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Corona Virus InfectionPhase 1/2CamoCO-19NCT04321096

The Impact of Camostat Mesilate on COVID-19 Infection

A Phase 1/2 study testing Camostat Mesilate in people with Corona Virus Infection, run by University of Aarhus at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Corona Virus Infection
What is being tested?
Camostat Mesilate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
11 sitesin 2 countries
Study dates
4 Apr 2020to 1 May 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy (e.g. the patient is considered to be moribund within the next 72 hrs or has uncontrolled substance abuse that prevents adherence to study medication). Patients needing ventilator treatment are eligible to be enrolled if they fulfill the other in/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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Denmark10 sites

  • Department of Infectious Diseases

    Aalborg

  • Department for Infectious Diseases, Aarhus University Hospital

    Aarhus N, 8200

  • Bispebjerg hospital

    Copenhagen, 2400

  • Herning Regional Hospital

    Herning, 7400

  • Northzealands hospital - Hillerød

    Hillerød, 3400

  • Region Hospital North Jutland

    Hjørring, Region Nord

  • Horsens Regional Hospital

    Horsens, 8700

  • Dept. of Infectious Diseases, Odense University Hospital

    Odense, 5000

  • Randers Regional Hospital

    Randers, 8900

  • Silkeborg Hospital

    Silkeborg, 8600

Other trials in Denmark

Sweden1 site

  • Örebro Hsopital

    Örebro, Örebrolan

Other trials in Sweden

About this study

Official title: The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial

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%.

Read the 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

Being tested
Camostat Mesilate, Placebo oral tablet
Keywords
COVID-19, SARS-CoV-2
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camostat MesilateDrug

    Also called Foipan

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

  • Placebo oral tabletDrug

    Also called Placebo

    Placebo

Study groups in NCT04321096
Study groupRoleWhat they receive
PlaceboPlacebo comparator2 pills 3 times daily for 5 days
Receives: Drug: Placebo oral tablet
Camostat MesilateExperimental2x100 mg pills 3 times daily for 5 days
Receives: Drug: Camostat Mesilate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days

  2. 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)

    Measured: 30 days

Secondary outcomes (10)

  1. Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)

    Measured: 30 days

  2. 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.

    Measured: 30 days

  3. Cohort 1: Day 30 mortality

    Mortality

    Measured: 30 days

  4. Cohort 1: Change in NEW(2) score from baseline to day 30

    NEWS2

    Measured: 30 days

  5. Cohort 1: Admission to ICU

    ICU

    Measured: 30 days

  6. Cohort 1: Use of invasive mechanical ventilation or ECMO

    invasive mechanical ventilation or ECMO

    Measured: 30 days

  7. Cohort 1: Duration of supplemental oxygen (days)

    Nasal or high-flow oxygen

    Measured: 30 days

  8. 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

    Measured: 30 days

  9. Cohort 2: Number participant-reported secondary infection of housemates

    No of new COVID-19 infections in the household

    Measured: 30 days

  10. Cohort 2: Time to hospital admission related to COVID-19 infection

    Hospital admission

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start4 Apr 2020
  3. Primary completion31 Jan 2022
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321096
Sponsor's protocol ID
2020-001200-42
Acronym
CamoCO-19
Status last verified
Apr 2022
First submitted
23 Mar 2020
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 33903855

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Camostat Mesilate in people with Corona Virus Infection, run by University of Aarhus at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Days to clinical improvement from study enrolment (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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