COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04640181

Theresa Pham, MD

theresa.pham@ppdi.com

2020-11-23

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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.

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.

2

St. David's HealthCare

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

150

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

None

Phase 2

[{"arm_notes": "", "treatment_id": 465, "treatment_name": "Enoxaparin sodium", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1124, "treatment_name": "Rivaroxaban", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]