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.
Drug: Rivaroxaban
Participants will receive rivaroxaban 10 mg tablet orally once daily.
Other Name: Array
Other: Placebo
Participants will receive matching placebo tablet orally once daily.
Other: Standard of Care (SOC)
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
Inclusion Criteria:
- Coronavirus Disease 2019 (COVID-19) positive diagnosis by locally obtained viral
diagnostic test (example, polymerase chain reaction [PCR]). This may be nasal swab or
saliva test or other available technology to demonstrate current infection
- Confirm that participant is known to health system, with at least 1 contact in
electronic medical records (EMR) prior to screening
- Symptoms attributable to COVID-19 (example, fever, cough, loss of taste or smell,
muscle aches, shortness of breath, fatigue)
- Initial treatment plan does not include hospitalization
- Presence of at least 1 additional risk factor: a) age more than or equal to (>=) 60
years; b) prior history of VTE; c) history of thrombophilia; d) history of coronary
artery disease (CAD); e) history of peripheral artery disease (PAD); f) history of
cerebrovascular disease or ischemic stroke; g) history of cancer (other than basal
cell carcinoma) h) history of diabetes requiring medication; i) history of heart
failure; j) body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter
square (kg/m^2); k) D-dimer greater than (>) upper limit of normal for local
laboratory (within 2 weeks of the date of the COVID-19 test and prior to
randomization)
Exclusion Criteria:
- Increased risk of bleeding such as a) significant bleeding in the last 3 months; b)
active gastroduodenal ulcer in the last 3 months; c) history of bronchiectasis or
pulmonary cavitation; d) need for dual antiplatelet therapy or anticoagulation; e)
prior intracranial hemorrhage, f) known severe thrombocytopenia g) active cancer and
undergoing treatment
- Any illness or condition that in the opinion of the investigator would significantly
increase the risk of bleeding (example recent trauma, recent surgery, severe
uncontrolled hypertension, gastrointestinal cancer, renal failure requiring dialysis,
severe liver disease, known bleeding diathesis)
- Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
- Positive COVID-19 antibody or serology test after 2-week period of acute, symptomatic
COVID-19 infection
- Known diagnosis of triple positive (positive for lupus anticoagulant, anticardiolipin,
and anti-beta 2-glycoprotein I antibodies) antiphospholipid syndrome
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
Brigham & Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Lenox Hill Hospital -Northwell Health
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Health Physicians Group
Fort Worth, Texas, United States
Franciscan Research Center
Tacoma, Washington, United States
Janssen Research & Development, LLC Clinical Trial, Study Director
Janssen Research & Development, LLC