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A Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study To Evaluate the Efficacy and Safety of Camostat Mesylate (DWJ1248) in Adult Patients with Mild to Moderate COVID-19

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Author(s)
Yeon-Sook KimSeng-Ho JeonJunghee KimJong Hoon KohSeung Won RaJi Won KimYeonjae KimChoon Kwan KimYun Chul ShinBeo Deul KangSeung Ji KangChul Hee ParkBoyoung LeeJi Yeon LeeChung Hoon LeeJae-Phil ChoiJin Yong KimShi Nae YuKyong Ran PeckSung-Han KimJung Yeon HeoHyun Ah KimHyun-Jin ParkJongwon ChoiJumi HanJooHyun KimHyoung Jun KimSe Hee HanAeri YoonMiHee ParkSuJung ParkYuKyung KimMinji JungMyoung-Don Oh
Keimyung Author(s)
Kim, Hyun Ah
Department
Dept. of Internal Medicine (내과학)
Journal Title
Antimicrob Agents Chemother
Issued Date
2023
Volume
67
Issue
1
Keyword
SARS-CoV-2antiviral agentcamostat mesylateclinical trialcoronavirus disease 2019
Abstract
Although several antiviral agents have become available for coronavirus disease 2019 (COVID-19) treatment, oral drugs are still limited. Camostat mesylate, an orally bioavailable serine protease inhibitor, has been used to treat chronic pancreatitis in South Korea, and it has an in vitro inhibitory potential against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study was a double-blind, randomized, placebo-controlled, multicenter, phase 2 clinical trial in mild to moderate COVID-19 patients. We randomly assigned patients to receive either camostat mesylate (DWJ1248) or placebo orally for 14 days. The primary endpoint was time to clinical improvement of subject symptoms within 14 days, measured using a subjective 4-point Likert scale. Three hundred forty-two patients were randomized. The primary endpoint was nonsignificant, where the median times to clinical improvement were 7 and 8 days in the camostat mesylate group and the placebo group, respectively (hazard ratio [HR] = 1.09; 95% confidence interval [CI], 0.84 to 1.43; P = 0.50). A post hoc analysis showed that the difference was greatest at day 7, without reaching significance. In the high-risk group, the proportions of patients with clinical improvement up to 7 days were 45.8% (50/109) in the camostat group and 38.4% (40/104) in the placebo group (odds ratio [OR] = 1.33; 95% CI, 0.77 to 2.31; P = 0.31); the ordinal scale score at day 7 improved in 20.0% (18/90) of the camostat group and 13.3% (12/90) of the placebo group (OR = 1.68; 95% CI, 0.75 to 3.78; P = 0.21). Adverse events were similar in the two groups. Camostat mesylate was safe in the treatment of COVID-19. Although this study did not show clinical benefit in patients with mild to moderate COVID-19, further clinical studies for high-risk patients are needed. (This trial was registered with ClinicalTrials.gov under registration no. NCT04521296).
Keimyung Author(s)(Kor)
김현아
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1098-6596
Source
https://journals.asm.org/doi/10.1128/aac.00452-22
DOI
10.1128/aac.00452-22
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/44737
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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