Clinical trial NCT04650087: COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis
Official title: COVID-19 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-12-02
Enrollment: 1291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

Detailed description: This study is an adaptive, prospective, randomized platform trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. For Stage 1 of this study, participants will be randomized to either prophylactic anticoagulation or matching placebo for 30 days, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, 90 days).

The primary objective is to determine the most effective and safe antithrombotic strategy to prevent the composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days following discharge from the hospital.

Biobanking of samples for future biomarker and mechanistic studies will be available for centers able to participate and collect samples from eligible participants. Samples will be collected at the time of enrollment and after the completion of 30 days of therapy

Eligibility criteria: Inclusion Criteria:

* • Age ≥ 18 years

  * PCR-positive COVID-19 infection
  * Hospitalized for two or more days

Exclusion Criteria:

* Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)
* Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
* Platelet count \< 50,000/mcL
* Hemoglobin \<8 gm/dL
* Renal insufficiency (eGFR \< 30 mL/min/1.73 m2)
* Pregnancy
* Prison inmate
* Life expectancy less than 90 days
* Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol
* Dual antiplatelet therapy that cannot be discontinued
* Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4

Primary outcomes:
measure: Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.
timeFrame: 30 days after hospital discharge
Secondary outcomes:
measure: The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score.
timeFrame: 30 days after hospital discharge
measure: The Composite Outcome of All-cause Mortality and the EQ5D Index Score.
timeFrame: 90 days after hospital discharge
measure: The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.
timeFrame: 45 days after hospital discharge
measure: The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.
timeFrame: 90 days after hospital discharge
measure: New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records.
timeFrame: 30 days after randomization (which occurred at time of hospital discharge)
measure: New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records.
timeFrame: 30 days after randomization (which occurred at time of hospital discharge)
Other outcomes:
measure: Percentage of Participants With All-cause Mortality
timeFrame: 30 days following discharge from hospital
measure: The Incidence of All-cause Rehospitalization for up to 90 Days After Randomization
timeFrame: 90 days following discharge from hospital
measure: The Individual Domains of EQ5D and the EQ5D Visual Analog Scale for 30 and 90 Days After Randomization
timeFrame: 30 and 90 days following discharge from hospital
Locations:
city: Phoenix
country: United States
facility: Valleywise Health Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Dignity Health-St Josephs
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veterans Health Care System
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: S. El Monte
country: United States
facility: New Ananda Medical and Urgent Care, Inc.
state: California
city: San Francisco
country: United States
facility: UCSF at Zuckerberg San Francisco General Hospital
state: California
city: Thousand Oaks
country: United States
facility: Mazur and Statner MD PC
state: California
city: Torrance
country: United States
facility: Torrance Medical Center
state: California
city: Denver
country: United States
facility: Centura Health Porter Adventist Hospital
state: Colorado
city: Lakewood
country: United States
facility: Saint Anthony Hospital
state: Colorado
city: Westminster
country: United States
facility: St. Anthony North Health Campus
state: Colorado
city: Clearwater
country: United States
facility: Baycare Hospital
state: Florida
city: Fort Pierce
country: United States
facility: Florida Heart Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial HealthCare
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veteran's Hospital
state: Florida
city: Winter Haven
country: United States
facility: BayCare Hospital- Winter Haven
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia/Augusta University
state: Georgia
city: Savannah
country: United States
facility: Savannah Health Services, LLC DBA Memorial Health University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Queens Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Pacific Health
state: Hawaii
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Evergreen Park
country: United States
facility: OSF Little Company of Mary
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Bloomington
country: United States
facility: Indiana University Health Bloomington Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Michigan City
country: United States
facility: Franciscan Health Michigan City
state: Indiana
city: Richmond
country: United States
facility: Reid Physician Associates
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation-Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network/Tri-State Medical Clinic
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center/Maine Medical Partners Adult Hospital Medicine
state: Maine
city: Rockport
country: United States
facility: Pen Bay Medical Center
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Lifebridge (Sinai Hospital of Baltimore)
state: Maryland
city: Rockville
country: United States
facility: Adventist HealthCare Shady Grove Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical center
state: Massachusetts
city: Bay City
country: United States
facility: Bay Regional Medical Center d/b/a/ McLaren Bay Region
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St Louis University
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Lincoln
country: United States
facility: CHI St Elizabeth Hospital
state: Nebraska
city: Reno
country: United States
facility: Renown Health
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hichcock Medical Center
state: New Hampshire
city: Atlantic City
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Hope Tower at Jersey Shore University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Trenton
country: United States
facility: Capital Health System, Inc.
state: New Jersey
city: Santa Fe
country: United States
facility: Christus St. Vincent Regional Medical Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Hospital-Brooklyn
state: New York
city: Brooklyn
country: United States
facility: Coney Island Hospital
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Buffalo
country: United States
facility: Mercy Hospital Buffalo
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: New York
country: United States
facility: New York University Langone Health
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University/Vidant Health
state: North Carolina
city: Raleigh
country: United States
facility: Wake Med Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John Bartlesville
state: Oklahoma
city: Tulsa
country: United States
facility: Ascension St. John Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Easton
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Johnstown
country: United States
facility: Conemaugh Memorial Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: West Reading
country: United States
facility: Tower Health Medical Group
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Rapid City
country: United States
facility: Monument Health Clinical Research
state: South Dakota
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Beaumont
country: United States
facility: Christus St. Elizabeth Hospital
state: Texas
city: College Station
country: United States
facility: Baylor Scott and White Medical Center- College Station
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Harris Methodist
state: Texas
city: Houston
country: United States
facility: University of Texas- Houston, LBJ Hospital
state: Texas
city: Houston
country: United States
facility: UT Houston MHH-SW
state: Texas
city: Houston
country: United States
facility: UTHouston
state: Texas
city: Plano
country: United States
facility: Texas Health Frisco
state: Texas
city: Round Rock
country: United States
facility: Baylor Scott and White-Round Rock
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White-Temple
state: Texas
city: The Woodlands
country: United States
facility: The Woodlands Center For Respiratory & Sleep Research
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Clinic Pulmonary Medicine
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
city: Tyler
country: United States
facility: UT Health East Texas (Tyler)
state: Texas
city: Weslaco
country: United States
facility: UT Rio Grande Valley
state: Texas
city: Puyallup
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Renton
country: United States
facility: UW Medicine Valley Medical Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: Blood Center of Wisconsin
state: Wisconsin
Study officials:
affiliation: Duke University
name: Tracy Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: