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
Sofosbuvir-Daclatasvir+Ribavirin Sofosbuvir/daclatasvir: 400/60 mg orally once a day Ribavirin: 600 mg twice a day |
|
Control
Standard care Definition of Standard care: * | |
Participants | |
Randomized 48 participants (n1=24 / n2= 24) | |
Characteristics of participants N=48 Mean age : NR 18 males Severity : Mild: n=0 / Moderate: n=48/ Severe: n=0 Critical: n=0 | |
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 stated Yes |
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 |