Efficacy of the TMPRSS2 inhibitor camostat mesilate in patients hospitalized with Covid-19-a double-blind randomized controlled trial

Jesper D Gunst, Nina B Staerke, Marie H Pahus, Lena H Kristensen, Jacob Bodilsen, Nicolai Lohse, Lars S Dalgaard, Dorthe Brønnum, Ole Fröbert, Bo Hønge, Isik S Johansen, Ida Monrad, Christian Erikstrup, Regitze Rosendal, Emil Vilstrup, Theis Mariager, Dorthe G Bove, Rasmus Offersen, Shakil Shakar, Sara CajanderNis P Jørgensen, Sajitha S Sritharan, Peter Breining, Søren Jespersen, Klaus L Mortensen, Mads L Jensen, Lilian Kolte, Giacomo S Frattari, Carsten S Larsen, Merete Storgaard, Lars P Nielsen, Martin Tolstrup, Eva A Sædder, Lars J Østergaard, Hien T T Ngo, Morten H Jensen, Jesper F Højen, Mads Kjolby, Ole S Søgaard

Publikation: Bidrag til tidsskriftTidsskriftsartikelForskningpeer review


Background: The trans-membrane protease serine 2 (TMPRSS2) is essential for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cell entry and infection. Efficacy and safety of TMPRSS2 inhibitors in patients with coronavirus disease 2019 (Covid-19) have not been evaluated in randomized trials.Methods: We conducted an investigator-initiated, double-blind, randomized, placebo-controlled multicenter trial in patients hospitalized with confirmed SARS-CoV-2 infection from April 4, to December 31, 2020. Within 48 h of admission, participants were randomly assigned in a 2:1 ratio to receive the TMPRSS2 inhibitor camostat mesilate 200 mg three times daily for 5 days or placebo. The primary outcome was time to discharge or clinical improvement measured as ≥2 points improvement on a 7-point ordinal scale. Other outcomes included 30-day mortality, safety and change in oropharyngeal viral load.Findings: 137 patients were assigned to receive camostat mesilate and 68 to placebo. Median time to clinical improvement was 5 days (interquartile range [IQR], 3 to 7) in the camostat group and 5 days (IQR, 2 to 10) in the placebo group ( P = 0·31). The hazard ratio for 30-day mortality in the camostat compared with the placebo group was 0·82 (95% confidence interval [CI], 0·24 to 2·79; P = 0·75). The frequency of adverse events was similar in the two groups. Median change in viral load from baseline to day 5 in the camostat group was -0·22 log 10 copies/mL ( p
StatusUdgivet - maj 2021
Udgivet eksterntJa