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.

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).

• Authors: Yeon-Sook Kim, Seng-Ho Jeon, Junghee Kim, Jong Hoon Koh, Seung Won Ra, Ji Won Kim, Yeonjae Kim, Choon Kwan Kim, Yun Chul Shin, Beo Deul Kang, Seung Ji Kang, Chul Hee Park, Boyoung Lee, Ji Yeon Lee, Chung Hoon Lee, Jae-Phil Choi, Jin Yong Kim, Shi Nae Yu, Kyong Ran Peck, Sung-Han Kim, Jung Yeon Heo, Hyun Ah Kim, Hyun-Jin Park, Jongwon Choi, Jumi Han, JooHyun Kim, Hyoung Jun Kim, Se Hee Han, Aeri Yoon, MiHee Park, SuJung Park, YuKyung Kim, Minji Jung, Myoung-Don Oh
• Journal: Antimicrobial agents and chemotherapy (Antimicrob Agents Chemother) Vol. 67 Issue 1 Pg. e0045222 (01 24 2023) ISSN: 1098-6596 [Electronic] United States
• PMID: 36515544 (Publication Type: Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• camostat
• Guanidines
• Esters

Topics

• Humans
• Adult
• COVID-19
• SARS-CoV-2
• Guanidines
• Esters
• Double-Blind Method
• Treatment Outcome