E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients ≥ 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.
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E.1.1.1 | Medical condition in easily understood language |
Patients ≥ 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection who are managed at home or in another out-of-hospital setting. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients ≥ 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting. |
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E.4 | Principal 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 hemorrhage, known or suspected esophageal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
This study has 2 co-primary endpoints, one each randomization as follows:
Edoxaban vs. no active treatment Major vascular thrombotic events (MVTE) at 25 (+/-3) days defined as a composite 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 •Death
Colchicine vs no active treatment The SARS-CoV-2 detection rates at day 14 (+/-3) under RT PCR or freedom from death or hospitalisation
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
14 (+/-3) and 25 (+/-3) days |
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E.5.2 | Secondary end point(s) |
The secondary endpoints of the study are the following: 1)Each component of the co-primary endpoints 2)Need for non-invasive or invasive ventilation 3)Any combination of the above endpoints 4)Impact of either intervention on coagulation and inflammatory biomarkers including IL-6, CRP, D-dimers, sCD40L, Fibrinogen, Factor X activity. 5)EKG analyses for QT segment measures and for detection of EKC changes associated to myo-pericarditis. 6)HsTroponin levels 7)Bleeding endpoints according to the Bleeding Academic Research Consortium (BARC) 2, 3 or 5 and ISTH major and clinically relevant non-major bleeding
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
14 (+/-3) and 25 (+/-3) days |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |