The Impact of Camostat Mesilate on COVID-19 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-04

Study Completion Date

2023-05-01

Brief Summary

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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%.

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Detailed Description

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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

Conditions

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Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are 2 cohorts: Cohort 1 - hospitalized patients (n=180); Cohort 2 - outpatients (n=400). All participants in the two cohorts are randomized to one of two arms

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Placebo-controlled

Study Groups

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Placebo

2 pills 3 times daily for 5 days

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo

Camostat Mesilate

2x100 mg pills 3 times daily for 5 days

Group Type EXPERIMENTAL

Camostat Mesilate

Intervention Type DRUG

Serine protease inhibitor that blocks TMPRSS-2 mediated cell entry of SARS-CoV-2

Interventions

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Camostat Mesilate

Serine protease inhibitor that blocks TMPRSS-2 mediated cell entry of SARS-CoV-2

Intervention Type DRUG

Placebo oral tablet

Placebo

Intervention Type DRUG

Other Intervention Names

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Foipan Placebo

Eligibility Criteria

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Inclusion Criteria

* Must be willing to fill out a daily symptom diary
* Must be available for a daily phone call
* Must be willing to take their own temperature at least once a day

Exclusion Criteria

* The following laboratory values at baseline (Day 0):

* Serum total bilirubin ≥3 ULN
* Estimated glomerular filtration rate (eGFR) ≤30 mL/min (based on serum creatinine)
* Known hypersensitivity to Camostat Mesilate
* Women who are pregnant or breastfeeding, or with a positive pregnancy test as determined by a positive urine or blood beta- human chorionic gonadotropin test during screening or women of child bearing potential\* who are unwilling or unable to use an acceptable method of contraception (combined estrogen and progestogen hormonal contraception (oral, intravaginal or transdermal), progesteron-only hormonal contraception (oral, injectable or implantable), intrauterine device or intrauterine hormone-releasing system) to avoid pregnancy during the study. Sexual abstinence will only be accepted in cases where this reflect the usual lifestyle.

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No