Efficacy and Safety of Favipiravir in Moderate COVID-19 Pneumonia Patients without Oxygen Therapy: A Randomized, Phase III Clinical Trial
Shinkai et al.,
Efficacy and Safety of Favipiravir in Moderate COVID-19 Pneumonia Patients without Oxygen Therapy: A..,
Infectious Diseases and Therapy, doi:10.1007/s40121-021-00517-4
RCT 156 patients in Japan, 107 treated with favipiravir, showing significant improvement in a composite outcome defined as the time to improvement in temperature, SpO2, CT findings, and recovery to PCR-.
time to improvement, 37.1% lower, HR 0.63, p = 0.01, treatment 107, control 49, adjusted per study, inverted to make HR<1 favor treatment, Cox proportional hazards, composite time to improvement in temperature, SpO2, CT findings, and recovery to PCR-.
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time to improvement, 58.5% lower, HR 0.41, p = 0.01, treatment 47, control 13, adjusted per study, inverted to make HR<1 favor treatment, <5 days from onset of fever, Cox proportional hazards, composite time to improvement in temperature, SpO2, CT findings, and recovery to PCR-.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Shinkai et al., 27 Aug 2021, Single Blind Randomized Controlled Trial, Japan, peer-reviewed, 39 authors, average treatment delay 4.8 days.
Abstract: Infect Dis Ther (2021) 10:2489–2509
https://doi.org/10.1007/s40121-021-00517-4
ORIGINAL RESEARCH
Efficacy and Safety of Favipiravir in Moderate COVID19 Pneumonia Patients without Oxygen Therapy:
A Randomized, Phase III Clinical Trial
Masaharu Shinkai . Kenji Tsushima . Shingo Tanaka . Eri Hagiwara . Norihito Tarumoto . Ichiro Kawada .
Yuji Hirai . Sho Fujiwara . Yuko Komase . Takeshi Saraya . Hidefumi Koh . Naho Kagiyama . Megumi Shimada .
Daiki Kanou . Shinichi Antoku . Yujiro Uchida . Yutaka Tokue . Mikio Takamori . Yasuhiro Gon . Kenya Ie .
Yoshitaka Yamazaki . Kazumasa Harada . Naoki Miyao . Takashi Naka . Mitsunaga Iwata . Atsushi Nakagawa .
Kazutoshi Hiyama . Yoshihiko Ogawa . Masahiro Shinoda . Shinichiro Ota . Takatomo Hirouchi . Jiro Terada .
Shuichi Kawano . Takashi Ogura . Tsutomu Sakurai . Yoshihiko Matsumoto . Hiroyuki Kunishima .
Osamu Kobayashi . Satoshi Iwata
Received: May 21, 2021 / Accepted: July 27, 2021 / Published online: August 27, 2021
Ó The Author(s) 2021
ABSTRACT
Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of
coronavirus disease 2019 (COVID-19), is an
enveloped, single-stranded RNA virus. Favipi-
Supplementary Information The online version
contains supplementary material available at https://
doi.org/10.1007/s40121-021-00517-4.
ravir is an orally administrable antiviral drug
whose mechanism of action is to selectively
inhibit RNA-dependent RNA polymerase. A
preliminary trial in COVID-19 patients reported
significant improvements across a multitude of
clinical parameters, but these findings have not
been confirmed in an adequate well-controlled
trial. We conducted a randomized, single-blind,
placebo-controlled Phase III trial assessing the
efficacy and safety of favipiravir in patients with
M. Shinkai M. Shinoda S. Ota T. Hirouchi
Department of Respiratory Medicine, Tokyo
Shinagawa Hospital, 6-3-22 Higashioi, Shinagawaku, Tokyo 140-8522, Japan
N. Tarumoto
Department of Infectious Disease and Infection
control, Saitama Medical University Hospital, 38
Morohongo, Moroyama-machi, Iruma-gun, Saitama
350-0495, Japan
K. Tsushima J. Terada
Department of Pulmonary Medicine, School of
Medicine, International University of Health and
Welfare, 852 Hatakeda, Narita, Chiba 286-8520,
Japan
I. Kawada
Division of Pulmonary Medicine, Department of
Medicine, School of Medicine, Keio University, 35
Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
S. Tanaka
Department of Otolaryngology, Self-Defense Forces
Central Hospital, 1-2-24 Ikejiri, Setagaya-ku, Tokyo
154-8532, Japan
E. Hagiwara T. Ogura
Department of Respiratory Medicine, Kanagawa
Cardiovascular and Respiratory Center, 6-16-1
Tomiokahigashi, Kanazawa-ku, Yokohama,
Kanagawa 236-0051, Japan
Y. Hirai
Department of Infectious Diseases, Tokyo Medical
University Hachioji Medical Center, 1163
Tatemachi, Hachioji, Tokyo 193-0998, Japan
S. Fujiwara
Department of Infectious Diseases, Tokyo
Metropolitan Cancer and Infectious Diseases Center
Komagome Hospital, 3-18-22 Honkomagome,
Bunkyo-ku, Tokyo 113-8677, Japan
2490
moderate pneumonia not requiring oxygen
therapy.
Methods: COVID-19 patients with moderate
pneumonia (SpO2 C 94%) within 10 days of
onset of fever (temperature C 37.5 °C) were
assigned to receive either placebo or favipiravir
(1800 mg twice a day on Day 1, followed by
800 mg twice a day for up to 13 days) in a ratio
of 1:2. An adaptive design was used to re-estimate the sample size. The primary endpoint was
a..
Late treatment
is less effective
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