Summary of COVID-19 camostat studies

1. Karolyi et al., Camostat Mesylate Versus Lopinavir/Ritonavir in Hospitalized Patients With COVID-19—Results From a Randomized, Controlled, Open Label, Platform Trial (ACOVACT)

201 patient camostat late treatment RCT: 72% lower mortality (p=0.1), 70% lower ventilation (p=0.02), 60% lower combined mortality/intubation (p=0.04), and 18% faster recovery (p=0.005).
RCT 201 hospitalized COVID-19 patients showing faster clinical improvement, less progression to mechanical ventilation or death, and shorter hospital stay with camostat mesylate compared to lopinavir/ritonavir. There was also a trend towards lower 29-day mortality with camostat. Authors note that the lopinavir/ritonavir dose likely did not reach effective levels, so it may be considered similar to a placebo group.
Jul 2022, Frontiers in Pharmacology, https://www.frontiersin.org/articles/10.3389/fphar.2022.870493/full, https://c19p.org/karolyi

2. Terada et al., Favipiravir, camostat, and ciclesonide combination therapy in patients with moderate COVID-19 pneumonia with/without oxygen therapy: An open-label, single-center phase 3 randomized clinical trial

117 patient camostat late treatment RCT: 8% lower progression (p=1) and 40% higher hospital discharge (p=0.04).
RCT 117 hospitalized patients with moderate COVID-19 pneumonia in Japan, showing a shorter time to discharge with favipiravir, camostat, and ciclesonide combination therapy compared to favipiravir monotherapy. Subgroup analysis showed greater benefit in patients ≤60 years old and those with less severe disease not requiring oxygen. There were no significant differences between groups in clinical findings, laboratory values, or adverse events. The mortality numbers in the main results table and the text are different, without explanation.
Jun 2022, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S2589537022002140, https://c19p.org/terada

3. Kinoshita et al., A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study)

155 patient camostat early treatment RCT: 67% lower progression (p=1), 50% lower need for oxygen therapy (p=0.37), 1% worse recovery (p=1), and 1% worse viral clearance (p=0.97).
RCT 155 hospitalized patients showing no significant differences with camostat.
Sep 2022, BMC Medicine, https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02518-7, https://c19p.org/kinoshita

4. Sakr et al., Camostat mesylate therapy in critically ill patients with COVID-19 pneumonia

122 patient camostat late treatment PSM study: 69% lower mortality (p=0.001), 10% lower ventilation (p=1), and 17% longer hospitalization (p=0.35).
Retrospective 371 critically ill COVID-19 patients showing lower mortality with camostat mesylate treatment.
Apr 2021, Intensive Care Medicine, https://link.springer.com/10.1007/s00134-021-06395-1, https://c19p.org/sakr

5. Gunst et al., Efficacy of the TMPRSS2 inhibitor camostat mesilate in patients hospitalized with Covid-19-a double-blind randomized controlled trial

205 patient camostat late treatment RCT: 18% lower mortality (p=0.75), 31% lower ventilation (p=0.65), 20% lower ICU admission (p=0.61), and 15% improved recovery (p=0.28).
RCT 205 hospitalized patients showing no significant benefit with camostat. There was a trend towards lower risk of ICU admission or death in the camostat group (10% vs. 18% for placebo), but the study was not powered for this endpoint. Viral load and inflammatory markers were not significantly different between groups. The study was underpowered due to faster than expected clinical improvement.
May 2021, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S2589537021001292, https://c19p.org/gunst

6. Tare et al., The DAWN antivirals trial: process evaluation of a COVID-19 trial in general practice

36 patient camostat early treatment RCT: 33% improved recovery (p=0.7).
Small early terminated RCT showing better recovery with camostat treatment, without statistical significance.
Nov 2023, BJGP Open, http://bjgpopen.org/lookup/doi/10.3399/BJGPO.2023.0109, https://c19p.org/tarecm

7. Chupp et al., A Phase 2 Randomized, Double-Blind, Placebo-controlled Trial of Oral Camostat Mesylate for Early Treatment of COVID-19 Outpatients Showed Shorter Illness Course and Attenuation of Loss of Smell and Taste

70 patient camostat early treatment RCT: 37% improved recovery (p=0.15).
RCT 70 outpatients showing significantly lower symptom scores at day 6, faster recovery, and improved taste/smell, and fatigue with camostat treatment. There was no significant difference for viral load. The recovery result is from [bmcinfectdis.biomedcentral.com].
Jan 2022, medRxiv, https://www.medrxiv.org/content/10.1101/2022.01.28.22270035, https://c19p.org/chupp

8. Hofmann-Winkler et al., Camostat Mesylate May Reduce Severity of Coronavirus Disease 2019 Sepsis: A First Observation

11 patient camostat ICU study: 58% lower mortality (p=0.55), 61% shorter ICU admission, and 56% improved recovery.
Retrospective 11 critically ill COVID-19 ICU patients with organ failure treated with camostat mesylate (6 patients) or HCQ (5 patients). Over an 8 day period, the severity of COVID-19 decreased in the camostat group as measured by a decline in the SOFA score, inflammatory markers, and improvement in oxygenation. A similar effect was not seen in the HCQ group.
Nov 2020, Critical Care Explorations, https://journals.lww.com/10.1097/CCE.0000000000000284, https://c19p.org/hofmannwinkler

9. Dhaliwal et al., A Randomised Phase II Trial in Early COVID-19, Assessing Use of Camostat by Blocking SARS-CoV-2 Spike Protein-initiated Membrane Fusion

34 patient camostat early treatment RCT: 14% lower hospitalization (p=1).
Early terminated RCT with 34 patients showing no significant differences with camostat treatment.
Mar 2022, NCT04455815, https://clinicaltrials.gov/study/NCT04455815, https://c19p.org/dhaliwal

10. Kim et al., 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

323 patient camostat early treatment RCT: 8% faster recovery (p=0.54).
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.
Jan 2023, Antimicrobial Agents and Chemotherapy, https://journals.asm.org/doi/10.1128/aac.00452-22, https://c19p.org/kim19

11. Parsonnet et al., A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Camostat Mesilate Compared to Standard of Care in Subjects With Mild-Moderate COVID-19

49 patient camostat early treatment RCT: 35% improved recovery (p=0.24), 86% improvement (p=0.11), and 41% improved viral clearance (p=0.24).
RCT 49 outpatients in the USA, showing no significant differences with camostat treatment.
May 2021, NCT04524663, https://clinicaltrials.gov/study/NCT04524663, https://c19p.org/parsonnet

12. Huh et al., Association of prescribed medications with the risk of COVID-19 infection and severity among adults in South Korea

44,046 patient camostat prophylaxis study: 14% more cases (p=0.84).
Retrospective database analysis showing no significant differences with camostat use.
Dec 2020, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971220325650, https://c19p.org/huh2cm

13. Tobback et al., Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial

96 patient camostat early treatment RCT: 36% higher hospitalization (p=1) and 8% improved recovery (p=0.84).
RCT 90 outpatients showing no significant difference in viral load or time to clinical improvement with camostat mesylate. The trial was discontinued early and did not reach the intended sample size. Authors note that combining camostat with a cathepsin inhibitor may improve efficacy.
Sep 2022, Int. J. Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1201971222003885, https://c19p.org/tobback

14. Sagent Pharmaceuticals et al., A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients

295 patient camostat early treatment RCT: 152% higher mortality (p=1), 13% lower progression (p=0.79), and 16% improved viral clearance (p=0.36).
RCT 295 outpatients in the USA, showing no significant differences with camostat.
Mar 2021, Sagent Pharmaceuticals, NCT04583592, https://clinicaltrials.gov/study/NCT04583592, https://c19p.org/sagent

15. Jilg et al., One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Phase 2 Trial

216 patient camostat late treatment RCT: 198% higher mortality (p=1), 18% higher hospitalization (p=1), and no change in recovery (p=0.99).
RCT 216 patients, 55% >5 days from symptom onset, showing no significant difference with camostat treatment.
Jun 2023, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciad342/7190261, https://c19p.org/jilg

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