The Impact of Camostat Mesilate on COVID-19 Infection

Phase 1

• Conditions: Corona Virus Infection
• Interventions: Drug: Placebo oral tablet; Drug: Camostat Mesilate

• Registration Number: NCT04321096
• Lead Sponsor: University of Aarhus

Brief Summary

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%.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-25
• Study Start: 2020-04-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30
• Primary Completion: 2022-01-31
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	2 pills 3 times daily for 5 days
Camostat Mesilate	Camostat Mesilate	2x100 mg pills 3 times daily for 5 days

Primary Outcome Measures

Name	Time	Method
Cohort 1: Days to clinical improvement from study enrolment	30 days	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
Cohort 2: Days to clinical improvement from study enrolment	30 days	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)

Secondary Outcome Measures

Name	Time	Method
Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30	30 days	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.
Cohort 1: Admission to ICU	30 days	ICU
Cohort 1: Day 30 mortality	30 days	Mortality
Cohort 1: Change in NEW(2) score from baseline to day 30	30 days	NEWS2
Cohort 1: Duration of supplemental oxygen (days)	30 days	Nasal or high-flow oxygen
Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30	30 days	Subjective clinical improvement
Cohort 2: Number participant-reported secondary infection of housemates	30 days	No of new COVID-19 infections in the household
Cohort 2: Time to hospital admission related to COVID-19 infection	30 days	Hospital admission
Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)	30 days
Cohort 1: Use of invasive mechanical ventilation or ECMO	30 days	invasive mechanical ventilation or ECMO

Trial Locations

Locations (11)

Region Hospital North Jutland; 🇩🇰 Hjørring, Region Nord, Denmark

Department of Infectious Diseases; 🇩🇰 Aalborg, Denmark

Department for Infectious Diseases, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Herning Regional Hospital; 🇩🇰 Herning, Denmark

Northzealands hospital - Hillerød; 🇩🇰 Hillerød, Denmark

Horsens Regional Hospital; 🇩🇰 Horsens, Denmark

Bispebjerg hospital; 🇩🇰 København, Denmark

Dept. of Infectious Diseases, Odense University Hospital; 🇩🇰 Odense, Denmark

Randers Regional Hospital; 🇩🇰 Randers, Denmark

Silkeborg Hospital; 🇩🇰 Silkeborg, Denmark

Örebro Hsopital; 🇸🇪 Örebro, Örebrolan, Sweden