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

NCT04640181 | Completed Phase 2 FDA Drug

• 1 other identifier: 2020-001708-41
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Coronavirus; Enoxaparin; Rivaroxaban; Anticoagulants; Anti-inflammatory; Anti-viral; ARDS

Outcome Measures

Primary Outcomes (3)

• Death or 30-day all cause mortality

  30 days

• Mechanical ventilation, intubation

  30 days

• Transfer to an ICU setting

  30 days

Secondary Outcomes (4)

• New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)

  30 days

• New thrombotic events

  30 days

• 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

Study Arms (2)

Adaptive Dosing: Enoxaparin

ACTIVE COMPARATOR

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

Drug: Enoxaparin

Adaptive Dosing: Rivaroxaban

ACTIVE COMPARATOR

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

Drug: Rivaroxaban

Interventions

Enoxaparin DRUG

Subcutaneous enoxaparin While hospitalized only.

Adaptive Dosing: Enoxaparin

Rivaroxaban DRUG

Oral rivaroxaban While hospitalized and through discharge for a total of 28 days.

Adaptive Dosing: Rivaroxaban

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• St. David's HealthCare: lead

Study Sites (1)

St. David's Medical Center

Austin, Texas, 78705, United States

Location

Related Links

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

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Enoxaparin; Rivaroxaban

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Edward Chafizadeh, MD

  Cardio Texas, PLLC

  PRINCIPAL INVESTIGATOR

• Theresa Pham, MD

  PPD Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 23, 2020
• Study Start: December 1, 2020
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

US (1)