Trial IRCT20200328046886N1
Publication Abbaspour Kasgari H, J Antimicrob Chemoth (2020) (published paper)
Dates: 20/03/2020 to 08/04/2020
Funding: Public/non profit (Mazandaran University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 14
Inclusion criteria
  • Patients with initial symptoms of fever (oral temperature ≥37.8°C at least once before enrolment) and/or cough, shortness of breath and gastrointestinal symptoms were considered to be suspected of having COVID-19. To confirm COVID-19 infection, a positive qualitative RT-PCR for SARS-CoV-2 and/or features consistent with COVID-19 on a chest CT scan was required. Cases of confirmed COVID-19 in the age group of 18 - 80 years were included. Only patients with moderate disease on admission were included, which was defined as respiratory rate of <24/min, arterial O2 saturation of >94% and symptom onset ? 8 days prior to admission, together with compatible findings in a chest CT scan. All patients were required to provide written informed consent prior to participation in the study.
Exclusion criteria
  • Patients with multiorgan failure, active cancer, renal insufficiency (creatine clearance less than 50mL/min/1.73m2), anaemia (haemoglobin less than 9 g/dL), pregnant women or men with a pregnant wife, and patients treated with amiodarone, phenytoin, phenobarbital, rifabutin or carbamazepine
Interventions
Treatment
SOF/DCV+RBV
Sofosbuvir/daclatasvir: 400/60 mg orally once a day Ribavirin: 600 mg twice a day
Control
Standard care

Participants
Randomized
participants :
SOF/DCV+RBV=24
Standard care=24
Characteristics of participants
N= 48
Mean age : NR
18 males
Severity : Mild: n=0 / Moderate: n=48 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Clinical recovery (composite) within 14 days from initiation of study treatment did not need for ICU ,invasive and non invasive mechanical ventilation ,the time for eradication of virus from upper respiratory tract by RT-PCR test
In the report
Length of hospital stay
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 study achieved the target sample size specified in the registry. There is no change from the trial registration in the intervention and control treatments. The trial registration specified 'main outcome variables' as opposed to 'primary outcome' and 'secondary outcome' as specified in the published report. The primary outcome in the report was not listed among the 'main outcome variables'. There are no secondary outcomes specified in the registry