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0 0.5 1 1.5 2+ Oxygen therapy -16% Improvement Relative Risk Oxygen therapy, ≤48 hours 19% Viral clearance, day 15 -16% Viral clearance, day 10 6% Viral clearance, day 7 1% Viral clearance, day 4 6% Favipiravir  Iwata et al.  EARLY TREATMENT  DB RCT Is early treatment with favipiravir beneficial for COVID-19? Double-blind RCT 86 patients in Japan Trial underpowered for serious outcomes Iwata et al., J. Infection and Chemoth.., Oct 2023 Favors favipiravir Favors control

Findings from a discontinued clinical trial of favipiravir in high-risk patients with early-onset COVID-19

Iwata et al., Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2023.10.010, jRCT2041210004
Oct 2023  
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Early terminated RCT 84 patients in Japan, showing no significant difference in outcomes with favipiravir treatment. There was a trend for improved efficacy for patients enrolled within 48 hours of symptom onset.
risk of oxygen therapy, 16.2% higher, RR 1.16, p = 0.73, treatment 12 of 43 (27.9%), control 12 of 43 (27.9%), adjusted per study, odds ratio converted to relative risk, multivariable, day 28.
risk of oxygen therapy, 18.5% lower, RR 0.81, p = 0.77, treatment 5 of 24 (20.8%), control 6 of 22 (27.3%), NNT 16, adjusted per study, odds ratio converted to relative risk, patients with onset ≤48 hours, multivariable, day 28.
risk of no viral clearance, 15.9% higher, RR 1.16, p = 0.66, treatment 21 of 41 (51.2%), control 19 of 43 (44.2%), day 15.
risk of no viral clearance, 6.0% lower, RR 0.94, p = 0.82, treatment 26 of 41 (63.4%), control 29 of 43 (67.4%), NNT 25, day 10.
risk of no viral clearance, 0.9% lower, RR 0.99, p = 1.00, treatment 34 of 41 (82.9%), control 36 of 43 (83.7%), NNT 126, day 7.
risk of no viral clearance, 5.6% lower, RR 0.94, p = 0.48, treatment 36 of 41 (87.8%), control 40 of 43 (93.0%), NNT 19, day 4.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Iwata et al., 12 Oct 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Japan, peer-reviewed, 13 authors, trial jRCT2041210004.
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Findings from a discontinued clinical trial of favipiravir in high-risk patients with early-onset COVID-19
Satoshi Iwata, Osamu Kobayashi, Kazuyoshi Kurashima, Yohei Doi, Hiroyuki Kunishima, Masaharu Shinkai, Kenji Tsushima, Masaya Yamato, Akira Kano, Makoto Hibino, Takahiro Yamatake, Tsutomu Sakurai, Takashi Ogura
Journal of Infection and Chemotherapy, doi:10.1016/j.jiac.2023.10.010
Introduction: Favipiravir terminates severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication. Accordingly, early administration of favipiravir to SARS-CoV-2-infected coronavirus disease 2019 (COVID-19) patients may be expected to suppress disease progression. Methods: A randomized double-blind placebo-controlled trial was conducted to demonstrate efficacy of favipiravir in reducing disease progression in patients with mild COVID-19. The participants were unvaccinated patients with comorbidities and at risk of progression to severe disease. Patients were enrolled within 72 hours of disease onset and randomized to receive either favipiravir (1800 mg/dose on Day 1 followed by 800 mg/dose) or matching placebo twice daily for 10 days. The primary endpoint was the proportion of patients requiring oxygen therapy within 28 days of randomization. Results: The trial was discontinued after enrolling 84 patients due to slower than anticipated enrollment caused by rapid uptake of SARS-CoV-2-vaccines and the emergence of the Omicron variant. Results from the 84 patients demonstrated no significant difference in all clinical outcomes. In post-hoc analyses, favipiravir treatment showed higher efficacy in patients within 48 hours of onset. No deaths or severe adverse events were documented in the favipiravir group. Plasma concentrations of favipiravir from Day 2 onward were maintained above 40 μg/mL. Conclusions: Conducting clinical trials for pathogens like SARS-CoV-2 that rapidly accumulate mutations leading to altered disease characteristics carries significant risks unless it can be done in a short period. Therefore, it would be important to prepare the comprehensive clinical trial platform that can appropriately and promptly evaluate drugs even under a pandemic.
Declaration of competing interest TY and TS are employees of the sponsor. SI reports consulting fees from Fujifilm Toyama Chemical, and Meiji Seika Pharma; lecture fees from Pfizer, and Gilead Sciences. YD reports consulting fees from Fujifilm Toyama Chemical, Shionogi, GSK, Gilead Sciences, and Moderna. MS reports consulting fees from Genova Inc., Shionogi, Ono Pharmaceutical, AstraZeneca, Pfizer, Chugai, and Fujitsu; lecture fees from Fujifilm Toyama Chemical. OK, HK, and KT report consulting fee from Fujifilm Toyama Chemical. KK, MY, AK, and TO report lecture fee from Fujifilm Toyama Chemical. J o u r n a l P r e -p r o o f
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