Multicenter, single-blind, randomized controlled study of the efficacy and safety of favipiravir and nafamostat mesilate in patients with COVID-19 pneumonia. (March 2023)

• Record Type: Journal Article
• Authors: Ikeda, Mahoko; Okugawa, Shu; Kashiwabara, Kosuke; Moritoyo, Takashi; Kanno, Yoshiaki; Jubishi, Daisuke; Hashimoto, Hideki; Okamoto, Koh; Tsushima, Kenji; Uchida, Yasuki; Mitsumura, Takahiro; Igari, Hidetoshi; Tsutsumi, Takeya; Araoka, Hideki; Yatera, Kazuhiro; Yamamoto, Yoshihiro; Nakamura, Yuki; Otani, Amato; Yamashita, Marie; Wakimoto, Yuji; Shinohara, Takayuki; Adachi-Katayama, Maho; Oyabu, Tatsunori; Kanematsu, Aoi; Harada, Sohei; Takeshita, Yuichiro; Nakano, Yasutaka; Miyazaki, Yasunari; Sakao, Seiichiro; Saito, Makoto; Ogura, Sho; Yamasaki, Kei; Kawasuji, Hitoshi; Hataji, Osamu; Inoue, Jun-Ichiro; Seto, Yasuyuki; Moriya, Kyoji;
• Is Part Of: International journal of infectious diseases. Volume 128(2023)
• Page Start: 355
• Page End: 363
• Publication Date: 2023-03
• Subjects: COVID-19 -- SARS-CoV-2 -- Pneumonia -- Nafamostat mesilate -- Favipiravir; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2022.12.039
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: The efficacy of favipiravir with or without nafamostat against COVID-19 was studied. The changes in the clinical progression scale did not differ between the groups. The time to improvement in body temperature was shorter in the combination group. An early recovery of oxygen saturation was also observed in the combination group. 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.