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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Rivaroxaban
Sponsored by
St. David's HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Coronavirus, Enoxaparin, Rivaroxaban, Anticoagulants, Anti-inflammatory, Anti-viral, ARDS

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. David's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Adaptive Dosing: Enoxaparin

Adaptive Dosing: Rivaroxaban

Arm Description

Low 40mg subcutaneous (SQ) daily, or Intermediate 40mg SQ q12 hours, or Therapeutic 1mg/kg SQ q12 hours

Low 10mg po daily Intermediate 10mg po daily Therapeutic 20mg po daily

Outcomes

Primary Outcome Measures

Death or 30-day all cause mortality
Mechanical ventilation, intubation
Transfer to an ICU setting

Secondary Outcome Measures

New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)
New thrombotic events
Major bleeding event
Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)

Full Information

First Posted
November 19, 2020
Last Updated
June 28, 2021
Sponsor
St. David's HealthCare
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1. Study Identification

Unique Protocol Identification Number
NCT04640181
Brief Title
Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. David's HealthCare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Coronavirus, Enoxaparin, Rivaroxaban, Anticoagulants, Anti-inflammatory, Anti-viral, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open-label Multicenter Prospective Randomized Trial in hospitalized patients with severe acute respiratory syndrome (SARS)-CoV-2 infection. Patients will be randomized 1:1 to subcutaneous enoxaparin (Lovenox) versus rivaroxaban after hospitalization, with the exact dosing is based on an adaptive strategy.
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Dosing: Enoxaparin
Arm Type
Active Comparator
Arm Description
Low 40mg subcutaneous (SQ) daily, or Intermediate 40mg SQ q12 hours, or Therapeutic 1mg/kg SQ q12 hours
Arm Title
Adaptive Dosing: Rivaroxaban
Arm Type
Active Comparator
Arm Description
Low 10mg po daily Intermediate 10mg po daily Therapeutic 20mg po daily
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Subcutaneous enoxaparin While hospitalized only.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
Oral rivaroxaban While hospitalized and through discharge for a total of 28 days.
Primary Outcome Measure Information:
Title
Death or 30-day all cause mortality
Time Frame
30 days
Title
Mechanical ventilation, intubation
Time Frame
30 days
Title
Transfer to an ICU setting
Time Frame
30 days
Secondary Outcome Measure Information:
Title
New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)
Time Frame
30 days
Title
New thrombotic events
Time Frame
30 days
Title
Major bleeding event
Time Frame
30 days
Title
Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Chafizadeh, MD
Organizational Affiliation
Cardio Texas, PLLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theresa Pham, MD
Organizational Affiliation
PPD Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://druginfo.nlm.nih.gov/drugportal/name/Enoxaparin+sodium
Description
Drug information for Enoxaparin sodium provided by the National Library of Medicine
URL
http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf
Description
Xarelto (rivaroxaban) full prescribing information

Learn more about this trial

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

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