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
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

Completed
COVID19

Drug: Apixaban 2.5 MG

Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Other Name: Eliquis

Drug: Placebo

Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Valleywise Health Medical Center
Phoenix, Arizona, United States

Dignity Health-St Josephs
Phoenix, Arizona, United States

Central Arkansas Veterans Health Care System
Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States

Stanford University School of Medicine
Palo Alto, California, United States

New Ananda Medical and Urgent Care, Inc.
S. El Monte, California, United States

UCSF at Zuckerberg San Francisco General Hospital
San Francisco, California, United States

Mazur and Statner MD PC
Thousand Oaks, California, United States

Torrance Medical Center
Torrance, California, United States

Centura Health Porter Adventist Hospital
Denver, Colorado, United States

Saint Anthony Hospital
Lakewood, Colorado, United States

St. Anthony North Health Campus
Westminster, Colorado, United States

Baycare Hospital
Clearwater, Florida, United States

Florida Heart Center
Fort Pierce, Florida, United States

University of Florida
Gainesville, Florida, United States

Mount Sinai Medical Center
Miami Beach, Florida, United States

Tallahassee Memorial HealthCare
Tallahassee, Florida, United States

James A. Haley Veteran's Hospital
Tampa, Florida, United States

BayCare Hospital- Winter Haven
Winter Haven, Florida, United States

Emory University
Atlanta, Georgia, United States

Medical College of Georgia/Augusta University
Augusta, Georgia, United States

Savannah Health Services, LLC DBA Memorial Health University Medical Center
Savannah, Georgia, United States

Queens Medical Center
Honolulu, Hawaii, United States

Hawaii Pacific Health
Honolulu, Hawaii, United States

Snake River Research, PLLC
Idaho Falls, Idaho, United States

University of Illinois at Chicago
Chicago, Illinois, United States

Cook County Health
Chicago, Illinois, United States

Rush University Medical Center
Chicago, Illinois, United States

The University of Chicago Medicine
Chicago, Illinois, United States

OSF Little Company of Mary
Evergreen Park, Illinois, United States

Loyola University Medical Center
Maywood, Illinois, United States

Indiana University Health Bloomington Hospital
Bloomington, Indiana, United States

Lutheran Medical Group
Fort Wayne, Indiana, United States

Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States

Franciscan Health Michigan City
Michigan City, Indiana, United States

Reid Physician Associates
Richmond, Indiana, United States

Baptist Health Lexington
Lexington, Kentucky, United States

University Medical Center New Orleans
New Orleans, Louisiana, United States

Ochsner Clinic Foundation-Baton Rouge
New Orleans, Louisiana, United States

Ochsner Clinic Foundation
New Orleans, Louisiana, United States

Willis-Knighton Physician Network/Tri-State Medical Clinic
Shreveport, Louisiana, United States

Maine Medical Center/Maine Medical Partners Adult Hospital Medicine
Portland, Maine, United States

Pen Bay Medical Center
Rockport, Maine, United States

Anne Arundel Medical Center
Annapolis, Maryland, United States

Lifebridge (Sinai Hospital of Baltimore)
Baltimore, Maryland, United States

Adventist HealthCare Shady Grove Medical Center
Rockville, Maryland, United States

Boston University
Boston, Massachusetts, United States

Lahey Hospital and Medical Center
Burlington, Massachusetts, United States

Baystate Medical center
Springfield, Massachusetts, United States

Bay Regional Medical Center d/b/a/ McLaren Bay Region
Bay City, Michigan, United States

Henry Ford Hospital
Detroit, Michigan, United States

Western Michigan University
Kalamazoo, Michigan, United States

MidMichigan Medical Center
Midland, Michigan, United States

McLaren Macomb
Mount Clemens, Michigan, United States

Minneapolis VA Health Care System
Minneapolis, Minnesota, United States

University of Mississippi Medical Center
Jackson, Mississippi, United States

Truman Medical Center
Kansas City, Missouri, United States

Barnes-Jewish Hospital
Saint Louis, Missouri, United States

St Louis University
Saint Louis, Missouri, United States

Mercury Street Medical Group
Butte, Montana, United States

CHI St Elizabeth Hospital
Lincoln, Nebraska, United States

Renown Health
Reno, Nevada, United States

Dartmouth Hichcock Medical Center
Lebanon, New Hampshire, United States

AtlantiCare Regional Medical Center
Atlantic City, New Jersey, United States

Hope Tower at Jersey Shore University Medical Center
Neptune, New Jersey, United States

Newark Beth Israel Medical Center
Newark, New Jersey, United States

Capital Health System, Inc.
Trenton, New Jersey, United States

Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States

Montefiore Medical Center
Bronx, New York, United States

NYU Langone Hospital-Brooklyn
Brooklyn, New York, United States

Coney Island Hospital
Brooklyn, New York, United States

Buffalo General Medical Center
Buffalo, New York, United States

Mercy Hospital Buffalo
Buffalo, New York, United States

Jamaica Hospital Medical Center
Jamaica, New York, United States

New York University Langone Health
New York, New York, United States

Stony Brook University Hospital
Stony Brook, New York, United States

Westchester Medical Center
Valhalla, New York, United States

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States

Duke Medical Center
Durham, North Carolina, United States

East Carolina University/Vidant Health
Greenville, North Carolina, United States

Wake Med Hospital
Raleigh, North Carolina, United States

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States

Summa Health
Akron, Ohio, United States

University of Cincinnati
Cincinnati, Ohio, United States

Cleveland Clinic Foundation
Cleveland, Ohio, United States

Ohio State University
Columbus, Ohio, United States

Kettering Medical Center
Kettering, Ohio, United States

Ascension St. John Bartlesville
Tulsa, Oklahoma, United States

Ascension St. John Tulsa
Tulsa, Oklahoma, United States

Oregon Health and Science University
Portland, Oregon, United States

St. Luke's University Health Network
Easton, Pennsylvania, United States

Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, United States

Temple University Hospital
Philadelphia, Pennsylvania, United States

University of Pittsburgh
Pittsburgh, Pennsylvania, United States

Tower Health Medical Group
West Reading, Pennsylvania, United States

Rhode Island Hospital
Providence, Rhode Island, United States

The Miriam Hospital
Providence, Rhode Island, United States

Monument Health Clinical Research
Rapid City, South Dakota, United States

Erlanger Health System
Chattanooga, Tennessee, United States

Vanderbilt University Medical Center
Nashville, Tennessee, United States

Christus St. Elizabeth Hospital
Beaumont, Texas, United States

Baylor Scott and White Medical Center- College Station
College Station, Texas, United States

University of Texas Southwestern Medical Center
Dallas, Texas, United States

Texas Health Harris Methodist
Fort Worth, Texas, United States

University of Texas- Houston, LBJ Hospital
Houston, Texas, United States

UT Houston MHH-SW
Houston, Texas, United States

UTHouston
Houston, Texas, United States

Texas Health Frisco
Plano, Texas, United States

Baylor Scott and White-Round Rock
Round Rock, Texas, United States

Baylor Scott and White-Temple
Temple, Texas, United States

The Woodlands Center For Respiratory & Sleep Research
The Woodlands, Texas, United States

CHRISTUS Trinity Clinic Pulmonary Medicine
Tyler, Texas, United States

The University of Texas Health Science Center at Tyler
Tyler, Texas, United States

UT Health East Texas (Tyler)
Tyler, Texas, United States

UT Rio Grande Valley
Weslaco, Texas, United States

MultiCare Institute for Research & Innovation
Puyallup, Washington, United States

UW Medicine Valley Medical Center
Renton, Washington, United States

Virginia Mason Medical Center
Seattle, Washington, United States

CAMC Clinical Trials Center
Charleston, West Virginia, United States

West Virginia University Hospital
Morgantown, West Virginia, United States

Blood Center of Wisconsin
Milwaukee, Wisconsin, United States

Tracy Wang, MD, Principal Investigator
Duke University

National Heart, Lung, and Blood Institute (NHLBI)
NCT Number
MeSH Terms
COVID-19
Thrombosis
Apixaban