Trial IRCT20200328046885N1
Publication Yadollahzadeh M, Research square , 2021 (preprint)
Dates: 2020-08-19 to 2020-09-19
Funding: Public/non profit (Iran University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT | |
| Location :
Single center / Iran Follow-up duration (days): 20 | |
| Inclusion criteria | Age more than 18; hospitalized patients; respiratory symptom and SaO2 >90; diagnostic chest CT scan (mild to moderate scores); with or without Temperature >38 |
| Exclusion criteria | Hypersensitivity to the drug; pregnant or breastfeeding; using other COVID-19 related drugs; heart rate <60/min; having organ failure; eGFR< 50 mL/min; decreased level of consciousness; blood pressure less than 90/60 mm Hg; hypoxia; blood oxygen saturation less than 90%; allergies to study drugs; prior COVID-19 treatment; organ failure; requiring mechanical ventilation at the time of hospitalization; patients with adverse reaction drugs |
| Interventions | |
| Treatment
Sofosbuvir-Daclatasvir SOF/DCV: 400/60 mg orally once daily for 5-7 days |
|
| Control
Lopinavir-Ritonavir ( / ) | |
| Participants | |
| Randomized 112 participants (n1=* / n2= *) | |
| Characteristics of participants N=112 Mean age : NR 50 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Death (14,3,2,1,0 days after the start of the intervention), Recovery and discharge from the hospital (End of treatment) | |
| In the report The clinical recovery analyzed the main outcome in 5 to 7 days by normalization of fever (≤37.2 °C), respiratory rate (≤24/minute), and oxygen saturation (≥94%). | |
| 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 |
High |
| General comment | In addition to the pre-print article, the retrospective trial registry was used in data extraction and risk of bias assessment. The study protocol or statistical analysis plan was not available at the time of data extraction. The registry lists two recruitment centers affiliated to the same university but the report mentions only one. Some outcomes described in the registry (receipt of 4 drugs during treatment) and the report (clinical recovery) were not reported. The study did not achieve its target sample size. |