Efficacy and Safety of Edoxaban and or Colchicine for patients with SARS-CoV-2 infection managed in the out of hospital setting (COVID 19)

Phase 1

• Conditions: Patients = 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002234-32-BE
• Lead Sponsor: Insel Gruppe AG - Bern University Hospital, Department of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-26
• Study Completion: 2022-08-31
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients = 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

•Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including Child-Pugh C cirrhosis with portal hypertension.
•Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
•Uncontrolled severe hypertension.
•Ongoing or planned treatment with parenteral or oral anticoagulants
•Unilateral or bilateral above knee lower extremity amputation.
•Inability to take oral medication or otherwise unable or unwilling to undergo/perform study-specified procedures
•Have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
•Pregnancy or breast-feeding or any plan to become pregnant during the study. Women (and men, for Colchicine group only) with child-bearing potential not using adequate birth control method (note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible, both partners should use adequate barrier birth control).
•Need for dual anti-platelet therapy consisting of aspirin and an oral P2Y12 inhibitor
•Inflammatory bowel disease or chronic diarrhea or neuromuscular disease
•Creatinine clearance (CrCl) <15 ml/min
•Anticipated use of Hydroxychloroquine
•Participation in any other clinical trial
•Inability to understand the requirements of the study and to provide informed consent

Study & Design

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