AUTHOR=Karolyi M. , Pawelka E. , Omid S. , Koenig F. , Kauer V. , Rumpf B. , Hoepler W. , Kuran A. , Laferl H. , Seitz T. , Traugott M. , Rathkolb V. , Mueller M. , Abrahamowicz A. , Schoergenhofer C. , Hecking M. , Assinger A. , Wenisch C. , Zeitlinger M. , Jilma B. , Zoufaly A. 

TITLE=Camostat Mesylate Versus Lopinavir/Ritonavir in Hospitalized Patients With COVID-19—Results From a Randomized, Controlled, Open Label, Platform Trial (ACOVACT)

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 13 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.870493

DOI=10.3389/fphar.2022.870493

ISSN=1663-9812

ABSTRACT=Background: To date no oral antiviral drug has proven to be beneficial in hospitalized patients with COVID-19.

Methods: In this randomized, controlled, open label, platform trial we randomly assigned patients ≥18years hospitalized with COVID-19 pneumonia to receive either camostat mesylate (CM) (considered as standard-of-care) or lopinavir/ritonavir (LPV/RTV). The primary endpoint was time to sustained clinical improvement (≥48h) of at least one point on the 7-category WHO scale. Secondary endpoints included length of stay (LOS), need for mechanical ventilation (MV) or death, and 29-day mortality.

Results: 201 patients were included in the study (101 CM, 100 LPV/RTV) between April 20th 2020 and May 14th 2021. Mean age was 58.7 years, 67% were male. Median time from symptom onset to randomization was 7 days (IQR 5-9). 
Patients in the CM group had a significantly shorter time to sustained clinical improvement (HR= 0.67, 95%-CI 0.49-0.90; 9 vs. 11 days, p=0.008), demonstrated less progression to MV or death (6/101 [5.9%] vs. 15/100 [15%], p=0.036) and a shorter LOS (12 vs. 14 days, p=0.023).
A statistically non-significant trend towards a lower 29-day mortality in the CM group compared to the LPV/RTV group (2/101 [2%] vs. 7/100 [7%], p=0.089) was observed.

Conclusion: In patients hospitalized for COVID-19, use of CM was associated with a shorter time to clinical improvement, reduced need for MV or death and a shorter LOS compared to use of LPV/RTV. Further research is needed to confirm the efficacy of CM in larger placebo controlled trials.