Safety of Sofosbuvir /Daclatasvir in outpatients with COVID-19
Phase 1
Recruiting
- Conditions
- COVID-19.Clinical or epidemiological diagnosis of COVID-19 where laboratory confirmation is inconclusive or not available.U07.2
- Registration Number
- IRCT20200128046294N3
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Both sexes
Age higher than 18 years old
Diagnosis of COVID 19
Patients that do not need to be admitted in hospital
Exclusion Criteria
Patients without consent form
Patients that can not come for follow-up
Pregnancy , breast feeding
Renal insufficiency with eGFR less than 30 , or serum creatinin higher than 2.5 mg/dl in male and 2 mg/dl in female
Heart rate less than 50/ min
Hepatitis B infection
Amiodarone and /or Warfarin consumption
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Related or non -related adverse events. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Daily follow-up.
- Secondary Outcome Measures
Name Time Method Time to clinical recovery. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Clinical Follow-up.;Hospitalization. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Clinical follow-up.;Death. Timepoint: Before intervention and 48 hours after the end of the study (day 12 of study). Method of measurement: Clinical follow-up.