The effectiveness of Sovodak (sofosbuvir+daclatasvir) in Covid-19 patients
Phase 3
- Conditions
- The effectiveness of Sovodak in patients with novel Corona Virus.ICD-10 code of ‘U07.1 COVID-19, virus identified’ is assigned to a disease diagnosis of COVID-19 confirmed by laboratory testing.U07.1 COVI
- Registration Number
- IRCT20200328046886N1
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
patients with signing Informed Consent Form Willing
Age 18-65 years old
Laboratory (RT-PCR) confirmed infection with 2019-nCoV or Lung involvement confirmed with chest CT scan
Hospitalized patients with Fever (Oral temperature = 37.8 ?) and at least one of Respiratory rate<24/min / O2Sat>94%
=8 days since illness onset
Exclusion Criteria
Known allergic reaction to Sofosbuvir or Daclatasvir
Pregnant or breastfeeding women
Taking Amiodarone
Evidence of multiorgan failure
Requiring mechanical ventilation at screening
eGFR< 50 mL/min
Taking enzyme inducer like Rifampin
Receipt of any experimental treatment for COVID-19 prior to the time of the screening
Patient with Hb<9
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed of invasive and non invasive mechanical ventilation ,need of oxygen supplement , the median time for recovery and well-being. Timepoint: daily in all duration of study. Method of measurement: By designed investigator checklist.
- Secondary Outcome Measures
Name Time Method