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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 04 May 2020

At a glance

  • Drugs Camostat mesilate (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Therapeutic Use
  • Acronyms CamoCO-19
  • Most Recent Events

    • 28 Apr 2020 Planned number of patients changed from 180 to 580.
    • 02 Apr 2020 Status changed from not yet recruiting to recruiting.
    • 02 Apr 2020 New trial record

Trial Overview

Purpose

The overall objective of the study is to evaluate the efficacy of Camostat Mesilate against COVID-19 infection among adults hospitalized with COVID-19 infection.

Primary Endpoints

Cohort 1: Days to clinical improvement from study enrolment

description: 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
time_frame: 30 days

Cohort 2: Days to clinical improvement from study enrolment

description: 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)
time_frame: 30 days

Other Endpoints

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

time_frame: 30 days

Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30

description: 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.
time_frame: 30 days

Cohort 1: Day 30 mortality

description: Mortality
time_frame: 30 days

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

description: NEWS2
time_frame: 30 days

Cohort 1: Admission to ICU

description: ICU
time_frame: 30 days

Cohort 1: Use of invasive mechanical ventilation or ECMO

description: invasive mechanical ventilation or ECMO
time_frame: 30 days

Cohort 1: Duration of supplemental oxygen (days)

description: Nasal or high-flow oxygen
time_frame: 30 days

Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30

description: Subjective clinical improvement
time_frame: 30 days

Cohort 2: Number participant-reported secondary infection of housemates

description: No of new COVID-19 infections in the household
time_frame: 30 days

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

description: Hospital admission
time_frame: 30 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 580

  • Sex male & female
  • Age Group 18-110 years; adult; elderly

Patient Inclusion 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

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04321096 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001200-42 European Clinical Trials Database
CamoCO19-001 -

Trial Dates

  • Initiation Dates

    Planned : 31 Mar 2020

    Actual : 04 Apr 2020

  • Primary Completion Dates

    Planned : 31 Dec 2020

  • End Dates

    Planned : 01 May 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Denmark
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Camostat mesilatePrimary Drug Oral Tablet

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

Placebo

2 pills 3 times daily for 5 days
Drug: Placebo oral tablet (Placebo) Other Name: Placebo

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Bo Hønge, MD Randers Regional Hospital Denmark
Britta Tarp, MD Silkeborg Hospital Denmark
Isik S. Johansen, MD Dept. of Infectious Diseases, Odense University Hospital Denmark
Jacob Bodilsen Department of Infectious Diseases Denmark
Lars S Dalgaard, MD Herning Regional Hospital Denmark
Lars Østergaard, Professor Head of Department
-
Nicolai L Lohse, MD Northzealands hospital - Hillerød Denmark
Ole S Soegaard, MD, PhD Department for Infectious Diseases, Aarhus University Hospital Denmark
Ole S Søgaard, MD PhD
+45 2499 4962 olesoega@rm.dk
show details
-
Ole S Søgaard, MD, PhD
+45 2499 4962 olesoega@rm.dk
show details
Department for Infectious Diseases, Aarhus University Hospital Denmark
Ole Schmeltz SØgaard
Palle Juul-Jensens Boulevard 45
Aarhus N
Postcode: 8200
Denmark
Telephone: 004523886636
olesoega@rm.dk
show details
Department of Infecitous Diseases, Aarhus University Hospital Denmark
Stine Johnsen, MD Bispebjerg hospital Denmark
Ulf G Hørlyk, MD Horsens Regional Hospital Denmark

Centres

Centre Name Location Trial Centre Country
-
-
-
Bispebjerg hospital København Denmark
Department for Infectious Diseases, Aarhus University Hospital Aarhus N Denmark
Department of Infecitous Diseases, Aarhus University Hospital Aarhus N Denmark
Department of Infectious Diseases Aalborg Denmark
Dept. of Infectious Diseases, Odense University Hospital Odense Denmark
Head of Department
-
-
Herning Regional Hospital Herning Denmark
Horsens Regional Hospital Horsens Denmark
Northzealands hospital - Hillerød Hillerød Denmark
Randers Regional Hospital Randers Denmark
Silkeborg Hospital Silkeborg Denmark

Trial History

Event Date Event Type Comment
04 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 04 May 2020
28 Apr 2020 Other trial event Last checked against European Clinical Trials Database. Updated 28 Apr 2020
28 Apr 2020 Other trial event Planned number of patients changed from 180 to 580. Updated 28 Apr 2020
07 Apr 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04321096). Updated 07 Apr 2020
02 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 07 Apr 2020
02 Apr 2020 New trial record New trial record Updated 02 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Corti R, Fuster V, Fayad ZA, Worthley SG, Helft G, Chaplin WF, et al. Effects of aggressive versus conventional lipid-lowering therapy by simvastatin on human atherosclerotic lesions: a prospective, randomized, double-blind trial with high-resolution magnetic resonance imaging. J-Am-Coll-Cardiol 2005;46(1):106-112.

    PubMed | CrossRef Fulltext
  3. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
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