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
NCT ID: NCT04508023
Last Updated: 2023-07-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1284 participants
INTERVENTIONAL
2020-08-13
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rivaroxaban
Participants will receive rivaroxaban 10 milligram (mg) tablet orally once daily for 35 Days along with standard of care treatment (SOC).
Rivaroxaban
Participants will receive rivaroxaban 10 mg tablet orally once daily.
Standard of Care (SOC)
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
Placebo
Participants will receive matching placebo tablet orally once daily for 35 Days along with SOC.
Placebo
Participants will receive matching placebo tablet orally once daily.
Standard of Care (SOC)
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
Interventions
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Rivaroxaban
Participants will receive rivaroxaban 10 mg tablet orally once daily.
Placebo
Participants will receive matching placebo tablet orally once daily.
Standard of Care (SOC)
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Countries
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References
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Piazza G, Spyropoulos AC, Hsia J, Goldin M, Towner WJ, Go AS, Bull TM, Weng S, Lipardi C, Barnathan ES, Bonaca MP; PREVENT-HD Investigators. Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial. Circulation. 2023 Jun 20;147(25):1891-1901. doi: 10.1161/CIRCULATIONAHA.123.063901. Epub 2023 May 8.
Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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39039039DVT3004
Identifier Type: OTHER
Identifier Source: secondary_id
CR108849
Identifier Type: -
Identifier Source: org_study_id
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