NCT04640181.

Study name	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)
Starting date	1 December 2020
Contact information	Matt Cowperthwaite, PhD St. David's Medical Center Austin, Texas, USA, 78705 512‐544‐2626 | info@stdavidsresearch.com
Methods	Prospective, multicentre, open‐label, 1:1, parallel‐assignment RCT
Participants	150 participants, ≥ 18 years, female and male Inclusion criteria: Patients aged 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 h of enrolment Not be admitted for CNS diagnosis Not have a current history of a condition requiring full therapeutic anticoagulation such as VTE, atrial fibrillation. Exclusion criteria: Medical conditions Life expectancy of < 6 months Active or recent GI 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 Ischaemic stroke in the past 2 weeks History of intracranial neoplasm, arteriovenous malformation or aneurysm History of acquired or spontaneous impairment of haemostasis such as but not limited to haemophilia, 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 HIT History of antiphospholipid syndrome End‐stage renal failure requiring dialysis Valvular heart disease requiring chronic anticoagulation History of atrial fibrillation, atrial flutter or 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: SBP > 180 mm Hg or DBP > 105 mmHg. Participants who have a transient, higher blood pressure elevation (SBP 180‐200 mmHg) may enter the study if a repeat confirmation is back in range prior to enrolment Laboratory PT INR > 2.0 Platelet < 90 10^3/µL Total bilirubin > 3.0 mg/dL Haemoglobin < 9.0 g/dL Urine with gross haematuria (not due to menses) Estimated GFR < 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 COVID‐19 vaccination trials Experimental COVID drug trial except for treatment(s) that has become accepted standard care
Interventions	Experimental: adaptive dosing: rivaroxaban Low 10 mg oral daily Intermediate 10 mg oral daily therapeutic 20 mg oral daily Comparator: adaptive dosing: enoxaparin Low 40 mg SC daily, or Intermediate 40 mg SC every 12 h, or Therapeutic 1 mg/kg SC every 12 h
Outcomes	Primary 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) Secondary New requirement for haemodialysis or continuous renal replacement therapy or 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 hospitalised but require no oxygen) (time frame: 30 days)
Notes	NCT04640181 | No data provided