FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027345 [Registered on: 24/08/2020] Trial Registered Prospectively
Last Modified On: 24/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Re-purposing of Anti HCV drugs for the treatment of COVID-19 diseasr 
Scientific Title of Study   Selection and Prioritization of Antiviral Drugs used for Hepatitis C Virus (HCV) and evaluation of their efficacy and safety in COVID- 19 Patients: A Rational target- based Pilot Repurposing Trial 
Trial Acronym  SPARTACOS-19 trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhruva Chaudhry 
Designation  Senior professor 
Affiliation  Pt B D Sharma PGIMS Rohtak 
Address  Head of Department Dept of Pul and Crit Care Medicine Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  dhruvachaudhry@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dhruva Chaudhry 
Designation  Senior professor 
Affiliation  Pt B D Sharma PGIMS Rohtak 
Address  Head of Department Dept of Pul and Crit Care Medicine Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  dhruvachaudhry@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dhruva Chaudhry 
Designation  Senior professor 
Affiliation  Pt B D Sharma PGIMS Rohtak 
Address  Head of Department Dept of Pul and Crit Care Medicine Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  dhruvachaudhry@yahoo.co.in  
 
Source of Monetary or Material Support  
The Director (intramural Grant) Pt B D Sharma Post Graduate Institute of Medical Sciences. Medical Mod, Rohtak Haryana-124001  
 
Primary Sponsor  
Name  Pt B D Sharma post graduate institute of medical sciences 
Address  Pt B D Sharma PGIMS Rohtak 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Pt B D Sharma post graduate institute of medical sciences  Pt B D Sharma PGIMS Rohtak 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhruva Chaudhry  Pt BDS PGIMS Rohtak  Ward Number Trauma Triage and Trauma Ward Floor 3 DATC Building Department of Pul and Crit Care Medicine Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA 
9991101616

dhruvachaudhry@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PGIMS/UHS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Daclatasvir and Sofosbuvir  FDC of Daclatasvir (60mg) and Sofosbuvir (400mg) To be given once a day for 14 days  
Intervention  Ledipasvir and Sofosbuvir  FDC of Ledipasvir (90mg) and Sofosbuvir (400mg) to be given once a day for 14 days 
Comparator Agent  Standard of care  standard of care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult patients with COVID-19 aged 18 years and above
RT-PCR positive for SARS-CoV-2
Willing to give written informed consent
 
 
ExclusionCriteria 
Details  Pregnancy or breast feeding
Hepatic cirrhosis
Alanine aminotransferase or aspartate aminotransferase more than five times the upper limit of normal
Known severe renal impairment (estimated glomerular filtration rate <30 mL/min per 1·73 m2) or receipt of continuous renal replacement therapy, haemodialysis, or peritoneal dialysis
Enrolment into an investigational treatment study for COVID-19 in the 30 days before screening
Patients of child-bearing age (men and women) not agreeing to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 7 days after the last study drug administration
Any known hypersensitivity to the study drugs
Any patient belonging to Severe class of COVID19 disease as per GOI guidelines (MoHFW) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the antiviral efficacy of the investigational products: COVID19 negativity after 7 days of treatment  Baseline, 7 days, 14 days and 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Fall in viral load at predefined days  28 days 
Duration of hospitalisation  28 days 
Proportion of patients worsening from mild to moderate or moderate to severe class and vice-e-versa  28 days 
Mortality  28 days 
Assessment of adverse effects  28 days 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
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)   31/08/2020 
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   NIL 
Brief Summary  

Study design

This will be an investigator-initiated, parallel group, open-label, individually randomized, controlled clinical study. It will be conducted by Pt. B.D. Sharma Postgraduate Institute of Medical Sciences, Rohtak (Haryana). All the study procedures will be carried out under the supervision of the expert clinician. This pilot study is being undertaken to assess the efficacy and safety of oral Fixed Dose Combinations (FDCs) of Ledipasvir/Daclatasvir with Sofosbuvir; in adults (aged ≥18 years) with SARS-CoV-2 /COVID-19 infection admitted at PGIMS, Rohtak.The study will be done in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization–Good Clinical Practice guidelines. The local and National guidelines for taking care of the COVID- patients will be followed.

Patients

Eligible patient will be recruited in the study as per the following inclusion and exclusion criteria

Inclusion Criteria

    Adult patients with COVID-19 aged 18 years and above;

    RT-PCR positive for SARS-CoV-2;

    Willing to give written informed consent.

Exclusion criteria

    Pregnancy or breast feeding;

    Hepatic cirrhosis;

    Alanine aminotransferase or aspartate aminotransferase more than five times the upper limit of normal;

    Known severe renal impairment (estimated glomerular filtration rate <30 mL/min per 1·73 m2) or receipt of continuous renal replacement therapy, haemodialysis, or peritoneal dialysis;

    Enrolment into an investigational treatment study for COVID-19 in the 30 days before screening.

    Patients of child-bearing age (men and women) not agreeing to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 7 days after the last study drug administration.

    Any known hypersensitivity to the study drugs.

    Any patient belonging to Severe class of COVID19 disease as per GOI guidelines (MoHFW)

 

Study Procedure

a)      The enrolled patient selected as per the above inclusion and exclusion criteria will be given detailed information about the purpose of the study and will be provided with the patient information sheet, explaining the study procedures, risks, benefits, responsibilities etc. After ensuring that the patient has understood about the details of the study, a written informed consent will be obtained from each of the patients or their legal representatives if they are unable to provide consent.

b)      All the patients enrolled for the study will be subjected to relevant clinical and laboratory examination and their demographic details and baseline parameters will be recorded as per case record form.

 

Study Treatment

One hundered seventy five eligible patients will be randomly allocated (web based randomization number generator), to one of the following three study groups in the ratio of 1:2:2 (n= 35, 70, 70) .

 

Group I: Standard treatment as per hospital/MoHFW protocol

Group II- FDC of Ledipasvir (90mg) and Sofosbuvir (400mg) + Treatment as per hospital/MoHFW protocol for 14 days

Group III- FDC of Daclatasvir (60mg) and Sofosbuvir (400mg) + Treatment as per hospital/MoHFW protocol for 14 days

Efficacy Assessment: All the patients will be actively assessed for various parameters of efficacy at the baseline and for the study drug response at various intervals for 14days and will be followed up for 30 days thereafter.

Viral positivity in naso- and oro-pharyngeal samples will be tested on day 3, 7 and 14, both in qualitative and quantitative forms.

Sample size calculation

For sample size calculation, it was known that 20% of patients of COVID19 with mild severity become negative on day 7 whereas the incidence of negative RT-PCR on day 7 in the intervention group was assumed to be 50%. Making an estimated hazard ratio of 2.5. We planned to enroll subjects in a ratio of 1:2:2 in three groups (2 in intervention group for which there were two groups and one for standard of care group). For final analysis of negative RT PCR on day 7, we calculated that a total number of 145 patients will provide 80% power to detect a hazard radio of 2.5 at a two sided significance level of 0.05. Assuming an attrition rate of 20%, we planned to recruit 175 cases for the trial with 35 subjects in the control group and 70 patients in each intervention group.

Clinical and Laboratory Monitoring

Clinical findings including history and physical examination, and laboratory and radiological investigation results will be entered into a predesigned case record form. Chest radiograph and ECG will be taken at baseline and at regular intervals for monitoring of patient’s progress and to detect early cardiac rhythm changes. Patients with underlying cardiac conditions will be put on cardiac monitoring. All patients will be followed up till 30 days after discharge. Initial diagnosis of SARS-CoV-2 infection will be made upon admission. Complete blood count, liver and renal function tests, lactate dehydrogenase, creatine kinase, C-reactive protein, and erythrocyte sedimentation rate will be regularly checked until discharge. Virological measures will include the proportions of patients with viral RNA detected and viral RNA load (measured by quantitative RT-PCR).

Safety outcomes

    Treatment-emergent adverse events;

    Serious adverse events;

    Premature discontinuations of study drugs.


 
Close