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Recent:   

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

Kim et al., Antimicrobial Agents and Chemotherapy, doi:10.1128/aac.00452-22, NCT04521296
Jan 2023  
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Time to clinical improvem.. 8% primary Improvement Relative Risk Improvement, high-risk su.. 25% Improvement, high-risk.. 46% Ordinal scale improvement.. 40% Ordinal scale improve.. (b) 58% Camostat  Kim et al.  EARLY TREATMENT  DB RCT Is early treatment with camostat beneficial for COVID-19? Double-blind RCT 323 patients in South Korea (Feb - May 2021) No significant difference in recovery c19early.org Kim et al., Antimicrobial Agents and C.., Jan 2023 Favorscamostat Favorscontrol 0 0.5 1 1.5 2+
Double-blind RCT with 342 mild to moderate COVID-19 outpatients in South Korea, showing no significant difference in time to clinical improvement with camostat mesylate. In a post-hoc subgroup analysis of high-risk patients, there were non-statistically significant trends towards faster improvement in ordinal scale scores and subjective symptom scores at day 7 with treatment. Viral cultures suggested faster viral clearance with treatment, without statistical significance.
time to clinical improvement, 8.3% lower, HR 0.92, p = 0.54, treatment 161, control 162, inverted to make HR<1 favor treatment, primary outcome.
improvement, 24.8% lower, HR 0.75, p = 0.31, treatment 109, control 104, inverted to make HR<1 favor treatment, high-risk subgroup, day 7.
improvement, 46.2% lower, HR 0.54, p = 0.06, treatment 77, control 78, inverted to make HR<1 favor treatment, high-risk subgroup, mFAS, day 7.
ordinal scale improvement, 40.5% lower, HR 0.60, p = 0.21, treatment 109, control 104, inverted to make HR<1 favor treatment, high-risk subgroup, day 7.
ordinal scale improvement, 58.2% lower, HR 0.42, p = 0.06, treatment 77, control 78, inverted to make HR<1 favor treatment, high-risk subgroup, mFAS, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kim et al., 24 Jan 2023, Double Blind Randomized Controlled Trial, placebo-controlled, South Korea, peer-reviewed, median age 53.0, mean age 51.4, 34 authors, study period February 2021 - May 2021, trial NCT04521296 (history). Contact: mdohmd@snu.ac.kr, jhkim302@daewoong.co.kr.
This PaperMiscellaneousAll
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
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
Antimicrobial Agents and Chemotherapy, doi:10.1128/aac.00452-22
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 doubleblind, 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,
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