tetano
Editor, Senior Moderator
Int J Infect Dis
. 2023 Jan 3;S1201-9712(22)00684-1.
doi: 10.1016/j.ijid.2022.12.039. Online ahead of print.
Multicenter, Single-Blind, Randomized Controlled Study of the Efficacy and Safety of Favipiravir and Nafamostat Mesilate in Patients with COVID-19 Pneumonia
Mahoko Ikeda[SUP] 1 [/SUP], Shu Okugawa[SUP] 2 [/SUP], Kosuke Kashiwabara[SUP] 3 [/SUP], Takashi Moritoyo[SUP] 3 [/SUP], Yoshiaki Kanno[SUP] 2 [/SUP], Daisuke Jubishi[SUP] 2 [/SUP], Hideki Hashimoto[SUP] 2 [/SUP], Koh Okamoto[SUP] 2 [/SUP], Kenji Tsushima[SUP] 4 [/SUP], Yasuki Uchida[SUP] 5 [/SUP], Takahiro Mitsumura[SUP] 6 [/SUP], Hidetoshi Igari[SUP] 7 [/SUP], Takeya Tsutsumi[SUP] 8 [/SUP], Hideki Araoka[SUP] 9 [/SUP], Kazuhiro Yatera[SUP] 10 [/SUP], Yoshihiro Yamamoto[SUP] 11 [/SUP], Yuki Nakamura[SUP] 12 [/SUP], Amato Otani[SUP] 13 [/SUP], Marie Yamashita[SUP] 2 [/SUP], Yuji Wakimoto[SUP] 2 [/SUP], Takayuki Shinohara[SUP] 2 [/SUP], Maho Adachi-Katayama[SUP] 2 [/SUP], Tatsunori Oyabu[SUP] 2 [/SUP], Aoi Kanematsu[SUP] 2 [/SUP], Sohei Harada[SUP] 14 [/SUP], Yuichiro Takeshita[SUP] 4 [/SUP], Yasutaka Nakano[SUP] 5 [/SUP], Yasunari Miyazaki[SUP] 6 [/SUP], Seiichiro Sakao[SUP] 7 [/SUP], Makoto Saito[SUP] 15 [/SUP], Sho Ogura[SUP] 9 [/SUP], Kei Yamasaki[SUP] 10 [/SUP], Hitoshi Kawasuji[SUP] 11 [/SUP], Osamu Hataji[SUP] 12 [/SUP], Jun-Ichiro Inoue[SUP] 13 [/SUP], Yasuyuki Seto[SUP] 16 [/SUP], Kyoji Moriya[SUP] 17 [/SUP]
Affiliations
Abstract
Objectives: To evaluate the efficacy and safety of nafamostat combined with favipiravir for coronavirus disease 2019.
Methods: We conducted a multicenter, randomized, single-blind, placebo-controlled parallel assignment study in hospitalized patients with mild-to-moderate coronavirus disease 2019 pneumonia. Patients were randomly assigned to receive favipiravir alone (n=24) or nafamostat with favipiravir (n=21). Outcomes included changes in the WHO Clinical Progression Scale score, time to improvement in body temperature, and improvement in oxygen saturation (SpO[SUB]2[/SUB]).
Results: There was no significant difference in 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). Time to improvement in body temperature was significantly shorter in the combination group (5·0 days; 95% CI, 4·0-7·0) than in the favipiravir group (9·0 days; 95% CI, 7·0-18·0; p=0·009). Changes in SpO[SUB]2[/SUB] were greater in the combination group than that 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 patients in the combination group.
Conclusions: Although our study showed no differences in clinical progression, earlier defervescence and recovery of SpO[SUB]2[/SUB] were observed in the combination group.
The clinical trial registration number: This study was registered in the Japan Registry of Clinical Trials (identifier: jRCTs031200026) and WHO's International Clinical Trial Registry Platform (identifier: JPRN-jRCTs031200026).
Keywords: Coronavirus disease 2019; Favipiravir; Nafamostat mesilate; pneumonia; the severe acute respiratory syndrome coronavirus 2.
. 2023 Jan 3;S1201-9712(22)00684-1.
doi: 10.1016/j.ijid.2022.12.039. Online ahead of print.
Multicenter, Single-Blind, Randomized Controlled Study of the Efficacy and Safety of Favipiravir and Nafamostat Mesilate in Patients with COVID-19 Pneumonia
Mahoko Ikeda[SUP] 1 [/SUP], Shu Okugawa[SUP] 2 [/SUP], Kosuke Kashiwabara[SUP] 3 [/SUP], Takashi Moritoyo[SUP] 3 [/SUP], Yoshiaki Kanno[SUP] 2 [/SUP], Daisuke Jubishi[SUP] 2 [/SUP], Hideki Hashimoto[SUP] 2 [/SUP], Koh Okamoto[SUP] 2 [/SUP], Kenji Tsushima[SUP] 4 [/SUP], Yasuki Uchida[SUP] 5 [/SUP], Takahiro Mitsumura[SUP] 6 [/SUP], Hidetoshi Igari[SUP] 7 [/SUP], Takeya Tsutsumi[SUP] 8 [/SUP], Hideki Araoka[SUP] 9 [/SUP], Kazuhiro Yatera[SUP] 10 [/SUP], Yoshihiro Yamamoto[SUP] 11 [/SUP], Yuki Nakamura[SUP] 12 [/SUP], Amato Otani[SUP] 13 [/SUP], Marie Yamashita[SUP] 2 [/SUP], Yuji Wakimoto[SUP] 2 [/SUP], Takayuki Shinohara[SUP] 2 [/SUP], Maho Adachi-Katayama[SUP] 2 [/SUP], Tatsunori Oyabu[SUP] 2 [/SUP], Aoi Kanematsu[SUP] 2 [/SUP], Sohei Harada[SUP] 14 [/SUP], Yuichiro Takeshita[SUP] 4 [/SUP], Yasutaka Nakano[SUP] 5 [/SUP], Yasunari Miyazaki[SUP] 6 [/SUP], Seiichiro Sakao[SUP] 7 [/SUP], Makoto Saito[SUP] 15 [/SUP], Sho Ogura[SUP] 9 [/SUP], Kei Yamasaki[SUP] 10 [/SUP], Hitoshi Kawasuji[SUP] 11 [/SUP], Osamu Hataji[SUP] 12 [/SUP], Jun-Ichiro Inoue[SUP] 13 [/SUP], Yasuyuki Seto[SUP] 16 [/SUP], Kyoji Moriya[SUP] 17 [/SUP]
Affiliations
- PMID: 36610659
- PMCID: PMC9810545
- DOI: 10.1016/j.ijid.2022.12.039
Abstract
Objectives: To evaluate the efficacy and safety of nafamostat combined with favipiravir for coronavirus disease 2019.
Methods: We conducted a multicenter, randomized, single-blind, placebo-controlled parallel assignment study in hospitalized patients with mild-to-moderate coronavirus disease 2019 pneumonia. Patients were randomly assigned to receive favipiravir alone (n=24) or nafamostat with favipiravir (n=21). Outcomes included changes in the WHO Clinical Progression Scale score, time to improvement in body temperature, and improvement in oxygen saturation (SpO[SUB]2[/SUB]).
Results: There was no significant difference in 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). Time to improvement in body temperature was significantly shorter in the combination group (5·0 days; 95% CI, 4·0-7·0) than in the favipiravir group (9·0 days; 95% CI, 7·0-18·0; p=0·009). Changes in SpO[SUB]2[/SUB] were greater in the combination group than that 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 patients in the combination group.
Conclusions: Although our study showed no differences in clinical progression, earlier defervescence and recovery of SpO[SUB]2[/SUB] were observed in the combination group.
The clinical trial registration number: This study was registered in the Japan Registry of Clinical Trials (identifier: jRCTs031200026) and WHO's International Clinical Trial Registry Platform (identifier: JPRN-jRCTs031200026).
Keywords: Coronavirus disease 2019; Favipiravir; Nafamostat mesilate; pneumonia; the severe acute respiratory syndrome coronavirus 2.