COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmation of COVID-19 infection within 24 h and positive nasopharyngeal swab for COVID-19 nucleic acid RNA 2. Age =12 years and weight =40 kg 3. Subjects of fertility must agree to use highly effective contraceptive methods
Exclusion criteria
Exclusion criteria: 1. Previous history of COVID-19 treatment 2. A known history of active liver disease 3. Patients on renal dialysis or have moderate to severe impaired renal function 4. The known human immunodeficiency virus (HIV) infection 5. Suspected or confirmed concurrent active systemic infections other than COVID-19 infection 6. Allergy or other contraindication to any component of the study intervention 7. Any drug or substance that is currently or expected to be used that is a high reliance on CYP3A4 enzyme clearance or strong CYP3A4 enzyme inducers 8. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT values (CT values of 40 for negative results) of nasal swab COVID-19 nucleic acid tests on days 4, 7, 9 and 11 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. First negative conversion time (or CT value =40) of COVID-19 nucleic acid tests 2. Hospitalization time, strictly according to discharge criteria 3. Adverse drug reactions recorded during hospitalization 4. COVID-19 nucleic acid re-positive in daily COVID-19 nucleic acid tests in the 7 days of isolation after discharge | — |
Countries
China