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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Efficacy of the TMPRSS2 inhibitor camostat mesilate in patients hospitalized with Covid-19-a double-blind randomized controlled trial.
eClinicalMedicine, Volume 35, Article 100849, Year 2021
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Description
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 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. ClinicalTrials.gov Identifier: NCT04321096. EudraCT Number: 2020-001200-42. © 2021 The Authors
Authors & Co-Authors
Gunst, Jesper Damsgaard
Denmark, Aarhus
Aarhus Universitetshospital
Stærke, Nina Breinholt
Denmark, Aarhus
Aarhus Universitetshospital
Brønnum, Dorthe Scavenius
Denmark, Hjorring
North Denmark Regional Hospital
Frob̈ert, Ole
Sweden, Orebro
Örebro Universitet
Langhoff Hønge, Bo
Denmark, Aarhus
Aarhus Universitetshospital
Denmark, Randers
Regionshospitalet Randers
Johansen, I. S.
Denmark, Odense
Syddansk Universitet
Erikstrup, Christian
Denmark, Aarhus
Aarhus Universitet
Denmark, Aarhus
Aarhus Universitetshospital
Jørgensen, Nis Pedersen Pedersen
Denmark, Aarhus
Aarhus Universitetshospital
Denmark, Randers
Regionshospitalet Randers
Larsen, Carsten Schade
Denmark, Aarhus
Aarhus Universitetshospital
Storgaard, Merete
Denmark, Aarhus
Aarhus Universitetshospital
Tolstrup, Martin
Denmark, Aarhus
Aarhus Universitetshospital
Denmark, Aarhus
Aarhus Universitet
Østergaard, Lars Jørgen
Denmark, Aarhus
Aarhus Universitetshospital
Denmark, Aarhus
Aarhus Universitet
Søgaard, Ole S.
Denmark, Aarhus
Aarhus Universitetshospital
Denmark, Aarhus
Aarhus Universitet
Statistics
Citations: 118
Authors: 13
Affiliations: 14
Identifiers
Doi:
10.1016/j.eclinm.2021.100849
ISSN:
25895370
Research Areas
Covid
Disability
Environmental
Study Approach
Quantitative