This study is a multicenter, randomized trial to study the potential benefit of treatments with a direct FXa inhibitor (rivaroxaban) versus standard of care dose subcutaneous low molecular weight heparin (LMWH) (Lovenox) in hospitalized subjects with COVID-19.
As clinicians learn how to better care for hospitalized COVID-19 patients, the clinical picture of a hypercoagulable state with abnormal blood clotting has emerged. Fulminant heart, lung, kidney, and liver failure are hallmarks of COVID-19 non-survivors and have been associated with abnormal blood coagulation parameters, such as elevated D-Dimer levels. The current standard of care using prophylactic levels of subcutaneous heparin has not significantly mitigated the risk of patients entering a hypercoagulable state, however the dysregulated thrombotic and inflammatory events that drive poor outcomes in many COVID-19 patients may be amenable to early treatment with a factor Xa (FXa) inhibitor. The purpose of this study is to study the potential benefit of treatments with a direct FXa inhibitor (rivaroxaban) versus standard of care dose subcutaneous LMWH (Lovenox) in hospitalized subjects with COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Subcutaneous enoxaparin While hospitalized only.
Oral rivaroxaban While hospitalized and through discharge for a total of 28 days.
St. David's Medical Center
Austin, Texas, United States
Death or 30-day all cause mortality
Time frame: 30 days
Mechanical ventilation, intubation
Time frame: 30 days
Transfer to an ICU setting
Time frame: 30 days
New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)
Time frame: 30 days
New thrombotic events
Time frame: 30 days
Major bleeding event
Time frame: 30 days
Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)
Time frame: 30 days
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