Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients
Phase 3
- Conditions
- COVID-19.U07.1COVID-19
- Registration Number
- IRCT20200624047908N1
- Lead Sponsor
- Abadan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Age =18
One of the following signs: Fever = 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea
CT appearance compatible with COVID
O2 Saturation 94% or less
Exclusion Criteria
Renal failure (eGFR < 30)
Bradycardia (HR < 50)
Taking amiodarone
Previous sofosbuvir use
Pregnancy/lactation
Multi-organ failure on admission (2 organs or more, excluding lung)
Requiring intubation on admission
Significant arrhythmia in EKG
Allergy to sofosbuvir or daclatasvir
Not consenting to the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery within 10 days of starting the drug. Recovery means: (no fever, no shortness of breath, no cough or improved, no fatigue or improved, tolerated oral nutrition) for 24 hours. Timepoint: Daily. Method of measurement: Clinical observation and examination.
- Secondary Outcome Measures
Name Time Method Recovery within 14 days from start of medication. Timepoint: Daily. Method of measurement: Clinical observation and examination.;Rate of survival. Timepoint: Daily. Method of measurement: census report.;Days admitted in hospital. Timepoint: Daily since hospitalization time. Method of measurement: Based on patient's file.;Days intubated/under ventilator. Timepoint: Daily. Method of measurement: observation.;Days admitted in ICU. Timepoint: Daily. Method of measurement: Based on patient's file.