The purpose of this study is to evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic Coronavirus Disease 2019 (COVID-19) Infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,284
Participants will receive rivaroxaban 10 mg tablet orally once daily.
Participants will receive matching placebo tablet orally once daily.
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
University of Arizona
Tucson, Arizona, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Kaiser Permanente Northern California
Oakland, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Florida Hospital Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Northshore Universite Healthsystem
Evanston, Illinois, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
...and 7 more locations
Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint
Number of participants with time to first occurrence of primary efficacy composite endpoint were reported. Time to first occurrence of primary efficacy composite endpoint is defined as time from randomization to first occurrence of any component of the primary endpoint. The components were: symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, non-central nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality.
Time frame: Up to Day 35
Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
Number of participants with time to first occurrence of the principle safety outcome (fatal bleeding and critical site bleeding) based on a Modification of the ISTH criteria were reported. Fatal bleeding is defined as any bleeding event that leads to fatal outcome. Critical site bleeding defined as any bleeding event that occurred at critical site such as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal.
Time frame: Up to Day 35
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes
Number of participants with time to the first occurrence of secondary efficacy outcomes which included thrombotic events (symptomatic VTE, myocardial infarction, ischemic stroke, acute limb ischemia, non-CNS systemic embolization), emergency room (ER) visit, all-cause mortality, all-cause hospitalization, any thrombotic outcome and all-cause mortality, and any thrombotic outcome and all-cause hospitalization, were reported.
Time frame: From Day 1 up to Day 35
Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria
Number of participants with time to first occurrence of the major bleeding based on a modification of the ISTH criteria were reported. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 grams per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
Time frame: Up to Day 35
Number of Participants Who Were Hospitalized or Dead on Day 35
Number of participants who were hospitalized or dead on Day 35 were reported.
Time frame: At Day 35 (+/- 6 days)
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