Loading clinical trials...
Loading clinical trials...
Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Jessa Ziekenhuis
Hasselt, Belgium
ASST Rhodense
Garbagnate Milanese, Italy
ASST Grande Ospedal Metropolitano Niguardia
Milan, Italy
Ospedale regionale Lugano
Lugano, Canton Ticino, Switzerland
Bern University Hospital
Bern, Switzerland
Start Date
January 21, 2021
Primary Completion Date
August 31, 2022
Completion Date
August 31, 2022
Last Updated
September 8, 2022
60
ACTUAL participants
Edoxaban Tablets
DRUG
Colchicine Tablets
DRUG
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287