Covid19Phase 2XACTNCT04640181
Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT)
A Phase 2 study testing Enoxaparin and Rivaroxaban in people with Covid19, run by St. David's HealthCare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19
- What is being tested?
- Enoxaparin and Rivaroxaban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 28 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 36Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Enoxaparin, Rivaroxaban
- Keywords
- Coronavirus, Enoxaparin, Rivaroxaban, Anticoagulants, Anti-inflammatory, Anti-viral, ARDS
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Subcutaneous enoxaparin While hospitalized only.
RivaroxabanDrug
Oral rivaroxaban While hospitalized and through discharge for a total of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Dosing: Enoxaparin | Active comparator | * Low 40mg subcutaneous (SQ) daily, or
* Intermediate 40mg SQ q12 hours, or
* Therapeutic 1mg/kg SQ q12 hours Receives: Drug: Enoxaparin |
| Adaptive Dosing: Rivaroxaban | Active comparator | * Low 10mg po daily
* Intermediate 10mg po daily
* Therapeutic 20mg po daily Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or 30-day all cause mortality
Measured: 30 days
Mechanical ventilation, intubation
Measured: 30 days
Transfer to an ICU setting
Measured: 30 days
Secondary outcomes (4)
New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)
Measured: 30 days
New thrombotic events
Measured: 30 days
Major bleeding event
Measured: 30 days
Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Dec 2020
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. David's HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Chafizadeh, MD, Principal investigator, Cardio Texas, PLLCTheresa Pham, MD, Principal investigator, PPD Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640181
- Sponsor's protocol ID
- 2020-001708-41
- Acronym
- XACT
- Status last verified
- Jun 2021
- First submitted
- 19 Nov 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04640181
- Acronym / sponsor ID
- XACT / 2020-001708-41
- Conditions
- Covid19
- Keywords
- Coronavirus, Enoxaparin, Rivaroxaban, Anticoagulants, Anti-inflammatory, Anti-viral, ARDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- St. David's HealthCareUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adaptive Dosing: Enoxaparin | Active comparator | Drug: Enoxaparin* Low 40mg subcutaneous (SQ) daily, or * Intermediate 40mg SQ q12 hours, or * Therapeutic 1mg/kg SQ q12 hours |
| Adaptive Dosing: Rivaroxaban | Active comparator | Drug: Rivaroxaban* Low 10mg po daily * Intermediate 10mg po daily * Therapeutic 20mg po daily |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoxaparinSubcutaneous enoxaparin While hospitalized only. | Drug | Adaptive Dosing: Enoxaparin |
| RivaroxabanOral rivaroxaban While hospitalized and through discharge for a total of 28 days. | Drug | Adaptive Dosing: Rivaroxaban |
Primary outcome
Death or 30-day all cause mortality
Time frame: 30 days
Mechanical ventilation, intubation
Time frame: 30 days
Transfer to an ICU setting
Time frame: 30 days
4 secondary outcomes
New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)
Time frame: 30 days
New thrombotic events
Time frame: 30 days
Major bleeding event
Time frame: 30 days
Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Drug information for Enoxaparin sodium provided by the National Library of MedicineLink provided by the sponsor.
- Xarelto (rivaroxaban) full prescribing informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Chafizadeh, MD principal investigator
Cardio Texas, PLLC
Theresa Pham, MD principal investigator
PPD Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enoxaparin and Rivaroxaban in people with Covid19, run by St. David's HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or 30-day all cause mortality (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.