Safety and efficacy of sofosbuvir in the moderate COVID19
- Conditions
- COVID19.Coronavirus infection, unspecifiedU07.1
- Registration Number
- IRCT20180302038915N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Both genders Age ranging from18 to 80 Y.O. who are admitted in hospital
showing at least one of these criteria: Fever (Oral temperature = 38 ?) , Respiratory rate >24/min , O2Sat<93% in room air or the Pa02/Fi02 ratio =300mgHg
Laboratory (RT-PCR) confirming the infection with 2019-Covid Virus
Lung involvement in CT-Scan less than 50 % ( in compliance with the involvement of moderate COVID19 )
5 =days since onset of the COVID19 symptoms =10
History of allergic reaction to the drugs used in this clinical trial
in a pregnancy or breast feeding status
test Receipt of any experimental treatment for COVID-19 before hand
Heart rate < 60/min
currently on amiodarone prescription
presence of multi organ failure evidence
in need of mechanical ventilation
estimated glomerular filtration rate < 50 0mL/1.73 m2/min
admitted in ICU ward
who are in shock
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to reach clinical recovery. Timepoint: after 10 days on treatment initiation. Method of measurement: daily physical exam, assessing vanishing of tachypnea ,blood saturation of O2(using pulse-oximeter) , fever( using thermometer).
- Secondary Outcome Measures
Name Time Method The rate of patients who need to admit in ICU ward. Timepoint: 14 days after Treatment initiation. Method of measurement: physical exam and paraclinical evaluation.;The rate of patient expiry in each arm. Timepoint: 14 days after treatment initiation. Method of measurement: questionnaire.;Remission of clinical symptoms in each arm. Timepoint: 14 days after treatment initiation. Method of measurement: physical exam ( thermometer and pulse-oximeter).