Status:
TERMINATED
CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
SARS-CoV Infection
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.
Exclusion
- 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
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04516941
Start Date
January 21 2021
End Date
August 31 2022
Last Update
September 8 2022
Active Locations (5)
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1
Jessa Ziekenhuis
Hasselt, Belgium, 3500
2
ASST Rhodense
Garbagnate Milanese, Italy, 20024
3
ASST Grande Ospedal Metropolitano Niguardia
Milan, Italy, 3
4
Ospedale regionale Lugano
Lugano, Canton Ticino, Switzerland, 6900