Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-110 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Study Description
Connect with a study center
Region Hospital North Jutland
Hjørring, Region Nord
DenmarkActive - Recruiting
Department of Infectious Diseases
Aalborg,
DenmarkActive - Recruiting
Department for Infectious Diseases, Aarhus University Hospital
Aarhus N, 8200
DenmarkActive - Recruiting
Herning Regional Hospital
Herning, 7400
DenmarkActive - Recruiting
Northzealands hospital - Hillerød
Hillerød, 3400
DenmarkActive - Recruiting
Horsens Regional Hospital
Horsens, 8700
DenmarkActive - Recruiting
Bispebjerg hospital
København, 2400
DenmarkActive - Recruiting
Dept. of Infectious Diseases, Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
Randers Regional Hospital
Randers, 8900
DenmarkActive - Recruiting
Silkeborg Hospital
Silkeborg, 8600
DenmarkActive - Recruiting
Örebro Hsopital
Örebro, Örebrolan
SwedenActive - Recruiting
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