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Safety and efficacy of sofosbuvir in the moderate COVID19

Phase 3
Conditions
COVID19.
Coronavirus infection, unspecified
U07.1
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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).
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