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  • Gunst, Jesper D.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)

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

  • Article/chapterEnglish2021

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  • Elsevier,2021
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:oru-91482
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-91482URI
  • https://doi.org/10.1016/j.eclinm.2021.100849DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

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  • Staerke, Nina B.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)
  • Pahus, Marie H.Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark (author)
  • Kristensen, Lena H.Deptarment of Medicine, Viborg Regional Hospital, Denmark (author)
  • Bodilsen, JacobDeptarment of Infectious Diseases, Aalborg University Hospital, Denmark (author)
  • Lohse, NicolaiDeptarment of Emergency Medicine, Copenhagen University Hospital, Hillerød, Denmark; Deptarment of Clinical Medicine, Copenhagen University, Copenhagen, Denmark (author)
  • Dalgaard, Lars S.Deptarment of Medicine, Regional Hospital West Jutland, Herning, Denmark (author)
  • Brønnum, DortheCentre for Clinical Research, North Denmark Regional Hospital, Hjoerring, Denmark (author)
  • Fröbert, Ole,1964-Örebro universitet,Institutionen för medicinska vetenskaper,Dept. of Cardiology(Swepub:oru)oft (author)
  • Hønge, BoDeptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Internal Medicine, Randers Regional Hospital, Randers, Denmark (author)
  • Johansen, Isik S.Research Unit for Infectious Diseases, Odense University Hospital, University of Southern Denmark, Denmark (author)
  • Monrad, IdaDeptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)
  • Erikstrup, ChristianDeptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Deptarment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark (author)
  • Rosendal, RegitzeDeptarment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark (author)
  • Vilstrup, EmilDeptarment of Medicine, Viborg Regional Hospital, Denmark (author)
  • Mariager, TheisDeptarment of Infectious Diseases, Aalborg University Hospital, Denmark (author)
  • Bove, Dorthe G.Deptarment of Emergency Medicine, Copenhagen University Hospital, Hillerød, Denmark (author)
  • Offersen, RasmusDeptarment of Medicine, Regional Hospital West Jutland, Herning, Denmark (author)
  • Shakar, ShakilDeptarment of Internal Medicine, North Denmark Regional Hospital, Denmark; Deptarment of Emergency Medicine, North Denmark Regional Hospital, Denmark (author)
  • Cajander, Sara,1980-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Deptarment of Infectious Diseases(Swepub:oru)scr (author)
  • Jørgensen, Nis P.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Internal Medicine, Randers Regional Hospital, Randers, Denmark (author)
  • Sritharan, Sajitha S.Deptarment of Medicine, Viborg Regional Hospital, Denmark (author)
  • Breining, PeterDeptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark (author)
  • Jespersen, SørenDeptarment of Emergency Medicine, Copenhagen University Hospital, Hillerød, Denmark (author)
  • Mortensen, Klaus L.Deptarment of Medicine, Regional Hospital West Jutland, Herning, Denmark (author)
  • Jensen, Mads L.Deptarment of Medicine, Viborg Regional Hospital, Denmark (author)
  • Kolte, LilianDeptarment of Lung and Infectious Diseases, Copenhagen University Hospital, Hillerød, Denmark (author)
  • Frattari, Giacomo S.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)
  • Larsen, Carsten S.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)
  • Storgaard, MereteDeptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)
  • Nielsen, Lars P.Deptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Biomedicine, Aarhus University, Aarhus, Denmark (author)
  • Tolstrup, MartinDeptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark (author)
  • Sædder, Eva A.Deptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Biomedicine, Aarhus University, Aarhus, Denmark (author)
  • Østergaard, Lars J.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark (author)
  • Ngo, Hien T. T.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)
  • Jensen, Morten H.Deptarment of Health Science and Technology, Aalborg University, Aalborg, Denmark; Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark (author)
  • Højen, Jesper F.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (author)
  • Kjolby, MadsDeptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark; DANDRITE, Deptarment of Biomedicine, Aarhus University, Aarhus Denmark; Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark; University of Dundee, Scotland, United Kingdom (author)
  • Søgaard, Ole S.Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark (author)
  • Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, DenmarkDeptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark (creator_code:org_t)

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  • In:eClinicalMedicine: Elsevier352589-5370

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