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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)

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ClinicalTrials.gov Identifier: NCT04508023
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Drug: Rivaroxaban Other: Placebo Other: Standard of Care (SOC) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19 Infection
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : February 22, 2022
Estimated Study Completion Date : February 22, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Rivaroxaban
Participants will receive rivaroxaban 10 milligram (mg) tablet orally once daily for 35 Days along with standard of care treatment (SOC).
Drug: Rivaroxaban
Participants will receive rivaroxaban 10 mg tablet orally once daily.
Other Names:
  • JNJ-39039039
  • BAY 59-7939

Other: Standard of Care (SOC)
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.

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




Primary Outcome Measures :
  1. Time to First Occurrence of a Composite Endpoint of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, All-cause Hospitalization and All-cause Mortality [ Time Frame: Up to Day 35 ]
    Time to first occurrence of a composite endpoint of symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, noncentral nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality will be assessed.


Secondary Outcome Measures :
  1. Time to First Occurrence of a Composite Endpoint of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, and All-cause Mortality [ Time Frame: Up to Day 35 ]
    Time to first occurrence of a composite endpoint of symptomatic VTE, MI, ischemic stroke, acute limb ischemia, non-CNS systemic embolization, and all-cause mortality will be assessed.

  2. Time to First Occurrence of All-cause Hospitalization [ Time Frame: Up to Day 35 ]
    Time to first occurrence of all-cause hospitalization will be assessed.

  3. Time to First Occurrence of Symptomatic VTE [ Time Frame: Up to Day 35 ]
    Time to first occurrence of symptomatic VTE which includes DVT or pulmonary embolism (PE) will be assessed.

  4. Time to First Occurrence of an Emergency Room (ER) Visit [ Time Frame: Up to Day 35 ]
    Time to first occurrence of an ER visit will be assessed.

  5. Time to First Occurrence of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, and All-cause Hospitalization [ Time Frame: Up to Day 35 ]
    Time to first occurrence of symptomatic VTE, MI, ischemic stroke, acute limb ischemia, non-CNS systemic embolization, and all-cause hospitalization will be assessed.

  6. Percentage of Participants who are Hospitalized or Dead From Any Cause [ Time Frame: Day 35 ]
    Percentage of participants who are hospitalized or dead from any cause at Day 35 will be assessed.

  7. Time to All-cause Mortality up to Day 35 [ Time Frame: Up to Day 35 ]
    Time to all-cause mortality up to Day 35 will be assessed.

  8. Time to First Occurrence of International Society on Thrombosis and Hemostasis (ISTH) Critical Site and Fatal Bleeding [ Time Frame: Up to 37 Days (last dose on Day 35 plus 2 Days) ]
    Time to first occurrence of ISTH critical site and fatal bleeding will be assessed.

  9. Time to First Occurrence of ISTH Major Bleeding Events [ Time Frame: Up to 37 Days (last dose on Day 35 plus 2 Days) ]
    Time to first occurrence of ISTH major bleeding will be assessed. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram 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.

  10. Time to First Occurrence of Clinically Relevant Non-major Bleeding [ Time Frame: Up to 37 Days (last dose on Day 35 plus 2 Days) ]
    Time to first occurrence of clinically relevant non-major bleeding will be assessed. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508023


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04508023    
Other Study ID Numbers: CR108849
39039039DVT3004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants