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Region Hovedstaden - en del af Københavns Universitetshospital
E-pub ahead of print

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  • 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
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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. ClinicalTrials.gov Identifier: NCT04321096. EudraCT Number: 2020-001,200-42.

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 log10 copies/mL (p <0·05) and -0·82 log10 in the placebo group (P <0·05).

Interpretation: Under this protocol, camostat mesilate treatment was not associated with increased adverse events during hospitalization for Covid-19 and did not affect time to clinical improvement, progression to ICU admission or mortality.

OriginalsprogEngelsk
TidsskriftEClinicalMedicine
Sider (fra-til)100849
ISSN2589-5370
DOI
StatusE-pub ahead of print - 22 apr. 2021

ID: 65157655