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

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 COVI...

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Autores principales:	Kyunglan Moon, Kyung-Wook Hong, In-Gyu Bae
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	COVID-19 Randomized controlled trial protocol Nafamostat mesilate Time to improvement Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/72069f30a36449dbb9ccdebb6b130649
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spelling	oai:doaj.org-article:72069f30a36449dbb9ccdebb6b1306492021-11-28T12:28:12ZTreatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial10.1186/s13063-021-05760-11745-6215https://doaj.org/article/72069f30a36449dbb9ccdebb6b1306492021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05760-1https://doaj.org/toc/1745-6215Abstract 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.Kyunglan MoonKyung-Wook HongIn-Gyu BaeBMCarticleCOVID-19Randomized controlled trialprotocolNafamostat mesilateTime to improvementMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 Randomized controlled trial protocol Nafamostat mesilate Time to improvement Medicine (General) R5-920
spellingShingle	COVID-19 Randomized controlled trial protocol Nafamostat mesilate Time to improvement Medicine (General) R5-920 Kyunglan Moon Kyung-Wook Hong In-Gyu Bae Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial
description	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.
format	article
author	Kyunglan Moon Kyung-Wook Hong In-Gyu Bae
author_facet	Kyunglan Moon Kyung-Wook Hong In-Gyu Bae
author_sort	Kyunglan Moon
title	Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial
title_short	Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial
title_full	Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial
title_fullStr	Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial
title_full_unstemmed	Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial
title_sort	treatment effect of nafamostat mesylate in patients with covid-19 pneumonia: study protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/72069f30a36449dbb9ccdebb6b130649
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Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial

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