| CTRI Number |
CTRI/2021/11/038317 [Registered on: 29/11/2021] Trial Registered Prospectively |
| Last Modified On: |
28/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparasion of two different doses of methylprednisolone with dexamethasone in patients with severe COVID 19 patients . |
|
Scientific Title of Study
|
Effects of two different doses of methylprednisolone versus conventional dose of dexamethasone on recovery in patients with severe COVID 19 infection - A prospective randomised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Praveena R |
| Designation |
Post graduate Medical Student |
| Affiliation |
BMCRI |
| Address |
Department of Anaesthesiology, Bangalore Medical college and Research institute, K R Market , Bangalore Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
Praveenar03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaykumar H N |
| Designation |
Associate professor |
| Affiliation |
BMCRI |
| Address |
Department of Anaesthesiology, Bangalore Medical college and Research institute, K R Market , Bangalore Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
Vijay.bmc.ccm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaykumar H N |
| Designation |
Associate professor |
| Affiliation |
BMCRI |
| Address |
Department of Anaesthesiology, Bangalore Medical college and Research institute, K R Market , Bangalore Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
Vijay.bmc.ccm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute , K R Market, 560002 , Bangalore |
|
|
Primary Sponsor
|
| Name |
Government medical college |
| Address |
Department of Anaesthesiology , Bangalore Medical College and Research Institute , K R Market , 560002 , Bangalore |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vijaykumar H N |
Department of Anaesthesiology , Bangalore Medical College and Research Institute , K R Market , 560002 , Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveena R |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology , Bangalore Medical College and Research Institute , K R Market , 560002 , Bangalore
Bangalore
KARNATAKA |
9110248311
Praveenar03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI 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 |
Dexamethasone |
Dexamethasone 6 mg used to reduce mortality in covid 19 patients |
| Intervention |
Methylprednisolone |
Methylprednisolone 120 mg for 5 days f/b 60 mg for 3 days f/b 40 mg for 2 days -OD
Methylprednisolone 60 mg for 5 days f/b 40 mg for 5 days is given for the management of COVID 19 patients with ARDS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-75 yrs
2. Adult patients with RTPCR confirmed.
3. Patients with CT Scan features ( CORAD score4 and above)
4. Patients with severe COVID 19 infection whose room air saturation is <93% . |
|
| ExclusionCriteria |
| Details |
1. Patients with multi organ failure , Shock , DIC .
2. Patients with complicated COVID 19 infection .
3. Respiratory failure due to other causes such as head injury , CNS infection , DKA, severe electrolyte disturbances, neuromuscular diseases .
4. Past history of COPD , bronchial asthma .
5. Patients with cardiac disease .
6 . Patients with chronic kidney disease on hemodialysis . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mortality at day 14 and 28
No.of patients requiring invasive ventilation
No. Of icu days and hospital
Incidence of secondary infection |
Mortality at day 14 and 28
No.of patients requiring invasive ventilation
No. Of icu days and hospital
Incidence of secondary infection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of hospital stay
Lower death rate
Decrease in laboratory markers
Lower mortality rate |
28 days |
|
|
Target Sample Size
|
Total Sample Size="291"
Sample Size from India="291"
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 4 |
|
Date of First Enrollment (India)
|
08/12/2021 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We compare the effect of two different doses of methylprednisolone with standard dose of Dexamethasone in patients with severe covid 19 illness |