COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04321096

Ole S Søgaard, MD PhD

olesoega@rm.dk

2020-03-25

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

None

2

University of Aarhus

18

110

Denmark;Sweden

No restriction on type of patients

0: No restriction on type of patients

580

Cohort 1: Days to clinical improvement from study enrolment;Cohort 2: Days to clinical improvement from study enrolment

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]