factor xa inhibitor versus standard of care heparin in hospitalized patients with covid-19 (xact)

Conditions: Covid19

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.

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.

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.

Keywords: coronavirus enoxaparin rivaroxaban anticoagulants anti-inflammatory anti-viral ards