The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial
Latest Information Update: 05 Apr 2023
At a glance
- Drugs Camostat mesilate (Primary)
- Indications COVID 2019 infections; Severe acute respiratory syndrome
- Focus Therapeutic Use
- Acronyms CamoCO-19
- 05 Oct 2021 This trial has been Discontinued in Denmark, according to European Clinical Trials Database record.
- 27 Apr 2021 Status changed from active, no longer recruiting to recruiting.
- 27 Apr 2021 Planned End Date changed from 1 May 2021 to 1 May 2022.
Most Recent Events
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 | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04321096 | nuclear receptor subfamily 1 group I member 2 | Outcome Measure |
sarcosine dehydrogenase | Outcome Measure |
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
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Initiation Dates
Planned : 31 Mar 2020
Actual : 04 Apr 2020
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Primary Completion Dates
Planned : 31 Jan 2022
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End Dates
Planned : 01 May 2022
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase I/II
- Location Denmark; Sweden
- 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 |
---|---|---|
Ayfer Topcu, MD | Horsens Regional Hospital | Denmark |
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 |
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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
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Ole S Søgaard, MD, PhD
+45 2499 4962 olesoega@rm.dk
show details
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Department for Infectious Diseases, Aarhus University Hospital | Denmark |
Ole Schmeltz SØgaard
Palle Juul-Jensens Boulevard 45
show details
Aarhus N Postcode: 8200 Denmark Telephone: 004523886636 olesoega@rm.dk |
Department of Infecitous Diseases, Aarhus University Hospital | Denmark |
Peter Leutscher
p.leutscher@rn.dk
show details
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Region Hospital North Jutland | Denmark |
Sara Cajandar, MD
sara.cajander@regionorebrolan.se
show details
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Örebro Hsopital | Sweden |
Stine Johnsen, MD | Bispebjerg hospital | Denmark |
Centres
Centre Name | Location | Trial Centre Country |
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- |
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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 |
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Herning Regional Hospital | Herning | Denmark |
Horsens Regional Hospital | Horsens | Denmark |
Northzealands hospital - Hillerød | Hillerød | Denmark |
Randers Regional Hospital | Randers | Denmark |
Region Hospital North Jutland | Hjørring, Region Nord | Denmark |
Silkeborg Hospital | Silkeborg | Denmark |
Örebro Hsopital | Örebro, Örebrolan | Sweden |
Trial History
Event Date | Event Type | Comment |
---|---|---|
05 Apr 2023 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Apr 2021). Updated 05 Apr 2023 |
05 Apr 2023 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 05 Apr 2023 |
06 Oct 2021 | Other trial event | Last checked against European Clinical Trials Database. Updated 06 Oct 2021 |
05 Oct 2021 | Other trial event | This trial has been Discontinued in Denmark, according to European Clinical Trials Database record. Updated 06 Oct 2021 |
30 Apr 2021 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
27 Apr 2021 | Status change - recruiting | Status changed from active, no longer recruiting to recruiting. Updated 04 May 2021 |
27 Apr 2021 | Completion date | Planned End Date changed from 1 May 2021 to 1 May 2022. Updated 04 May 2021 |
27 Apr 2021 | Other trial event | Planned primary completion date changed from 31 Jan 2021 to 31 Jan 2022. Updated 04 May 2021 |
15 Jan 2021 | Other trial event | Planned primary completion date changed from 31 Dec 2020 to 31 Jan 2021. Updated 20 Jan 2021 |
15 Jan 2021 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 20 Jan 2021 |
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
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
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 -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu
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