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

Primary Purpose

Corona Virus Infection

Status

Unknown status

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Camostat Mesilate

Placebo oral tablet

About this trial

This is an interventional treatment trial for Corona Virus Infection focused on measuring COVID-19, SARS-CoV-2

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Region Hospital North JutlandRecruiting
Department of Infectious DiseasesRecruiting
Department for Infectious Diseases, Aarhus University HospitalRecruiting
Herning Regional HospitalRecruiting
Northzealands hospital - HillerødRecruiting
Horsens Regional HospitalRecruiting
Bispebjerg hospitalRecruiting
Dept. of Infectious Diseases, Odense University HospitalRecruiting
Randers Regional HospitalRecruiting
Silkeborg HospitalRecruiting
Örebro HsopitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Camostat Mesilate

Arm Description

2 pills 3 times daily for 5 days

2x100 mg pills 3 times daily for 5 days

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

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

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.

Cohort 1: Day 30 mortality

Mortality

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

NEWS2

Cohort 1: Admission to ICU

ICU

Cohort 1: Use of invasive mechanical ventilation or ECMO

invasive mechanical ventilation or ECMO

Cohort 1: Duration of supplemental oxygen (days)

Nasal or high-flow oxygen

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

Cohort 2: Number participant-reported secondary infection of housemates

No of new COVID-19 infections in the household

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

Hospital admission

Full Information

NCT ID

NCT04321096

First Posted

March 23, 2020

Last Updated

April 27, 2021

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT04321096

Brief Title

The Impact of Camostat Mesilate on COVID-19 Infection

Acronym

CamoCO-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 4, 2020 (Actual)

Primary Completion Date

January 31, 2022 (Anticipated)

Study Completion Date

May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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%.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corona Virus Infection

Keywords

COVID-19, SARS-CoV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Placebo-controlled

Allocation

Randomized

Enrollment

580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2 pills 3 times daily for 5 days

Arm Title

Camostat Mesilate

Arm Type

Experimental

Arm Description

2x100 mg pills 3 times daily for 5 days

Intervention Type

Drug

Intervention Name(s)

Camostat Mesilate

Other Intervention Name(s)

Foipan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Other Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

30 days

Title

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

Description

Time Frame

30 days

Title

Cohort 1: Day 30 mortality

Description

Mortality

Time Frame

30 days

Title

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

Description

NEWS2

Time Frame

30 days

Title

Cohort 1: Admission to ICU

Description

ICU

Time Frame

30 days

Title

Cohort 1: Use of invasive mechanical ventilation or ECMO

Description

invasive mechanical ventilation or ECMO

Time Frame

30 days

Title

Cohort 1: Duration of supplemental oxygen (days)

Description

Nasal or high-flow oxygen

Time Frame

30 days

Title

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

Title

Cohort 2: Number participant-reported secondary infection of housemates

Description

No of new COVID-19 infections in the household

Time Frame

30 days

Title

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

Description

Hospital admission

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

110 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ole S Søgaard, MD PhD

Phone

+45 2499 4962

olesoega@rm.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Østergaard, Professor

Organizational Affiliation

Head of Department

Official's Role

Study Chair

Facility Information:

Facility Name

Region Hospital North Jutland

City

Hjørring

State/Province

Region Nord

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Leutscher

p.leutscher@rn.dk

Facility Name

Department of Infectious Diseases

City

Aalborg

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacob Bodilsen

Facility Name

Department for Infectious Diseases, Aarhus University Hospital

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ole S Søgaard, MD, PhD

Phone

+45 2499 4962

olesoega@rm.dk

First Name & Middle Initial & Last Name & Degree

Ole S Soegaard, MD, PhD

Facility Name

Herning Regional Hospital

City

Herning

ZIP/Postal Code

7400

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lars S Dalgaard, MD

Facility Name

Northzealands hospital - Hillerød

City

Hillerød

ZIP/Postal Code

3400

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolai L Lohse, MD

Facility Name

Horsens Regional Hospital

City

Horsens

ZIP/Postal Code

8700

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayfer Topcu, MD

Facility Name

Bispebjerg hospital

City

København

ZIP/Postal Code

2400

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stine Johnsen, MD

Facility Name

Dept. of Infectious Diseases, Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isik S. Johansen, MD

Facility Name

Randers Regional Hospital

City

Randers

ZIP/Postal Code

8900

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bo Hønge, MD

Facility Name

Silkeborg Hospital

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Britta Tarp, MD

Facility Name

Örebro Hsopital

City

Örebro

State/Province

Örebrolan

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Cajandar, MD

sara.cajander@regionorebrolan.se

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

Citations:

PubMed Identifier

33903855

Citation

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.

Results Reference

derived

Learn more about this trial

The Impact of Camostat Mesilate on COVID-19 Infection

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