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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  
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 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  
Status 
Not Applicable 
 
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.

 
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