학술논문
Multicenter, single-blind, randomized controlled study of the efficacy and safety of favipiravir and nafamostat mesilate in patients with COVID-19 pneumonia
Document Type
article
Author
Mahoko Ikeda; Shu Okugawa; Kosuke Kashiwabara; Takashi Moritoyo; Yoshiaki Kanno; Daisuke Jubishi; Hideki Hashimoto; Koh Okamoto; Kenji Tsushima; Yasuki Uchida; Takahiro Mitsumura; Hidetoshi Igari; Takeya Tsutsumi; Hideki Araoka; Kazuhiro Yatera; Yoshihiro Yamamoto; Yuki Nakamura; Amato Otani; Marie Yamashita; Yuji Wakimoto; Takayuki Shinohara; Maho Adachi-Katayama; Tatsunori Oyabu; Aoi Kanematsu; Sohei Harada; Yuichiro Takeshita; Yasutaka Nakano; Yasunari Miyazaki; Seiichiro Sakao; Makoto Saito; Sho Ogura; Kei Yamasaki; Hitoshi Kawasuji; Osamu Hataji; Jun-Ichiro Inoue; Yasuyuki Seto; Kyoji Moriya
Source
International Journal of Infectious Diseases, Vol 128, Iss , Pp 355-363 (2023)
Subject
Language
English
ISSN
1201-9712
Abstract
Objectives: To evaluate the efficacy and safety of nafamostat combined with favipiravir for the treatment of COVID-19. Methods: We conducted a multicenter, randomized, single-blind, placebo-controlled, parallel assignment study in hospitalized patients with mild-to-moderate COVID-19 pneumonia. Patients were randomly assigned to receive favipiravir alone (n = 24) or nafamostat with favipiravir (n = 21). The outcomes included changes in the World Health Organization clinical progression scale score, time to improvement in body temperature, and improvement in oxygen saturation (SpO2). Results: There was no significant difference in the changes in the clinical progression scale between nafamostat with favipiravir and favipiravir alone groups (median, -0.444 vs -0.150, respectively; least-squares mean difference, -0.294; P = 0.364). The time to improvement in body temperature was significantly shorter in the combination group (5.0 days; 95% confidence interval, 4.0-7.0) than in the favipiravir group (9.0 days; 95% confidence interval, 7.0-18.0; P =0.009). The changes in SpO2 were greater in the combination group than in the favipiravir group (0.526% vs -1.304%, respectively; least-squares mean difference, 1.831; P = 0.022). No serious adverse events or deaths were reported, but phlebitis occurred in 57.1% of the patients in the combination group. Conclusion: Although our study showed no differences in clinical progression, earlier defervescence, and recovery of SpO2 were observed in the combination group.