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Recent:   

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

Gunst et al., eClinicalMedicine, doi:10.1016/j.eclinm.2021.100849, CamoCO-19, NCT04321096
May 2021  
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Mortality 18% Improvement Relative Risk Ventilation 31% ICU admission 20% Recovery 15% Camostat  CamoCO-19  LATE TREATMENT  DB RCT Is late treatment with camostat beneficial for COVID-19? Double-blind RCT 205 patients in Denmark (April - December 2020) Improved recovery with camostat (not stat. sig., p=0.28) c19early.org Gunst et al., eClinicalMedicine, May 2021 Favorscamostat Favorscontrol 0 0.5 1 1.5 2+
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.
risk of death, 18.0% lower, HR 0.82, p = 0.75, treatment 8 of 137 (5.8%), control 4 of 68 (5.9%), Cox proportional hazards.
risk of mechanical ventilation, 31.0% lower, HR 0.69, p = 0.65, treatment 13 of 137 (9.5%), control 3 of 68 (4.4%), Cox proportional hazards.
risk of ICU admission, 20.0% lower, HR 0.80, p = 0.61, treatment 14 of 137 (10.2%), control 8 of 68 (11.8%), NNT 65, adjusted per study, multivariable, Cox proportional hazards.
risk of no recovery, 15.3% lower, HR 0.85, p = 0.28, treatment 137, control 68, adjusted per study, inverted to make HR<1 favor treatment, multivariable, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gunst et al., 31 May 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Denmark, peer-reviewed, median age 61.0, 39 authors, study period 4 April, 2020 - 31 December, 2020, trial NCT04321096 (history) (CamoCO-19). Contact: mads@dandrite.au.dk, olesoega@rm.dk.
This PaperMiscellaneousAll
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 Cajander, Nis 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
EClinicalMedicine, doi:10.1016/j.eclinm.2021.100849
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.
Supplementary materials Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.eclinm.2021.100849.
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Late treatment
is less effective
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