Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT)

• Status: Completed
• Trial end date: 2021-06-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. David's HealthCare
• Treatments: Enoxaparin; Rivaroxaban

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

• Allergy to heparin or rivaroxaban or any factor Xa inhibitors, including a history of heparin-induced thrombocytopenia

• History of antiphospholipid syndrome

• End-stage renal failure requiring dialysis

• Valvular heart disease requiring chronic anticoagulation

• History of atrial fibrillation, atrial flutter or venous thromboembolic event (VTE) currently requiring anticoagulation

• History of solid organ transplant requiring immunosuppressant therapy

• Cancer requiring ongoing anticoagulation

• History of cirrhosis or liver failure, hepatorenal syndrome

• History of baseline bronchiectasis

• History of systemic lupus erythematosus or other autoimmune diseases requiring immunosuppressant therapy.

Vital signs

• Uncontrolled hypertension: systolic blood pressure (SBP) > 180 mm Hg or diastolic blood pressure (DBP) > 105mm Hg. Subjects who have a transient, higher blood pressure elevation (SBP 180-200 mm Hg) may enter the study if a repeat confirmation is back in range prior to enrollment.

Laboratory

• PT INR > 2.0.

• Platelet < 90 10^3/µL

• Total bilirubin > 3.0 mg/dL

• Hemoglobin < 9.0 g/dL

• Urine with gross hematuria (not due to menses)

• Estimated glomerular filtration rate (GFR) less than 30 mL/min calculated with the Cockcroft-Gault formula

Medications

• Patients on dual anti-platelet therapy

• Patients taking hypoxia-inducible factor prolyl hydroxylase inhibitors (such as roxadustat.)

• Erythropoiesis-stimulating agents (such as epoetin alfa, darbepoetin alfa)

Other COVID-19 drug studies or trials

• Any COVID19 vaccination trials

• Experimental COVID drug trial except for treatment(s) that has become accepted standard of care.