Abstract
BackgroundThis 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.MethodsWe 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.DiscussionOur study contributes to the establishment of therapeutic strategy in COVID-19 pneumonia by evaluating the therapeutic effect and safety of nafamostat mesilate.Trial registrationClinicalTrials.gov NCT04418128. Registered on 5 June 2020.
Highlights
Background and rationale {6a} The COVID-19 epidemic expanded to the whole world since it started from the Wuhan area in China in December 2019
Data Monitoring Committee (DMC) is strongly recommended in other clinical studies with significant safety concerns in which double-blind treatment is assigned, this trial is a phase 2 clinical study with confirmed drug safety and is an open label trial, not a double-blinded study
In May 2020, an amendment was submitted to the MFDS. Protocol changes in this amendment included the following: the contents of patients without standard treatment were revised by referring to the definition of vulnerable subjects in the clinical trial management criteria, addition of serious adverse events to the discontinuation criteria, NEWS (National Early Warning Score) added in clinical data collection, revision of the definition of adverse events and actions to be taken in the event of an adverse reaction, and addition of information regarding the storage institution and disposal method of the consent form for human materials
Summary
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
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