The Impact of Camostat Mesilate on COVID-19 Infection
CamoCO-19
1 other identifier
interventional
206
2 countries
11
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2020
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
April 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedApril 18, 2025
April 1, 2022
1.8 years
March 23, 2020
April 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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)
30 days
Secondary Outcomes (10)
Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)
30 days
Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30
30 days
Cohort 1: Day 30 mortality
30 days
Cohort 1: Change in NEW(2) score from baseline to day 30
30 days
Cohort 1: Admission to ICU
30 days
- +5 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR2 pills 3 times daily for 5 days
Camostat Mesilate
EXPERIMENTAL2x100 mg pills 3 times daily for 5 days
Interventions
Serine protease inhibitor that blocks TMPRSS-2 mediated cell entry of SARS-CoV-2
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Region Hospital North Jutland
Hjørring, Region Nord, Denmark
Department of Infectious Diseases
Aalborg, Denmark
Department for Infectious Diseases, Aarhus University Hospital
Aarhus N, 8200, Denmark
Bispebjerg hospital
Copenhagen, 2400, Denmark
Herning Regional Hospital
Herning, 7400, Denmark
Northzealands hospital - Hillerød
Hillerød, 3400, Denmark
Horsens Regional Hospital
Horsens, 8700, Denmark
Dept. of Infectious Diseases, Odense University Hospital
Odense, 5000, Denmark
Randers Regional Hospital
Randers, 8900, Denmark
Silkeborg Hospital
Silkeborg, 8600, Denmark
Örebro Hsopital
Örebro, Örebrolan, Sweden
Related Publications (1)
Gunst JD, Staerke NB, Pahus MH, Kristensen LH, Bodilsen J, Lohse N, Dalgaard LS, Bronnum D, Frobert O, Honge B, Johansen IS, Monrad I, Erikstrup C, Rosendal R, Vilstrup E, Mariager T, Bove DG, Offersen R, Shakar S, Cajander S, Jorgensen NP, Sritharan SS, Breining P, Jespersen S, Mortensen KL, Jensen ML, Kolte L, Frattari GS, Larsen CS, Storgaard M, Nielsen LP, Tolstrup M, Saedder EA, Ostergaard LJ, Ngo HTT, Jensen MH, Hojen JF, Kjolby M, Sogaard OS. Efficacy of the TMPRSS2 inhibitor camostat mesilate in patients hospitalized with Covid-19-a double-blind randomized controlled trial. EClinicalMedicine. 2021 May;35:100849. doi: 10.1016/j.eclinm.2021.100849. Epub 2021 Apr 22.
PMID: 33903855DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lars Østergaard, Professor
Head of Department
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Placebo-controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
April 4, 2020
Primary Completion
January 31, 2022
Study Completion
May 1, 2023
Last Updated
April 18, 2025
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Access Criteria
- Access to the data sharing will be given to researchers who provide a methodologically sound proposal for any type of analysis and requires IRB/Ethics committee approval (if applicable). Proposals should be addressed to olesoega@rm.dk.
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.