Trial IRCT20200128046294N2
Publication Sadeghi A, J Antimicrob Chemoth (2020) (published paper)
Dates: 26/03/2020 to 26/04/2020
Funding: Mixed (Fanavaran Rojan Mohaghegh Daru Co.; Digestive Disease Research Institute of Tehran University of Medical Sciences)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Iran
Follow-up duration (days): 30
Inclusion criteria
  • All adult patients aged at least 18 years admitted with suspected COVID-19 infection between 26 March and 26 April 2020 were evaluated for eligibility. Participants were enrolled into the study if they had both positive qualitative RT-PCR on nasopharyngeal swab and chest CT scan compatible with moderate or severe COVID-19 infection. In addition, participants were required to have signs of severity of disease defined as fever (oral temperature ?37.8?C at any one time prior to enrolment) and at least one of respiratory rate >24/min, O2 saturation <94% or PaO2/FiO2 ratio <300 mgHg. Only participants whose onset of symptoms was 8 days or less were included. All patients were required to provide written informed consent prior to participation in the study.
Exclusion criteria
  • A known allergic reaction to the intervention drugs, pregnant or breastfeeding, any prior experimental treatment for COVID-19, heart rate <60 bpm, taking amiodarone, evidence of multiorgan failure, requiring invasive mechanical ventilation at screening and estimated glomerular filtration rate (eGFR) <50mL/1.73 m2/min.
Interventions
Treatment
Sofosbuvir-Daclatasvir
SOF/DCV: 400/60 mg orally once daily for 14 days
Control
Standard care

Participants
Randomized
participants :
Sofosbuvir-Daclatasvir=35
Standard care=35
Characteristics of participants
N= 70
Mean age : NR
34 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Clinical recovery (composite) within 14 days from initiation of study treatment until normalization of fever (/=94% on room air), sustained for at least 24 hours
In the report
Clinical recovery within 14 days of enrolment
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to all available versions of the published article, the study registry was used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved. There is no change from the trial registration in the intervention and control treatments or in the primary and secondary outcomes.