A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection
Condition: Coronavirus Disease 2019 (COVID-19)
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Rivaroxaban; Placebo; Standard of Care (SOC)
Intervention description: 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.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1284.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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