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About
Patients with moderate to severe COVID-19 present a very high risk of thromboembolic disease.This multicenter, prospective, randomized, event-driven study evaluates rivaroxaban compared with standard of care with low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) at prophylactic doses comparing D-dimer levels and the seven-category ordinal scale recommended by the WHO 7 days post randomization in patients with moderate to severe COVID-19.
Experimental intervention/Index test:
Patients randomized into the rivaroxaban arm will receive rivaroxaban 20 mg once daily (OD) until day 7 post randomization or hospital discharge, whichever occurs later, followed by a 28-day-phase of prophylactic anticoagulation with rivaroxaban 10mg OD. Subjects with an eGFR between 30 and 50ml/min/1,73m2, will receive 15mg instead of 20mg OD.
Control intervention/Reference test:
The control group will receive standard of care including LMWH or UFH as thromboprophylaxis.
Duration of intervention per patient:
The total duration of the study treatment is flexible. For out-patients 7 days of therapeutic anticoagulation will be accompanied by 28 days-phase of prophylactic anticoagulation, summing up to 35 days. For subjects that require hospitalization, the duration of therapeutic anticoagulation will be at least 7 days or prolonged until discharge if hospitalized for more than 7 days post randomization.
After discharge from the hospital the subject receives 28 days of thromboprophylaxis with rivaroxaban. No study medication will be given past day 60 post randomization. This adds up to a study duration between 35 and 60 days depending on the duration of the hospital stay.
Follow-up per patient:
The study has a follow-up of 60 days.
Experimental and/or control off label or on label in Germany:
Rivaroxaban has been approved for multiple indications worldwide. Over 100,000 subjects have been studied from Phase 1 through multiple large Phase 4 studies in multiple settings, e.g. for the reduction in the risk of stroke and systemic embolism in arterial fibrillation, deep vein thrombosis and pulmonary embolism, major cardiovascular events. The drug had not been studied in patients with COVID-19 as an anticoagulant agent, yet.
Enrollment
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Inclusion criteria
Subject must be willing, understanding and able to provide written informed consent
Subject must be a man or a woman with age > 18 years at screening
Subject must have an active moderate to severe COVID-19 confirmed by
o A positive SARS-CoV-2 PCR test in the last 14 days
At least one of the following features should be present
D-Dimer elevation > 1.5 ULN (age adjusted cut-offs) AND/OR
Cardiac injury reflected by an elevation in hs-cTnT > 2.0 upper limit of normal (ULN) AND at least one of the following conditions:
A woman of childbearing potential must have a negative serum or urine pregnancy test before randomization occurs. Before randomization, a woman must be either:
Postmenopausal, defined as >45 years of age with amenorrhea for at least 18 months,
If menstruating:
Exclusion criteria
Subject has a very high bleeding risk: Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:
Subject has any of the following diseases in the medical history:
Subject has undergone any of the following procedures or received any of the following drugs:
Subject is a woman who is pregnant or breast-feeding.
Known intolerance or history of hypersensitivity to the active substance or to any of the excipients of the Investigational Medicinal Product (IMP)
Subjects who are legally detained in an official institution.
Subjects who may be dependent on the sponsor, the investigator or the trial sites, are not eligible to enter the trial.
Primary purpose
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111 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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