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

Completed · Phase 2

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04640181

Run by

St. David's HealthCare

People needed

150

Starts

2020-12-01

Expected to finish

2021-06-28

Last updated by the study team

2021-06-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• St. David's Medical Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.