Abstract：
OBJECTIVE: This study aimed to evaluate the antiviral effects and safety of nafamostat in early-onset patients with coronavirus disease 2019 (COVID-19).
METHODS: In this exploratory multicentre randomized controlled trial, patients were assigned to three groups within 5 days of symptom onset, with 10 participants in each group: nafamostat at either 0.2 mg/kg/h or 0.1 mg/kg/h or a standard-of-care group. The primary endpoint was area under the curve for decrease in SARS-CoV-2 viral load in nasopharyngeal samples from baseline to day 6.
RESULTS: Of the 30 randomized patients, 19 received nafamostat. Overall, 10 patients received low-dose nafamostat, 9 patients received high-dose nafamostat, and 10 received standard-of-care. The detected viruses were Omicron strains. The regression coefficient for area under the curve for decrease in viral load as the response variable and nafamostat dose per body weight as the explanatory variable showed a significant relationship of -40.1 (95% confidence interval, -74.1 to -6.2; P = 0.022). Serious adverse events were not observed in either group. Phlebitis occurred in ca. 50% of patients treated with nafamostat.
CONCLUSIONS: Nafamostat exerts virus load-reducing effects in patients with early-onset COVID-19.
METHODS: In this exploratory multicentre randomized controlled trial, patients were assigned to three groups within 5 days of symptom onset, with 10 participants in each group: nafamostat at either 0.2 mg/kg/h or 0.1 mg/kg/h or a standard-of-care group. The primary endpoint was area under the curve for decrease in SARS-CoV-2 viral load in nasopharyngeal samples from baseline to day 6.
RESULTS: Of the 30 randomized patients, 19 received nafamostat. Overall, 10 patients received low-dose nafamostat, 9 patients received high-dose nafamostat, and 10 received standard-of-care. The detected viruses were Omicron strains. The regression coefficient for area under the curve for decrease in viral load as the response variable and nafamostat dose per body weight as the explanatory variable showed a significant relationship of -40.1 (95% confidence interval, -74.1 to -6.2; P = 0.022). Serious adverse events were not observed in either group. Phlebitis occurred in ca. 50% of patients treated with nafamostat.
CONCLUSIONS: Nafamostat exerts virus load-reducing effects in patients with early-onset COVID-19.
摘要：
目的：本研究旨在评估nafamostat在2019年冠状病毒病（COVID-19）早发性患者中的抗病毒作用和安全性。
方法：在这项探索性多中心随机对照试验中，患者在症状发作后5天内被分为三组，每组10名参与者：nafamostat剂量为0.2mg/kg/h或0.1mg/kg/h或标准护理组。主要终点是鼻咽样本中SARS-CoV-2病毒载量从基线至第6天下降的曲线下面积。
结果：在30名随机患者中，19人收到了nafamostat。总的来说,10名患者接受了低剂量nafamostat，9名患者接受了高剂量nafamostat，10人接受了标准护理。检测到的病毒是Omicron毒株。作为应答变量的病毒载量减少的曲线下面积和作为解释变量的nafamostat剂量/体重的回归系数显示出-40.1的显着关系（95％置信区间，-74.1至-6.2；P=0.022）。两组均未出现严重不良事件。静脉炎发生在约。50%的患者接受nafamostat治疗。
结论：Nafamostat对早发性COVID-19患者具有降低病毒载量的作用。
方法：在这项探索性多中心随机对照试验中，患者在症状发作后5天内被分为三组，每组10名参与者：nafamostat剂量为0.2mg/kg/h或0.1mg/kg/h或标准护理组。主要终点是鼻咽样本中SARS-CoV-2病毒载量从基线至第6天下降的曲线下面积。
结果：在30名随机患者中，19人收到了nafamostat。总的来说,10名患者接受了低剂量nafamostat，9名患者接受了高剂量nafamostat，10人接受了标准护理。检测到的病毒是Omicron毒株。作为应答变量的病毒载量减少的曲线下面积和作为解释变量的nafamostat剂量/体重的回归系数显示出-40.1的显着关系（95％置信区间，-74.1至-6.2；P=0.022）。两组均未出现严重不良事件。静脉炎发生在约。50%的患者接受nafamostat治疗。
结论：Nafamostat对早发性COVID-19患者具有降低病毒载量的作用。
