Re-purposing of Anti HCV drugs for the treatment of COVID-19 diseasr
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027345
- Lead Sponsor
- Pt B D Sharma post graduate institute of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult patients with COVID-19 aged 18 years and above
RT-PCR positive for SARS-CoV-2
Willing to give written informed consent
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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the antiviral efficacy of the investigational products: COVID19 negativity after 7 days of treatmentTimepoint: Baseline, 7 days, 14 days and 28 days
- Secondary Outcome Measures
Name Time Method Assessment of adverse effectsTimepoint: 28 days;Duration of hospitalisationTimepoint: 28 days;Fall in viral load at predefined daysTimepoint: 28 days;MortalityTimepoint: 28 days;Proportion of patients worsening from mild to moderate or moderate to severe class and vice-e-versaTimepoint: 28 days