A Phase 1/2 interventional study of Camostat Mesilate and Placebo oral tablet in Corona Virus Infection, sponsored by University of Aarhus. Completed at 11 sites in 2 countries. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by University of Aarhus · Phase 1/2, Interventional, and Treatment
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment.
SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.
Cohort 1 - enrolment into the cohort of hospitalized patients has been completed (31 Dec 2020). Study results are publicly available at EClinicilMedicine, see link https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00129-2/fulltext Cohort 2 - outpatients - remains open for enrolment
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 206 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort 1)
Cohort 2)
Exclusion criteria
The following laboratory values at baseline (Day 0):
2 pills 3 times daily for 5 days
Drug: Placebo oral tablet
2x100 mg pills 3 times daily for 5 days
Drug: Camostat Mesilate
Serine protease inhibitor that blocks TMPRSS-2 mediated cell entry of SARS-CoV-2
Also known as: Foipan
Placebo
Also known as: Placebo
Cohort 1: Days to clinical improvement from study enrolment
Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale
Time frame: 30 days
Cohort 2: Days to clinical improvement from study enrolment
Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)
Time frame: 30 days
Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)
Time frame: 30 days
Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Time frame: 30 days
Cohort 1: Day 30 mortality
Mortality
Time frame: 30 days
Cohort 1: Change in NEW(2) score from baseline to day 30
NEWS2
Time frame: 30 days
Cohort 1: Admission to ICU
ICU
Time frame: 30 days
Cohort 1: Use of invasive mechanical ventilation or ECMO
invasive mechanical ventilation or ECMO
Time frame: 30 days
Cohort 1: Duration of supplemental oxygen (days)
Nasal or high-flow oxygen
Time frame: 30 days
Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30
Subjective clinical improvement
Time frame: 30 days
Cohort 2: Number participant-reported secondary infection of housemates
No of new COVID-19 infections in the household
Time frame: 30 days
Cohort 2: Time to hospital admission related to COVID-19 infection
Hospital admission
Time frame: 30 days
Plan to share: Yes — Data sharing plan: Individual deidentified participant data (including data dictionaries) will be shared following the publication of the primary and secondary endpoints as outlined in this protocol. Data to be shared includes deidentified data points in published, peer-reviewed articles. Additional, related documents will also be available (study protocol, informed consent form, statistical analysis plan). Data will become available following publication with no planned end date.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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University of Aarhus