Study to Evaluate the Safety and Efficacy of Sofosbuvir/Daclatasvir in Participants with Moderate to Severe Coronavirus Disease (COVID-19)

Phase 3

Conditions: COVID-19.
COVID-19
U07.1

Registration Number: IRCT20200128046294N2

Lead Sponsor: Digestive Disease Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 70

Inclusion Criteria

Both genders
Age =18 years at time of signing Informed Consent Form
Willing and able to provide written informed consent prior to performing study to any assigned treatment arm
Must agree not to enroll in another study of an investigational agent prior to completion of study
Will be admitted to Shariati hospital (Tehran), Baharloo (Tehran), Sina (Tehran), Sayyad Shirazi (Gorgan) and not transferred to another hospital
Laboratory (RT-PCR) confirmed infection with 2019-nCoV
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% or the Pa02/Fi02 ratio <300mgHg
=8 days since illness onset

Exclusion Criteria

Known allergic reaction to Sofosbuvir or Daclatasvir
Pregnant or breastfeeding, or positive pregnancy test
Receipt of any experimental treatment for COVID-19 prior to the time of the screening evaluation
Heart rate < 60/min
Taking Amiodarone
Evidence of multiorgan failure
Requiring mechanical ventilation at screening
eGFR< 50 mL/min

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical recovery (composite) within 14 days from initiation of study treatment until normalization of fever (=37.2 °C oral), respiratory rate (=24/minute on room air), and oxygen saturation (=94% on room air), sustained for at least 24 hours. Timepoint: daily up to 14 days after starting the trial. Method of measurement: Clinical examination.

Secondary Outcome Measures

Name	Time	Method
Requirement for mechanical ventilation. Timepoint: daily up to day 14. Method of measurement: Clinical evaluation.;Radiological changes. Timepoint: day 14 or sooner at the discretion of the physician. Method of measurement: Chest CT scan.;Serious adverse events. Timepoint: Any time during study up to day 14. Method of measurement: Clinical evaluation.;All-cause mortality. Timepoint: Any time during study up to day 14. Method of measurement: Clinical evaluation.