COVID-19. COVID-19 confirmed by laboratory testing
Conditions
Interventions
Intervention 1: Intervention group: A single daily tablet containing sofosbuvir 400mg and daclatasvir 60mg (Sovodak, Fanavaran Rojan Mohaghegh Daru Co., Tehran, Iran) for 10 days. Intervention 2: Cont
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients (=18 years) Onset of any one of the following symptoms within 7 days before presentation: fever, cough, chest discomfort, dyspnea, loss of taste or smell, severe body aches, weakness or fatigue Laboratory-confirmed SARS-CoV-2 infection by qualitative Reverse transcription polymerase chain reaction (RT-PCR) Able to provide written, informed consent Able to comply with study protocol for follow-up Not requiring hospitalization at the time of recruitment
Exclusion criteria
Exclusion criteria: Personal history of COVID-19 Pregnancy or breastfeeding Known severe chronic kidney disease requiring dialysis or eGFR <30 Taking medications that interfere with trial drugs including amiodarone or warfarin Heart rate <50 / min Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the two treatment arms in the proportion of participants classed as treatment failure at 14 days from enrolment. Treatment failure is defined as need for hospital admission or all-cause mortality within 14 days. Need for hospital admission is defined as the decision of a physician to admit the patient to a hospital according to current national COVID-19 guidelines issued by the ministry of health. However, if the participant leaves the hospital against medical advice, it will still be considered a treatment failure. Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to hospitalization (days from enrolment). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up.;Duration of hospital stay (days). Timepoint: One month after enrolment. Method of measurement: Clinical follow-up.;Need for ICU stay according to hospital records (yes/no). Timepoint: One month after enrolment. Method of measurement: Clinical follow-up.;Need of mechanical ventilation according to hospital records (yes/no). Timepoint: One month after enrolment. Method of measurement: Clinical follow-up.;Time to complete symptom resolution [patient becomes asymptomatic] from start of treatment (days from enrolment). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up.;Hospital ER visit at the discretion of the patient (yes/no). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up.;Adverse drug effects (yes/no). Timepoint: 14 days after enrolment. Method of measurement: Clinical follow-up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Ali Asgari
Tehran University of Medical Sciences
Outcome results
None listed