Effect of Camostat Mesilate on individuals with COVID-19 infectio

Phase 1

• Conditions: 2019-nCoV acute respiratory disease; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2020-001200-42-DK
• Lead Sponsor: Department of Infecitous Diseases, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Cohort 1:
1) Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical assay) for SARS-CoV-2
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
3) Adolescents and adults age >=18 years
4) Subject or legally authorized representative able to give informed consent
5) Admitted to hospital

Cohort 2:
1) Documented COVID-19 infection as evidenced by positive PCR (or comparable clinical assay) for SARS-CoV-2
2) One or more of the following symptoms of COVID-19 infection: fever, cough, expectoration, shortness of breath, myalgia, fatigue, or head ache
3) No more than 5 days since the beginning of symptom onset
4) Adolescents and adults age >=18 years
5) Subject or legally authorized representative able to give informed consent
6) Do not require immediate hospitalization (newly diagnosed COVID-19 patients who are discharged within 24 hrs of hospital admission are eligible for enrollment)
7) Must be willing to fill out a daily symptom diary
8) Must be available for a daily phone call
9) Must be willing to take their own temperature at least twice a day

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 335
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

1) Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy
2) The following laboratory values at baseline (Day 0):
oSerum total bilirubin =3 ULN
oEstimated glomerular filtration rate (eGFR) =30 mL/min (based on serum creatinine)
3) Known hypersensitivity to Camostat Mesilate
4) 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.

* Women are considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy (According to the Clinical Trial Facilitation Group, 2014-09-15).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified