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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 : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE August 10, 2020
First Posted Date  ICMJE August 11, 2020
Last Update Posted Date January 5, 2022
Actual Study Start Date  ICMJE August 13, 2020
Estimated Primary Completion Date February 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Disease 2019 (COVID-19)
Intervention  ICMJE
  • Drug: Rivaroxaban
    Participants will receive rivaroxaban 10 mg tablet orally once daily.
    Other Names:
    • JNJ-39039039
    • BAY 59-7939
  • 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.
Study Arms  ICMJE
  • Experimental: Rivaroxaban
    Participants will receive rivaroxaban 10 milligram (mg) tablet orally once daily for 35 Days along with standard of care treatment (SOC).
    Interventions:
    • Drug: Rivaroxaban
    • Other: Standard of Care (SOC)
  • Placebo Comparator: Placebo
    Participants will receive matching placebo tablet orally once daily for 35 Days along with SOC.
    Interventions:
    • Other: Placebo
    • Other: Standard of Care (SOC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 22, 2022
Estimated Primary Completion Date February 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04508023
Other Study ID Numbers  ICMJE CR108849
39039039DVT3004 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP