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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 COVID-19 Infection (PREVENT-HD)
Overall Recruitment Status: Active, currently enrolling
 
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
 
Region Sponsors
California - Northern
Janssen Scientific Affairs, LLC
 
Acronym KP IRB No.
PREVENT-HD 1665445
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Outpatient adults who are symptomatic with laboratory-confirmed coronavirus disease 2019 (COVID-19)
 
Purpose
The purpose of this pragmatic randomized clinical trial is to evaluate whether rivaroxaban (10 mg/day) 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
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.
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Coronavirus disease 2019 (COVID-19) confirmed by a locally-obtained approved viral diagnostic test (for example, polymerase chain reaction [PCR])
  • An active member of Kaiser Permanente Northern California
  • Symptoms attributable to COVID-19 (for 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 for thrombosis: (a) age >=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) >=35 kilogram per meter square (kg/m^2), (k) D-dimer >= 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 treatment for cancer
  • Any illness or condition that in the opinion of the investigator would significantly increase the risk of bleeding (for 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 other inactive substances in the pill
  • Positive COVID-19 antibody or serology test after a 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

 
Keywords and/or Specific Medical Conditions
  • Anticoagulants
  • Nidovirales Infections
  • Antithrombins
  • Protease Inhibitors
  • Coronaviridae Infections
  • Rivaroxaban
  • Coronavirus Infections
  • RNA Virus Infections
  • Enzyme Inhibitors
  • Serine Proteinase Inhibitors
  • Factor Xa Inhibitors
  • Virus Diseases
  • Molecular Mechanisms of Pharmacological Action
  • Infectious Diseases
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Infectious Diseases


Principal Investigator:
Alan S Go, MD
Contact Information:
- Sue Hee Sung, MPH
-sue.hee.sung@kp.org
-Regional Locations-DOR


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