care Hospital, Banjara Hills,Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9963431945  
Fax    
Email  shwets0106@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Ram Chandankhede 
Designation  Critical Care Consultant 
Affiliation  Care Hospital, Banjara Hills 
Address  Care Hospital,Banjara Hills,Hyderabad.

Hyderabad
TELANGANA
500034
India 
Phone  9963431945  
Fax    
Email  shwets0106@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Ram Chandankhede 
Designation  Critical Care Consultant 
Affiliation  Care Hospital, Banjara Hills 
Address  Care Hospital,Banjara Hills, Hyderabad.

Hyderabad
TELANGANA
500034
India 
Phone  9963431945  
Fax    
Email  shwets0106@gmail.com  
 
Source of Monetary or Material Support  
Cadila Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Cadila Pharmaceuticals Limited 
Address  Trasad Road Dholka 1389 Ahmadabad,Pincode-387810(India) 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Shweta Ram Chandankhede  Care Hospital,Banjara Hills  Road Number 1, Banjara Hills
Hyderabad
TELANGANA 
9963431945

shwets0106@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Care Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B342||Coronavirus infection, unspecified,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  inj sepsivac 0.3 ml intradermal once a day for 3 days  inj sepsivac 0.3 ml intradermal once a day for 3 days 
Comparator Agent  normal saline  0.3 ml intradermal once a day for 3 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age More Than 18 in both genders.
Mild to moderate covid 19 pneumonia
Consented for study 
 
ExclusionCriteria 
Details  Pregnancy,
Received cardiopulmonary resuscitation,
On long standing immunosuppressive therapy,
Unwilling to provide consent.
Complete blood count serum D‑dimer, C‑reactive protein (CRP), procalcitonin and IL6 levels will be done for all patients. As per our institutional protocol, all patients will receive standard medical care comprising oral paracetamol (for fever), oral proton pump inhibitor for stress ulcer prophylaxis (pantoprazole 40 mg/day), and low molecular weight heparin for deep venous thrombosis prophylaxis (enoxaparin 1 mg/kg, once daily). Therapeutic anticoagulation (enoxaparin 1 mg/kg, twice daily) will be given in patients who will have D dimer levels >500 ng/ mL. Dexamethasone 6 mg iv daily will be used for 7 days. Antibiotics (azithromycin or doxycycline ) will be used in patients with a total leukocyte count of >11,000 cell/μL, procalcitonin >0.5 ng/mL, or if they have hypotension (mean arterial blood pressure <65 mmHg). We will not use hydroxychloroquine in any of these patients. We will use intradermal Mw (0.3 mL/day [0.1 mL contains 0.5 × 109 heat- killed Mw] for 3 consecutive days, in addition to standard medical care.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
28 days mortality  28 days mortality 
 
Secondary Outcome  
Outcome  TimePoints 
Ventilator Free Days,
Icu Days,
Hospital Stay. 
28 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   01/09/2020 
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="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  


 
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