Trial IRCT20200506047323N3
Publication Hassaniazad M, J Med Virol (2022) (published paper)
Funding: Public/non profit (Hormozgan University of Medical Sciences )
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Iran Follow-up duration (days): 14 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Favipiravir Initial dose: 1600 mg orally twice on day 1 - Maintenance dose: 600 mg orally twice a day on days 2-5 |
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Control
Lopinavir-Ritonavir 200/50 mg orally twice a day for 7 days | |
Participants | |
Randomized participants : Favipiravir=33 Lopinavir-Ritonavir=33 | |
Characteristics of participants N= 66 Mean age : NR 36 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=63 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Viral load. Body temperature. Oxygen saturation. Before intervention and day 7 after the intervention. | |
In the report Viral clearance of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization. SpO2 (after 5 min discontinuation of supplemental oxygen), body temperature (temperature), and RR. | |
Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing willing stated in the publication: 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 article, the trial registry, protocol and supplementary appendices were used in data extraction and assessment of risk of bias. A complete non-English protocol was also available. There is no change from the trial registration in the intervention and control treatments. The primary outcomes in the article reflect those in the registry and protocol. The trial (n = 66) achieved its target sample size (n = 64). |