| 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
|
|
|
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
|
|
|
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
|
|