Trial jRCTs041190120
Publication Doi Y, Antimicrob Agents Ch (2020) (published paper)
Dates: 2020-03-02 to 2020-05-18
Funding: Mixed (Japan Agency for Medical Research and Development (AMED), favipiravir was donated by FUJIFILM Toyama Chemical)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Japan Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Favipiravir Early |
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Control
Favipiravir Late | |
Participants | |
Randomized participants : Favipiravir Early=44 Favipiravir Late=45 | |
Characteristics of participants N= 89 Mean age : NR 54 males Severity : Mild: n=20 / Moderate: n=65 / Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Proportion of subjects with clearance of SARS-CoV2 in nasopharyngeal swab by Day 6 | |
In the report Time to SARS-CoV-2 clearance and presence or absence of SARS-CoV-2 clearance by RT-PCR of nasopharyngeal specimens by day 6 | |
Documents avalaible |
Protocol Yes. In language other than English Statistical plan Yes 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 manuscript accepted for publication, the study registry was used in data extraction and risk of bias assessment. The trial registration provides extensive detailed information about study design, conduct, results and administrative matters. Study protocol, analysis plan and consent documents in Japanese are available through the registry. There is no change from the trial registration in outcomes or in intervention and control treatments. Adverse events and serious adverse events were not reported per intervention group. |