| CTRI Number |
CTRI/2021/05/033742 [Registered on: 24/05/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to know the efficacy of REMDESIVIR, an antiviral drug in treating Moderate and severe Covid – 19 Pneumonia (Lung Infection) due to CORONA virus in adult patients. |
|
Scientific Title of Study
|
A Retrospective study of Comparing outcomes of Moderate and severe COVID-19 Pneumonia in patients treated with guideline based remdesivir regimen and non-remdesivir regimen†RESCUER study |
| Trial Acronym |
RESCUER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Duraisamy Kathirvel |
| Designation |
Assistant professor of Cardiology |
| Affiliation |
Government Villupuram Medical College and Hospital |
| Address |
OP no: 307,
Department of Cardiology,
Government Villupuram Medical College and Hospital,
Mundiyampakkam.
Villupuram
19/3, VDM main road,
Mangalampet,
Cuddalore district
606104
Cuddalore
TAMIL NADU
605601
India |
| Phone |
9943375533 |
| Fax |
|
| Email |
maestrokathir@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Duraisamy Kathirvel |
| Designation |
Assistant professor of Cardiology |
| Affiliation |
Government Villupuram Medical College and Hospital |
| Address |
OP no: 307,
Department of Cardiology,
Government Villupuram Medical College and Hospital,
Mundiyampakkam.
Villupuram
19/3, VDM main road,
Mangalampet,
Cuddalore district
606104
Cuddalore
TAMIL NADU
605601
India |
| Phone |
9943375533 |
| Fax |
|
| Email |
maestrokathir@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Duraisamy Kathirvel |
| Designation |
Assistant professor of Cardiology |
| Affiliation |
Government Villupuram Medical College and Hospital |
| Address |
OP no 307,
Department of Cardiology,
Government Villupuram Medical College and Hospital,
Mundiyampakkam.
Villupuram.
19/3, VDM main road,
Mangalampet,
Cuddalore district
606104
Cuddalore
TAMIL NADU
605601
India |
| Phone |
9943375533 |
| Fax |
|
| Email |
maestrokathir@yahoo.com |
|
|
Source of Monetary or Material Support
|
| THE DEAN,
Government villupuram Medical college and Hospital,
Mundiyampakkam,
Villupuram. |
|
|
Primary Sponsor
|
| Name |
Government of Tamilnadu |
| Address |
NH road,
Mundiyampakkam,
Villupuram. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DURAISAMY KATHIRVEL |
Government Villupuram Medical College and Hospital |
OP no 307,
Department of Cardiology,
Government Villupuram Medical College and Hospital,
Mundiyampakkam.
Villupuram.
Viluppuram
TAMIL NADU |
09943375533
maestrokathir@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Villupuram Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
REMDESIVIR |
Remdesivir, usullay administered as injection at a loading dose of 200mg intravenously on Day 1 over 30 - 120 min, followed by 100mg for another 4 days for covid -19 pneumonia patients.
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age ≥12 years with Confirmed COVID-19. (Laboratory (RT-PCR) – Positive)
Moderate COVID pneumonia:
Moderate Pneumonia (frequent fever, cough) with no obvious hypoxemia, chest CT with lesions.
Severe COVID pneumonia:
Severe Pneumonia with hypoxemia (SpO2 < 92%).
Patients received Remdesivir (Case) and also not received it (Control group).
|
|
| ExclusionCriteria |
| Details |
Mild infection (without CT lesions)
Critical pneumonias (CT involvement > 75%).
Patients with moderate and Severe pneumonia but died within 3 days of hospital admission.
Patient who received Tocilizumab (critical pts)
Severe liver disease (AST > 5 times upper limit)
Patients with severe renal impairment (estimated GFR ≤30 mL/min/1.73 m2) or receiving continuous Dialysis
Pregnant or breastfeeding mothers.
Patient transferred to another hospital within 72 hours.
Cases with inadequate datas.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time to clinical recovery
2. All cause mortality
|
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of invasive mechanical ventilation
2. Duration of noninvasive ventilation or use of high-flow Nasal oxygen devices (HFNO);
3. Duration of low-flow supplemental oxygen;
4. Any Complications (Drug or disease related),
5. Length of hospital stay (days)
|
One month
|
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
27/05/2021 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Remdesivir is a nucleotide analogue which inhibits viral RNA polymerases, is the best prospect among currently available antivirals against SARS-CoV-2 virus. It is effective in viral replication phase than in immune dysregulation phase of COVID-19 infection. Hence, patients received this drug in the appropriate phase will have benefit. Results of the study will give inputs to the efficacy and side effects of this drug. Even though the level of Evidence for retrospective study is III, when compare the randomised prospective study, results of this study will have and impact in the future use of this drug Remdesivir in COVID-19 pneumonia. |