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

NCT04508023 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: CR10884939039039DVT3004
• Study Type: interventional
• Target: 1,284
• Locations: 1 country
• Sites: 17

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.

Conditions

Coronavirus Disease 2019 (COVID-19)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint

  Number of participants with time to first occurrence of primary efficacy composite endpoint were reported. Time to first occurrence of primary efficacy composite endpoint is defined as time from randomization to first occurrence of any component of the primary endpoint. The components were: symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, non-central nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality.

  Up to Day 35

• Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria

  Number of participants with time to first occurrence of the principle safety outcome (fatal bleeding and critical site bleeding) based on a Modification of the ISTH criteria were reported. Fatal bleeding is defined as any bleeding event that leads to fatal outcome. Critical site bleeding defined as any bleeding event that occurred at critical site such as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal.

  Up to Day 35

Secondary Outcomes (3)

• Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes

  From Day 1 up to Day 35

• Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria

  Up to Day 35

• Number of Participants Who Were Hospitalized or Dead on Day 35

  At Day 35 (+/- 6 days)

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Other: Standard of Care (SOC)

Interventions

Rivaroxaban DRUG

Participants will receive rivaroxaban 10 mg tablet orally once daily.

Also known as: JNJ-39039039, BAY 59-7939

Rivaroxaban

Placebo OTHER

Participants will receive matching placebo tablet orally once daily.

Placebo

Standard of Care (SOC) OTHER

SOC treatment will be determined by the investigator based on local practice and consists of supportive care.

Placebo; Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (17)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Southern California Permanente Medical Group

Los Angeles, California, 90027, United States

Location

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Northshore Universite Healthsystem

Evanston, Illinois, 60201, United States

Location

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Lenox Hill Hospital -Northwell Health

New York, New York, 10075, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Location

Texas Health Physicians Group

Fort Worth, Texas, 76107, United States

Location

Franciscan Research Center

Tacoma, Washington, 98404, United States

Location

Related Publications (2)

• 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.

  PMID: 37154020 RESULT

• 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.

  PMID: 37591523 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Rivaroxaban; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The study was terminated prematurely due to enrollment challenges.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 11, 2020
• Study Start: August 13, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 18, 2023
• Results First Posted: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (17)