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The Impact of Camostat Mesilate on COVID-19 Infection (CamoCO-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321096
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
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%.


Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Camostat Mesilate Drug: Placebo oral tablet Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo-controlled
Primary Purpose: Treatment
Official Title: The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial
Actual Study Start Date : April 4, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
2 pills 3 times daily for 5 days
Drug: Placebo oral tablet
Placebo
Other Name: Placebo

Experimental: Camostat Mesilate
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
Other Name: Foipan




Primary Outcome Measures :
  1. Cohort 1: Days to clinical improvement from study enrolment [ Time Frame: 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

  2. Cohort 2: Days to clinical improvement from study enrolment [ Time Frame: 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 :
  1. Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs) [ Time Frame: 30 days ]
  2. Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30 [ Time Frame: 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.

  3. Cohort 1: Day 30 mortality [ Time Frame: 30 days ]
    Mortality

  4. Cohort 1: Change in NEW(2) score from baseline to day 30 [ Time Frame: 30 days ]
    NEWS2

  5. Cohort 1: Admission to ICU [ Time Frame: 30 days ]
    ICU

  6. Cohort 1: Use of invasive mechanical ventilation or ECMO [ Time Frame: 30 days ]
    invasive mechanical ventilation or ECMO

  7. Cohort 1: Duration of supplemental oxygen (days) [ Time Frame: 30 days ]
    Nasal or high-flow oxygen

  8. Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]
    Subjective clinical improvement

  9. Cohort 2: Number participant-reported secondary infection of housemates [ Time Frame: 30 days ]
    No of new COVID-19 infections in the household

  10. Cohort 2: Time to hospital admission related to COVID-19 infection [ Time Frame: 30 days ]
    Hospital admission



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Cohort 1)

  • Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical assay) for SARS-CoV-2
  • Less than 48 hours since time of hospital admission OR if hospital-acquired COVID-19 is suspected, less than 48 hrs since onset of symptoms
  • Adolescents and adults age >=18 years
  • Subject or legally authorized representative able to give informed consent
  • Admitted to hospital

Cohort 2)

  • Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical assay) for SARS-CoV-2
  • One or more of the following symptoms of COVID-19 infection: fever, cough, expectoration, shortness of breath, myalgia, fatigue, or head ache
  • No more than 5 days since the beginning of symptom onset
  • Adolescents and adults age >=18 years
  • Subject (or legally authorized representative, for Cohort 1 only) able to give informed consent
  • Do not require immediate hospitalization (newly diagnosed COVID-19 patients who are discharged within 24 hrs of hospital admission are eligible for enrollment)
  • 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

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321096


Contacts
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Contact: Ole S Søgaard, MD PhD +45 2499 4962 olesoega@rm.dk

Locations
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Denmark
Department of Infectious Diseases Recruiting
Aalborg, Denmark
Contact: Jacob Bodilsen         
Department for Infectious Diseases, Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Ole S Søgaard, MD, PhD    +45 2499 4962    olesoega@rm.dk   
Principal Investigator: Ole S Soegaard, MD, PhD         
Herning Regional Hospital Recruiting
Herning, Denmark, 7400
Contact: Lars S Dalgaard, MD         
Northzealands hospital - Hillerød Recruiting
Hillerød, Denmark, 3400
Contact: Nicolai L Lohse, MD         
Horsens Regional Hospital Recruiting
Horsens, Denmark, 8700
Contact: Ayfer Topcu, MD         
Bispebjerg hospital Recruiting
København, Denmark, 2400
Contact: Stine Johnsen, MD         
Dept. of Infectious Diseases, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Isik S. Johansen, MD         
Randers Regional Hospital Recruiting
Randers, Denmark, 8900
Contact: Bo Hønge, MD         
Silkeborg Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Britta Tarp, MD         
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Chair: Lars Østergaard, Professor Head of Department
Additional Information:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04321096    
Other Study ID Numbers: 2020-001200-42
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Camostat
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors