| CTRI Number |
CTRI/2020/12/029894 [Registered on: 18/12/2020] Trial Registered Prospectively |
| Last Modified On: |
17/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effectiveness of two drugs, Dexamethasone versus Methylprednisolone in the treatment of moderate Covid 19 patients |
|
Scientific Title of Study
|
Comparing the effectiveness of Dexamethasone versus Methylprednisolone in patients with moderate Covid 19 - A Randomised controlled trial |
| Trial Acronym |
DMC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR R Nivetha |
| Designation |
Post Graduate General Medicine |
| Affiliation |
SRM Medical College Hospital and Research centre |
| Address |
Department of General Medicine
1st floor
SRM Medical College Hospital and Research Centre
SRM University
Potheri
Kattankulathur
Department of General Medicine
1st floor
SRM Medical College Hospital and Research Centre
SRM University
Potheri
Kattankulathur
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7338929167 |
| Fax |
|
| Email |
nivethamdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T A Vidya |
| Designation |
Associate Professor General Medicine |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of General Medicine
1st floor
SRM Medical College Hospital and Research Centre
SRM University
Potheri, Kattankulathur
Chengalpet District
Department of General Medicine
1st floor
SRM Medical College Hospital and Research Centre
SRM University
Potheri, Kattankulathur
Chengalpet District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9790911898 |
| Fax |
|
| Email |
tavidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR R Nivetha |
| Designation |
Post Graduate General Medicine |
| Affiliation |
SRM Medical College Hospital and Research centre |
| Address |
Department of General Medicine
1st floor
SRM Medical College Hospital and Research centre
SRM University
Potheri
Kattankulathur
Department of General Medicine
1st floor
SRM Medical College Hospital and Research centre
SRM University
Potheri
Kattankulathur
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7338929167 |
| Fax |
|
| Email |
nivethamdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre
SRM University
Potheri
Chengalpet district
603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre
SRM University
Potheri, Kattankulathur
Chengalpet district
603203 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR R Nivetha |
Department of General Medicine 1st floor
SRM Medical College Hospital and Research Centre
SRM University
Potheri, Kattankulathur
Chengalpet District
603203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K T Jayakumar |
SRM Medical college Hospital and Research centre |
Covid ward
1st floor and 2nd floor
Kancheepuram
TAMIL NADU |
9840551610
jayakumarkt31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTE 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 |
| Intervention |
Dexamethasone |
Inj Dexamethasone 6mg/8mg IV OD X 7 Days |
| Comparator Agent |
Methylprednisolone |
Inj Methylprednisolone 32mg/60mg IV OD X 6Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Hospitalized patients with moderate SARS-COV-2 infection laboratory confirmed by RT-PCR
(Moderate COVID 19- SPO2 <94% Under room air and requiring supplemental oxygen for hypoxemia
Respiratory rate 24-30/min
NLR >5
CRP 50-100 mg/l
Serum ferritin 600-1500 ng/ml
Serum LDH 300-500 IU/l
D Dimer 0.5-1.0 mic/ml
IL-6 20-100 pg/ml
CT chest showing 25-75% infiltrates)
|
|
| ExclusionCriteria |
| Details |
1.Patients with mild and severe covid pneumonia
2.Patients who are already on steroid treatment for any underlying condition
3.Patients already started on antivirals
4.Pregnant or lactating women
5.Any known contraindication to short term corticosteroid like severe immunosuppression, HIV infection or any other immunosuppressant usage
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|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality during hospital stay |
Day 1 - Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time taken to wean off supplemental oxygen
2.Need for mechanical ventilation |
Day 1 of enrollment in the study to Day 7 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/12/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study will be published after completion in a peer reviewed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to compare and explore the effectiveness of dexamethasone versus methylprednisolone in the treatment of novel corona virus pneumonia and to identify effective steroid treatment that may be beneficial to improve clinical outcome for hospitalised covid 19 patients in the future. This is a randomised controlled trial. Patients who fulfill the inclusion and exclusion criteria from covid ward in SRM Medical college hospital and research centre will be included in the study. After obtaining informed consent, patients with moderate covid 19 infection will be grouped into two categories, group A and group B randomly in the ratio of 1:1 using computer generated randomisation sequence. Block randomisation with a block size of 10 will be used. Group A will receive Inj Dexamethasone 6mg or 8mg IV OD for 7 days and group B will receive Inj Methylprednisolone (in equivalent dose to dexamethasone) IV OD for 7 days. 1.5mg of dexamethasone is equal to 8mg of methylprednisolone. During the duration of seven days, regular clinical assessment for improving or deteriorating signs and symptoms will be assessed. At the end of the study on day 7, patient will be assessed both clinically and lab wise and outcome will be measured. If the duration of hospital stay is prolonged for more than 7 days, then final clinical and indicated lab assessment will be done on the day of discharge. Descriptive statistics will be done for all data and suitable statistical tests of comparison will be done. P value < 0.05 considered as significant. Data will be analysed using SPSS version 20.0
|