There is emerging evidence that patients with SARS-CoV-2 are affected by increased
coagulopathy, including in the most advanced forms, a fully blown disseminated intravascular
coagulation, leading to multi organ failure (MOF). Post-Morten observations from patients who
died because of SARS-CoV-2 infection in Bergamo, Italy and other places have revealed the
presence of diffuse venous, arterial and microcirculatorythrombosis, not only restricted to
the lung but also involving the kidneys, heart and gut.
Thrombin plays a central role in mediating clot forming as well as in mediating inflammation.
A direct factor X inhibitor, namely edoxaban can act as prophylactic measure to mitigate the
risk of venous and arterial thrombotic complications.
Colchicine is an inexpensive (generic drug), orally administered, and a potent
anti-inflammatory medication. It might accelerate SARS-CoV-2 clearance.
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Collaborator:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company