Trial IRCT20200624047908N1
Publication Mobarak S, J Antimicrob Chemoth, 2021 (published paper)
Dates: 2020-07-13 to 2020-10-30
Funding: Public/non profit (International Treatment Preparedness coalition)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / Iran Follow-up duration (days): 28 | |
| Inclusion criteria | Clinically diagnosed COVID-19 by either PCR positivity or COVID-19 compatible lung chest CT scan findings ; More than 18 years old ; Written informed consent ; Any one of fever (oral temperature ≥ 37.8 °C), dry cough, severe fatigue, dyspnea, and oxygen saturation <95%. |
| Exclusion criteria | Renal failure; Pregnant or breastfeeding; Multi-organ failure or required intubation on admission; Significant arrhythmias; On amiodarone; Previous sofosbuvir use for current infection; Allergic to sofosbuvir/daclatasvir; Enrolled in other interventional trials |
| Interventions | |
| Treatment
Sofosbuvir-Daclatasvir SOF/DCV: 400/60 mg orally once daily for 10 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 1083 participants (n1=541 / n2= 542) | |
| Characteristics of participants N=1083 Mean age : NR 585 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=2 | |
| Primary outcome | |
| In the register Recovery within 10 days of starting the drug. Recovery means: (no fever, no shortness of breath, no cough or improved, no fatigue or improved, tolerated oral nutrition) for 24 hours. | |
| In the report Hospital discharge within 10 days after randomization where participants were discharged on the managing physician’s decision based on the absence of fever or dyspnoea, no or improved cough and fatigue, and tolerance of oral feeding, with a stable O2 saturation of >=95%. | |
| 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 the published artcile, the pre-print article and the trial registry were used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were no differences between the published/pre-print article and trial registry in population, procedures and interventions. The published article reports on changes to the protocol during the study. These included broadening the inclusion criteria to allow more participants to be recruited, amending the discharge criteria and dropping the ICU outcome due to shortages of hospital beds. Admission to and length of stay in ICU, a secondary outcome in the registry, was not measured because of lack of ICU beds. The report methods state that adverse events were recorded but these were not reported. The trial achieved its pre-stated target sample size. The study was updated on December 16th, 2021 with data from the published article.. |