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