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 (PREVENT-HD)

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 3

Conditions: Coronavirus Disease 2019 (COVID-19)

Treatments: Other: Standard of Care (SOC); Other: Placebo; Drug: Rivaroxaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT04508023

CR108849

39039039DVT3004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,284 participants in 2 patient groups, including a placebo group

Rivaroxaban

Experimental group

Description:

Participants will receive rivaroxaban 10 milligram (mg) tablet orally once daily for 35 Days along with standard of care treatment (SOC).

Treatment:

Drug: Rivaroxaban

Other: Standard of Care (SOC)

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo tablet orally once daily for 35 Days along with SOC.

Treatment:

Other: Placebo

Other: Standard of Care (SOC)