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

Covid19 Clinical Trial

— XACT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640181
• Other study ID #: 2020-001708-41
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: June 2021
• Source: St. David's HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Enoxaparin
Subcutaneous enoxaparin While hospitalized only.
• Rivaroxaban
Oral rivaroxaban While hospitalized and through discharge for a total of 28 days.

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
St. David's HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or 30-day all cause mortality		30 days
Primary	Mechanical ventilation, intubation		30 days
Primary	Transfer to an ICU setting		30 days
Secondary	New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)		30 days
Secondary	New thrombotic events		30 days
Secondary	Major bleeding event		30 days
Secondary	Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)		30 days

External Links

•   Drug information for Enoxaparin sodium provided by the National Library of Medicine
•   Xarelto (rivaroxaban) full prescribing information