甲磺酸萘莫司他治疗 COVID-19 肺炎患者的效果：一项随机对照试验的研究方案。

Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial.

机构信息

Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, Republic of Korea.

出版信息

Trials. 2021 Nov 23;22(1):832. doi: 10.1186/s13063-021-05760-1.

DOI:10.1186/s13063-021-05760-1

PMID:34814935

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8609248/

Abstract

BACKGROUND

This study is designed to evaluate the main hypothesis that nafamostat mesilate with standard therapy improves the severity and mortality rate in patients with COVID-19 pneumonia.

METHODS

We conduct a randomized, open type, multi-institute/center, 2-group clinical trial with COVID-19 pneumonia patients in Korea. Eighty four patients with COVID-19 pneumonia are randomly assigned to intervention group or control group. Patients in intervention group receive the standard therapy with a dose of 0.1 to 0.2 mg/kg/h (2.4 to 4.8 mg/kg/day) of nafamostat mesilate. Patients in control group receive the standard therapy such as lopinavir/ritonavir, hydroxychloroquine, oxygen therapy, non-invasive and invasive ventilator, antibiotic therapy, renal-replacement therapy, and extracorporeal membrane oxygenation (ECMO). The primary outcome is proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status, as well as secondary outcome comprised change in National Early Warning Score, duration of hospitalization, incidence of new-non-invasive ventilation or high flow oxygen use or ventilator, mortality at day 28, viral load change, and adverse events.

DISCUSSION

Our study contributes to the establishment of therapeutic strategy in COVID-19 pneumonia by evaluating the therapeutic effect and safety of nafamostat mesilate.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04418128. Registered on 5 June 2020.

摘要

背景

本研究旨在评估主要假设，即甲磺酸萘莫司他联合标准疗法可改善 COVID-19 肺炎患者的严重程度和死亡率。

方法

我们在韩国进行了一项随机、开放型、多机构/中心、2 组临床试验，纳入 COVID-19 肺炎患者。84 例 COVID-19 肺炎患者被随机分配至干预组或对照组。干预组患者接受标准治疗，剂量为 0.1 至 0.2mg/kg/h（2.4 至 4.8mg/kg/天）的甲磺酸萘莫司他。对照组患者接受标准治疗，如洛匹那韦/利托那韦、羟氯喹、氧疗、无创和有创呼吸机、抗生素治疗、肾脏替代治疗和体外膜氧合（ECMO）。主要结局是临床改善的患者比例，定义为从医院出院或临床状态的 7 级分类量表下降 2 级，次要结局包括国家早期预警评分的变化、住院时间、新非侵入性通气或高流量氧气使用或呼吸机的发生率、第 28 天死亡率、病毒载量变化和不良事件。