CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19 (CONVINCE)
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ClinicalTrials.gov Identifier: NCT04516941 |
Recruitment Status :
Recruiting
First Posted : August 18, 2020
Last Update Posted : June 28, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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SARS-CoV Infection COVID-19 | Drug: Edoxaban Tablets Drug: Colchicine Tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention Model Description: | 2x2 factorial design |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting |
Actual Study Start Date : | January 21, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
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Active Comparator: Edoxaban
Edoxaban 60 mg q.d., or 30 mg q.d. in patients with CrCl = or <50 ml/min or body weight equal or less than 60 kg from randomization to end of study visit at day 25 (+/-3).
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Drug: Edoxaban Tablets
Treatment |
Active Comparator: Colchicine
Colchicine at 0.5 mg per os (PO) twice daily for the first 3 days and then once daily from randomization to day 14 (+/-3) days. Treatment could be continued to day 25 (+3/-3 days).
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Drug: Colchicine Tablets
Treatment |
No Intervention: No Edoxaban and No Colchicine
No intervention
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Active Comparator: Edoxaban and Colchicine
Edoxaban 60 mg q.d., or 30 mg q.d. in patients with CrCl = or <50 ml/min or body weight equal or less than 60 kg from randomization to end of study visit at day 25 (+/-3). Colchicine at 0.5 mg per os (PO) twice daily for the first 3 days and then once daily from randomization to day 14 (+/-3) days. Treatment could be continued to day 25 (+3/-3 days). |
Drug: Edoxaban Tablets
Treatment Drug: Colchicine Tablets Treatment |
- Edoxaban vs. no active treatment [ Time Frame: Baseline to day 25 ]To assess the effect of edoxaban versus no active treatment on the composite endpoint 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 or death at day 25 (+/-3) after randomization.
- Colchicine vs no active treatment [ Time Frame: Baseline to day 14 ]To assess the effect of colchicine versus no active treatment on the SARS-CoV-2 clearance rates under RT PCR or freedom from death or hospitalisation at day 14 (+/-3) after randomization.
- Number of patients with asymptomatic proximal deep-vein thrombosis [ Time Frame: Baseline to day 25 ]An intraluminal filling defect on CT scan or MR venography in the IVC or iliac veins.
- Number of patients with symptomatic proximal or distal deep-vein thrombosis [ Time Frame: Baseline to day 25 ]Typical symptoms of DVT associated with non-compressible vein segment on ultrasonography or an intra-luminal filling defect on venography, CT venography or MRI venography,located in the inferior vena cava (IVC), the iliac vein, the common femoral vein, the femoral or the popliteal vein.
- Number of patient with symptomatic pulmonary embolism or thrombosis [ Time Frame: Baseline to day 25 ]
Typical symptoms of PE associated with
- an intra-luminal filling defect in (sub) segmental or more proximal branches on spiral computed tomography scan (CT) or computerized tomographic pulmonary angiography (CTPA).
- a considerable perfusion defect (~ 75% of a segment) with a local normal ventilation result (high probability) during perfusion-ventilation lung scan (PLS, VLS or V/Q scan).
- an intraluminal filling defect or a sudden cut-off of vessels (~more than 2.5 mm in diameter) on a catheter guided pulmonary angiogram.
In case of an inconclusive CTPA, inconclusive V/Q scan or inconclusive angiography demonstration of DVT in the lower extremities e.g. by compression ultrasound or venography will be required
- Number of patients with myocardial infarction [ Time Frame: Baseline to day 25 ]For the primary analysis, MI endpoint will be defined based on the third universal definition of myocardial infarction with the exception of periprocedural MI after PCI, which will be defined according to the SCAI definition.
- Number of patients with ischemic stroke [ Time Frame: Baseline to day 25 ]
- Number of patients with non-CNS systemic embolism [ Time Frame: Baseline to day 25 ]Ischemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by CNS infarction
- Number of deaths [ Time Frame: Baseline to day 25 ]Death will be classified in 5 categories with respect to cause. Thromboembolism, cardiovascular, bleeding, Pulmonary other known cause. In general, all deaths will be assumed to be due to thromboembolism or pulmonary in nature unless another cause is obvious
- Ventilation need [ Time Frame: Baseline to day 25 ]Need for non-invasive or invasive ventilation

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516941
Contact: Stephan Windecker, Prof. Dr. | +41 31 63 2 44 97 | Stephan.Windecker@insel.ch |
Belgium | |
Jessa Ziekenhuis | Recruiting |
Hasselt, Belgium, 3500 | |
Contact: Pascal Vrancks, MD pascal.vranckx@jessazh.be | |
Italy | |
Azienda ULSS n.4 "Veneto Orientale" | Withdrawn |
Jesolo, Veneto, Italy, 30016 | |
ASST Papa Giovanni XXIII | Withdrawn |
Bergamo, Italy, 24127 | |
ASST Rhodense | Recruiting |
Garbagnate Milanese, Italy, 20024 | |
Contact: Barbara Omazzi, MD bomazzi@asst-rhodense.it | |
Azienda Socio Sanitaria Territoriale di Lecco | Withdrawn |
Lecco, Italy, 23900 | |
ASST Grande Ospedal Metropolitano Niguardia | Recruiting |
Milan, Italy, 3 | |
Contact: Luca Bonacchini, MD luca.bonacchini@ospedaleniguardia.it | |
IRCCS Policlinico San Matteo | Recruiting |
Pavia, Italy, 27100 | |
Contact: Sergio Leonardi, MD s.leonardi@smatteo.pv.it | |
Azienda Unita' Sanitaria Locale della Romagna | Withdrawn |
Ravenna, Italy, 47923 | |
Spain | |
Hospital Clinic de Barcelona | Withdrawn |
Barcelona, Spain, 08036 | |
Switzerland | |
Ospedale regionale Lugano | Recruiting |
Lugano, Ticino, Switzerland, 6900 | |
Contact: Marco Valgimigli, MD +41 91805 31 15 marco.valgimigli@eoc.ch | |
Bern University Hospital | Not yet recruiting |
Bern, Switzerland, 3010 | |
Contact: Stephan Windecker, MD +41316324497 ext +41316324497 Stephan.Windecker@insel.ch | |
Contact: Stephan Windecker +41316324497 ext +41316324497 Stephan.Windecker@insel.ch |
Study Chair: | Stephan Windecker, Prof. Dr. | Bern University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT04516941 |
Other Study ID Numbers: |
CONVINCE Version 1.0 12052020 |
First Posted: | August 18, 2020 Key Record Dates |
Last Update Posted: | June 28, 2022 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections COVID-19 Severe Acute Respiratory Syndrome Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Colchicine |
Edoxaban Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Anticoagulants |