Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting. MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Lixiana 30mg
Product Name: Edoxaban
Product Code: [Edoxaban]
Pharmaceutical Form: Film-coated tablet
CAS Number: 912273-65-5
Current Sponsor code: Edoxaban
Concentration unit: mg milligram
Sponsors
INSEL GRUPPE AG, BERN UNIVERSITY HOSPITAL, DEPARTMENT OF CARDIOLOGY
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 haemorrhage, known or suspected oesophageal 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR;Secondary Objective: N.A.;Primary end point(s): This study has 2 co-primary endpoints, one each randomization as follows: Edoxaban vs. no active treatment Major vascular thrombotic events (MVTE) at 25 (+/-3) days defined as a composite of: • Asymptomatic proximal deep-vein thrombosis • Symptomatic proximal or distal deep-vein thrombosis • Symptomatic pulmonary embolism or thrombosis • Myocardial infarction • Ischemic stroke • non-CNS systemic embolism • Death Colchicine vs no active treatment The SARS-CoV-2 detection rates at day 14 (+/-3) under RT PCR or freedom from death or hospitalisation;Timepoint(s) of evaluation of this end point: 14 (+/-3) and 25 (+/-3) days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the study are the following: 1) Each component of the co-primary endpoints 2) Need for non-invasive or invasive ventilation 3) Need for oxygen therapy 4) Body temperature kinetics 5) Need for analgesics including NSAIDs and/or paracetamol 6) Need for hospitalisation and total days in the hospital 7) Any combination of the above endpoints 8) Each component of the primary endpoint as well as pre-specified composite endpoints at the time all SAEs have come to a resolution 9) Impact of either intervention on coagulation and inflammatory biomarkers including IL-6, CRP, D-dimers, sCD40L, Fibrinogen, Factor X activity and Factor XIa 10) EKG analyses for QT segment measures and for detection of EKC changes associated to myopericarditis. 11) HsTroponin levels 12) Bleeding endpoints according to the Bleeding Academic Research Consortium (BARC) 2, 3 or 5 and ISTH major and clinically relevant non-major bleeding | — |
Countries
Belgium, Italy, Spain, Switzerland
Contacts
Public ContactCardiologia
Insel Gruppe AG, Bern University Hospital Department of Cardiology
Outcome results
None listed