Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Daclatasvir and Sofosbuvir: FDC of Daclatasvir (60mg) and Sofosbuvir (400mg)
To be given once a day for 14 days
Intervention2: Ledipasvir and Sofosbuvir: FDC of Ledipasvir (90mg) and S
Sponsors
Pt B D Sharma post graduate institute of medical sciences
Pt B D Sharma post graduate institute of medical sciences
Eligibility
Inclusion 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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDhruva Chaudhry
Pt B D Sharma PGIMS Rohtak
Outcome results
None listed