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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  
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 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  
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 
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 .
 
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