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(1) age 16 or older,
(2) inpatient,
(3) positive RT-PCR test for SARS-CoV-2 from a pharyngeal or nasopharyngeal swab specimen collected within 14 days,
(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
(5) able to remain hospitalized for 6 days or longer,
(6) negative pregnancy test (pre-menopausal female only),
(7) written consent for participation
Exclusion criteria(1) performance status of 2 or greater,
(2) severe hepatic disease,
(3) need for dialysis,
(4) altered mental status,
(5) pregnancy,
(6) female patients who do not agree to use effective contraceptive methods,
(7) male patients with female partners who do not agree to the use of effective contraceptive methods,
(8) hereditary xanthinuria,
(9) hypouricemia or history of xanthine urolithiasis,
(10) uncontrolled gout or hyperuricemia,
(11) immunosuppressive conditions,
(12) receipt of systemic antiviral agent against SARS-CoV-2 within 28 days
Interventions
Treatment
Favipiravir
Control
Favipiravir (800 mg)
Duration : 6-10 days
Participants
Randomized
88 participants (n1=44 / n2= 44)
Characteristics of participants
N=88
Mean age : 51.3
46 males
Severity : Mild: n=22 / Moderate: n=62/ 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
available

Protocol

Yes. In language other than English

Statistical plan

Yes

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
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.