A Phase 2-3, Multi-Center, Randomized Trial to Study the Potential Benefit of Factor Xa Inhibitor (Rivaroxaban) Versus Standard of Care Low Molecular Weight Heparin (Lovenox) in Hospitalized Patients With COVID-19 (XACT)
Overview
- Phase
- Phase 2
- Intervention
- Enoxaparin
- Conditions
- Covid19
- Sponsor
- St. David's HealthCare
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Death or 30-day all cause mortality
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients age 18-100 admitted to hospital with laboratory-confirmed SARS-CoV-2 infection
- •Not be intubated or mechanically ventilated or imminently at risk for same or ICU admission within 24 hours of enrollment.
- •Not be admitted for central nervous system (CNS) diagnosis
- •Not have a current history of a condition requiring full therapeutic anticoagulation such as venous thromboembolism, atrial fibrillation.
Exclusion Criteria
- •Medical Conditions
- •Life expectancy of less than 6 months
- •Active or recent gastrointestinal bleeding in the past 6 months
- •Intracranial bleeding in the past 6 months
- •Major trauma or head trauma in the past 2 months
- •Major surgery in the past 2 months or planned within 2 weeks after completion of the study
- •Recent spinal or epidural procedures in the past 2 weeks
- •Ischemic stroke in the past 2 weeks
- •History of intracranial neoplasm, arteriovenous malformation or aneurysm
- •History of acquired or spontaneous impairment of hemostasis such as but not limited to hemophilia, idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), von Willebrand disease
Arms & Interventions
Adaptive Dosing: Enoxaparin
* Low 40mg subcutaneous (SQ) daily, or * Intermediate 40mg SQ q12 hours, or * Therapeutic 1mg/kg SQ q12 hours
Intervention: Enoxaparin
Adaptive Dosing: Rivaroxaban
* Low 10mg po daily * Intermediate 10mg po daily * Therapeutic 20mg po daily
Intervention: Rivaroxaban
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Major bleeding event(30 days)
- Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)(30 days)
- New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)(30 days)
- New thrombotic events(30 days)