Trial JapicCTI-205238
Publication Shinkai M, Infect Dis Ther, 2021 (published paper)
Dates: 2020-04-02 to 2020-08-16
Funding: Private (FUJIFILM Toyama Chemical Co., Ltd. )
Conflict of interest: Yes
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Multicenter / Japan Follow-up duration (days): 28 | |
| Inclusion criteria | 1)male or female; 2)20–74 years; 3)positive for SARS-CoV-2 based on a nucleic acid amplification test of a respiratory tract sample taken at enrollment; 4)pulmonary lesions confirmed by chest imaging; 5)fever C 37.5 C; 6)written, informed consent obtained from the patient. |
| Exclusion criteria | 1) 11 or more days since onset of fever of ≥ 37.5 °C; 2) the infection episode was a relapse or reinfection; 3) SpO2<94% without oxygen therapy; 4) Patients who are pregnant or may be pregnant; 5) Patients with severe hepatic or renal impairment |
| Interventions | |
| Treatment
Favipiravir Initial dose: 1800 mg orally 2 times/day on Day 1 - Maintenance dose: 800mg orally 2 times/day from Day 2 for up to 13 days. |
|
| Control
Placebo | |
| Participants | |
| Randomized 156 participants (n1=107 / n2= 49) | |
| Characteristics of participants N=156 Mean age : 45.3 104 males Severity : Mild: n=154 / Moderate: n=2/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Efficacy, time to alleviation of body temperature, SpO2, and chest image findings, and time to SARS-CoV-2 RT-PCR negativity. | |
| In the report Composite outcome defined as the time to improvement in four clinical parameters (temperature, SpO2, findings on chest imaging, and viral clearance) | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| 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 prospective study registry and supplementary materials were used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The study (n=156) achieved the target sample size (n=144) specified in the trial registry. The primary outcome and safety outcomes indicated in the paper reflects those in the registry. Some secondary outcomes (e.g. mortality) are reported in the paper, but were not pre-specified in the trial registry. Of note: there was a large loss to follow up and cross-over of patients from the placebo group to the treatment group although patients were analyzed in the group they were randomized too." |