Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
60 participants
INTERVENTIONAL
2021-01-21
2022-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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).
Edoxaban Tablets
Treatment
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).
Colchicine Tablets
Treatment
No Edoxaban and No Colchicine
No intervention
No interventions assigned to this group
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).
Edoxaban Tablets
Treatment
Colchicine Tablets
Treatment
Interventions
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Edoxaban Tablets
Treatment
Colchicine Tablets
Treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
INDUSTRY
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Stephan Windecker, Prof. Dr.
Role: STUDY_CHAIR
Bern University Hospital
Locations
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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
Countries
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References
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Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
Zhou F, Fan G, Liu Z, Cao B. SARS-CoV-2 shedding and infectivity - Authors' reply. Lancet. 2020 Apr 25;395(10233):1340. doi: 10.1016/S0140-6736(20)30869-2. Epub 2020 Apr 15. No abstract available.
Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.
Ranucci M, Ballotta A, Di Dedda U, Baryshnikova E, Dei Poli M, Resta M, Falco M, Albano G, Menicanti L. The procoagulant pattern of patients with COVID-19 acute respiratory distress syndrome. J Thromb Haemost. 2020 Jul;18(7):1747-1751. doi: 10.1111/jth.14854. Epub 2020 May 6.
Panigada M, Bottino N, Tagliabue P, Grasselli G, Novembrino C, Chantarangkul V, Pesenti A, Peyvandi F, Tripodi A. Hypercoagulability of COVID-19 patients in intensive care unit: A report of thromboelastography findings and other parameters of hemostasis. J Thromb Haemost. 2020 Jul;18(7):1738-1742. doi: 10.1111/jth.14850. Epub 2020 Jun 24.
Poissy J, Goutay J, Caplan M, Parmentier E, Duburcq T, Lassalle F, Jeanpierre E, Rauch A, Labreuche J, Susen S; Lille ICU Haemostasis COVID-19 Group. Pulmonary Embolism in Patients With COVID-19: Awareness of an Increased Prevalence. Circulation. 2020 Jul 14;142(2):184-186. doi: 10.1161/CIRCULATIONAHA.120.047430. Epub 2020 Apr 24. No abstract available.
Landi A, Morici N, Vranckx P, Frigoli E, Bonacchini L, Omazzi B, Tresoldi M, Camponovo C, Moccetti T, Valgimigli M. Edoxaban and/or colchicine in outpatients with COVID-19: rationale and design of the CONVINCE trial. J Cardiovasc Med (Hagerstown). 2023 Dec 1;24(12):920-930. doi: 10.2459/JCM.0000000000001556. Epub 2023 Nov 3.
Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
Other Identifiers
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CONVINCE Version 1.0 12052020
Identifier Type: -
Identifier Source: org_study_id
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