TY - JOUR
T1 - Multicenter, single-blind, randomized controlled study of the efficacy and safety of favipiravir and nafamostat mesilate in patients with COVID-19 pneumonia
AU - Ikeda, Mahoko
AU - Okugawa, Shu
AU - Kashiwabara, Kosuke
AU - Moritoyo, Takashi
AU - Kanno, Yoshiaki
AU - Jubishi, Daisuke
AU - Hashimoto, Hideki
AU - Okamoto, Koh
AU - Tsushima, Kenji
AU - Uchida, Yasuki
AU - Mitsumura, Takahiro
AU - Igari, Hidetoshi
AU - Tsutsumi, Takeya
AU - Araoka, Hideki
AU - Yatera, Kazuhiro
AU - Yamamoto, Yoshihiro
AU - Nakamura, Yuki
AU - Otani, Amato
AU - Yamashita, Marie
AU - Wakimoto, Yuji
AU - Shinohara, Takayuki
AU - Adachi-Katayama, Maho
AU - Oyabu, Tatsunori
AU - Kanematsu, Aoi
AU - Harada, Sohei
AU - Takeshita, Yuichiro
AU - Nakano, Yasutaka
AU - Miyazaki, Yasunari
AU - Sakao, Seiichiro
AU - Saito, Makoto
AU - Ogura, Sho
AU - Yamasaki, Kei
AU - Kawasuji, Hitoshi
AU - Hataji, Osamu
AU - Inoue, Jun Ichiro
AU - Seto, Yasuyuki
AU - Moriya, Kyoji
N1 - Publisher Copyright:
© 2022
PY - 2023/3
Y1 - 2023/3
N2 - 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.
AB - 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.
KW - COVID-19
KW - Favipiravir
KW - Nafamostat mesilate
KW - Pneumonia
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85148059719&partnerID=8YFLogxK
U2 - 10.1016/j.ijid.2022.12.039
DO - 10.1016/j.ijid.2022.12.039
M3 - 学術論文
C2 - 36610659
AN - SCOPUS:85148059719
SN - 1201-9712
VL - 128
SP - 355
EP - 363
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
ER -