Official Title
Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting
Brief Summary

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.

Terminated
SARS-CoV Infection
COVID-19

Drug: Edoxaban Tablets

Treatment

Drug: Colchicine Tablets

Treatment

Eligibility Criteria

Inclusion Criteria:

Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at
home or in another out-of-hospital setting.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Belgium
Italy
Switzerland
Locations

Jessa Ziekenhuis
Hasselt, Belgium

ASST Rhodense
Garbagnate Milanese, Italy

ASST Grande Ospedal Metropolitano Niguardia
Milan, Italy

Ospedale regionale Lugano
Lugano, Ticino, Switzerland

Bern University Hospital
Bern, Switzerland

Stephan Windecker, Prof. Dr., Study Chair
Bern University Hospital

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
NCT Number
MeSH Terms
Infections
COVID-19
Severe Acute Respiratory Syndrome
Colchicine
Edoxaban