CTRI Number |
CTRI/2020/06/025760 [Registered on: 09/06/2020] Trial Registered Prospectively |
Last Modified On: |
09/06/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Single Arm Study |
Public Title of Study
|
A clinical trial to study the effect of drug named Sofosbuvir in hospitalized patients with COVID 19. |
Scientific Title of Study
|
Efficacy of Sofosbuvir in the management of hospitalized COVID 19 patients. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Babu N |
Designation |
Director Department of critical care |
Affiliation |
Vijaya Medical and Educational Trust |
Address |
B9IRIS, TIVOLI GARDENS,
Old no. 3, New no. 51,
Vadapalani,
Chennai. Vijaya Medical and Educational Trust, No 434, old no 180, N.S.K salai, Vadapalani, Chennai 600026 Chennai TAMIL NADU 600026 India |
Phone |
7299252827 |
Fax |
|
Email |
drbabunarayan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Babu N |
Designation |
Director Department of critical care |
Affiliation |
Vijaya Medical and Educational Trust |
Address |
B9IRIS, TIVOLI GARDENS,
Old no. 3, New no. 51,
Vadapalani,
Chennai. Vijaya Medical and Educational Trust, No 434, old no 180, N.S.K salai, Vadapalani, Chennai 600026 Chennai TAMIL NADU 600026 India |
Phone |
7299252827 |
Fax |
|
Email |
drbabunarayan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Babu N |
Designation |
Director Department of critical care |
Affiliation |
Vijaya Medical and Educational Trust |
Address |
B9IRIS, TIVOLI GARDENS,
Old no. 3, New no. 51,
Vadapalani,
Chennai. Vijaya Medical and Educational Trust, No 434, old no 180, N.S.K salai, Vadapalani, Chennai 600026 Chennai TAMIL NADU 600026 India |
Phone |
7299252827 |
Fax |
|
Email |
drbabunarayan@gmail.com |
|
Source of Monetary or Material Support
|
vijaya medical and education trust |
|
Primary Sponsor
|
Name |
Dr N Babu |
Address |
Vijaya Medical and Educational Trust No 434 old no 180 N.S.K Salai Vadapalani Chennai 600026. |
Type of Sponsor |
Other [self funding] |
|
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 N Babu |
Vijaya Medical and Educational Trust |
Vijaya Medical and Educational Trust No 434 old no 180 N.S.K salai Vadapalani Chennai 600026 Chennai TAMIL NADU |
7299252827
drbabunarayan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee- Vijaya Institute of Clinical and Medical Research |
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 |
Drug sofosbuvir |
sofosbuvir 400 mg twice daily for 10 days in all eligible study subjects along with standard of care including tablet hydroxy chloroquine 400 mg twice a day on day 1 followed by 200 mg twice a day upto day 5. |
Comparator Agent |
nil |
nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
Patients more than 18 years of age and proven COVID-19 by RT-PCR for SARS CoV-2 with one of the following criteria
1. requiring hospitalization with acute organ dysfunction(or)
2. SaO2 in room air <93% or need for supplemental oxygen support in any form(or)
3. Infiltrates in Chest X rays or CT Chest or Ultrasound evidence of Pneumonia and
|
|
ExclusionCriteria |
Details |
1. Patients with mild symptoms (only fever and cough) and no risk factors
2. Or not requiring any hospitalization,
3. patient with comorbid illnesses with less than 50% survival rate at 1 year (Chronic End Stage Organ Disease).
4. Patient on dialysis or Chronic kidney disease stage 5
5. Patient on drugs: amiodarone, phenytoin, phenobarbital and rifampicin
6.Patient with HBsAg (or) anti Hbc Antibody Positive
7.Patient with anti HCV antibody positive
8.Patient not willing to give consent.
9. Pregnancy/ lactating women
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
mortality of the study subjects |
during hospitalisation |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.number of hospitalisation days
2.number of intensive care unit days
3.need for invasive ventilation.
4.number of ventilator days.
5.period of viral clearance |
during hospitalisation |
|
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
|
Phase 3 |
Date of First Enrollment (India)
|
17/06/2020 |
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="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil at present
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Non-randomized, interventional study (open labeled-non blinded) single arm trial- Efficacy of Sofosbuvir in COVID-19 patients requiring hospitalization. The primary outcome - mortality. The secondary outcomes - number of hospitalization days , ventilator days, need for invasive ventilation treatment and days for the viral clearance . |