Trial IRCT20151227025726N14
Publication Tabarsi P, Iran J Pharm Res (2021) (published paper)
Dates: 2020-04-04 to 2020-05-07
Funding: Public/non profit (Shahid Beheshti University of Medical Sciences)
Conflict of interest: *
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Iran Follow-up duration (days): * | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Favipiravir Initial dose: 1600 mg orally twice a day for Day 1 - Maintenance dose: 600 mg orally twice a day on Days 2-7 |
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Control
Lopinavir-Ritonavir 200/50 mg orally twice a day for 7 days | |
Participants | |
Randomized NR Analyzed 62 participants Favipiravir=32 Lopinavir-Ritonavir=30 | |
Characteristics of participants N= 62 Mean age : NR 36 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=62 Critical: n=0 Number of vaccinated participants: 0 | |
Primary outcome | |
In the register Fever, cough, dyspnea | |
In the report Changes in baseline clinical symptoms, including fever, cough, and dyspnea. | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported |
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 was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The trial was registered after the start of recruitment. The authors report that 76 were randomized but only 62 included in analysis due to “non-adherence issues and the occurrence of side effects”. They do not report the number randomized to or excluded from each arm. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. The trial (n = 76) did not achieve its target sample size (n = 84). |