Trial IRCT20200328046882N1
Publication Alavi-moghaddam M, SSRN, 2021 (preprint)
Dates: 2020-04-01 to 2020-09-30
Funding: Public/non profit (Deputy of Research in Shahid Beheshti University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / Iran Follow-up duration (days): 14 | |
| Inclusion criteria | 18-75 years old; chest computerized tomography (CT) findings suggestive of pulmonary infection by COVID-19; fever (temperature: ≥36.6 °C armpit or ≥ 37.2 °C oral or ≥37.8 °C rectal); physical finding concluding of respiratory infection (rales/crackles or decreased respiratory sounds plus ego phony or increased tactile fremitus or vocal fremitus); oxygen Saturation of 93% or lower (at room air); positive report of RT-PCR-COVID-19 RNA by a distinguished national diagnostic laboratory |
| Exclusion criteria | Participation in any other clinical trial; evidence of multi-organ failure; creatinine clearance <30 ml/min; need for mechanical ventilation at screening; pregnant or breast-feeding women; positive HIV or HCV or HBV tests; allergy to Sofosbuvir |
| Interventions | |
| Treatment
Sofosbuvir 400 mg orally once daily until recovery for at least 3 days |
|
| Control
Lopinavir-Ritonavir+Interferon beta-1a ( / ) | |
| Participants | |
| Randomized 57 participants (n1=27 / n2= 30) | |
| Characteristics of participants N=57 Mean age : NR 38 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=57 Critical: n=0 | |
| Primary outcome | |
| In the register Normalization of fever( ≤37.2 °C oral, or ≤36.6 °C armpit, or ≤37.8 °C rectal AND oxygen saturation (≥94% on room air), sustained for at least 72 hours within 14 days from initiation of trial | |
| In the report Clinical recovery by normal body temperature (≤37.2°C oral, or 36.6°C armpit, or 37.8°C rectal) and normal oxygen saturation rate (≥94% on room air), sustained for 72 hours since initiation of antiviral treatment | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Unclear |
| 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 pre-print article, the study registry was used in data extraction and risk of bias assessment. Neither study protocol nor statistical analysis plan was available. The study nearly achieved the target sample size specified in the trial registry (60 specified, 57 enrolled). The comparison in the registry was Sofosbuvir for 5 days versus 10 days, whereas in the report the comparison is Sofosbuvir 400 mg single dose daily versus Interferon-beta-1a plus Lopinavir /ritonavir until clinical recovery. Described as double-blinded (patients, investigators, outcome assessor) in the registry, but report states that patients were not blinded. |