| CTRI Number |
CTRI/2020/07/026608 [Registered on: 15/07/2020] Trial Registered Prospectively |
| Last Modified On: |
15/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs methylprednisolone and dexamethasone in patients with severe COVID-19 |
|
Scientific Title of Study
|
Randomized Study Of the Effect of Dexamethasone and Methylprednisolone on levels of IL-6 and clinical outcome in severe COVID-19 |
| Trial Acronym |
REDMIC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananthakumar P K |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of General Medicine
A Block
Chettinad Hospital and Research Institute
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9620916481 |
| Fax |
|
| Email |
drananthakumarpk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof V R Mohan Rao |
| Designation |
Professor and Head of the Department |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of General Medicine
A Block
Chettinad Hospital and Research Institute
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841210011 |
| Fax |
|
| Email |
medicinehod@chettinadhealthcity.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananthakumar P K |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of General Medicine
A Block
Chettinad Hospital and Research Institute
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9620916481 |
| Fax |
|
| Email |
drananthakumarpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute
Kelambakkam
603103 |
|
|
Primary Sponsor
|
| Name |
Dr Ananthakumar P K |
| Address |
Chettinad Hospital and Research Institute
Kelambakkam
Kancheepuram Dist
Pin 603103 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ananthakumar P K |
Chettinad Hospital and Research Institute |
Department of General Medicine
A Block
Kancheepuram
TAMIL NADU |
9620916481
drananthakumarpk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
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 |
| Comparator Agent |
Injection Dexamethasone |
6 mg intravenous once a day for 3 days |
| Intervention |
Injection Methylprednisolone |
1 mg/kg Intravenous once a day for 3 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years old
Both sex
Lab. Confirmed COVID-19 cases with ARDS
|
|
| ExclusionCriteria |
| Details |
Mild and moderate COVID-19
Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
Pregnant or lactating women
Patients already on steroids
Patients with High Procalcitonin level
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
Difference in IL-6 level from baseline.
Days to ventilator liberation
Length of hospital stay (LOS).
In-hospital all-cause mortality.
The secondary outcomes
Time to fever resolution
Levels of bio-markers (CRP, D dimer, Ferritin) on Day 1 and Day 3.
|
Day 1 and Day 3 for IL-6 level
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
patient details like baseline demographic data, laboratory reports – lymphocyte count, CRP, procalcitonin, Ferritin, D-dimer and clinical parameters including length of hospital stay and days in ventilator will be recorded before and after treatment with dexamethasone/methylprednisolone.
|
from day 1 to day 3 for variation in CRP
ferritin |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/07/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised,parallel group,single-centre trial comparing the effect of methylprednisolone 1mg/kg intravenous once a day for 3 days and intravenous dexamethasone 6 mg once a day for 3 days in 40 patients in India. The primary outcome measures are difference in IL-6 level from baseline,days to ventilator liberation, length of hospital stay, in hospital all cause mortality and the secondary outcomes are time to fever resolution, levels of biomarkers(CRP,D dimer,Ferritin) on day 1 and day 3. |