COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis
Covid19
About this trial
This is an interventional prevention trial for Covid19
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
Sites / Locations
- Valleywise Health Medical Center
- Dignity Health-St Josephs
- Central Arkansas Veterans Health Care System
- University of Arkansas for Medical Sciences
- Stanford University School of Medicine
- New Ananda Medical and Urgent Care, Inc.
- UCSF at Zuckerberg San Francisco General Hospital
- Mazur and Statner MD PC
- Torrance Medical Center
- Centura Health Porter Adventist Hospital
- Saint Anthony Hospital
- St. Anthony North Health Campus
- Baycare Hospital
- Florida Heart Center
- University of Florida
- Mount Sinai Medical Center
- Tallahassee Memorial HealthCare
- James A. Haley Veteran's Hospital
- BayCare Hospital- Winter Haven
- Emory University
- Medical College of Georgia/Augusta University
- Savannah Health Services, LLC DBA Memorial Health University Medical Center
- Queens Medical Center
- Hawaii Pacific Health
- Snake River Research, PLLC
- University of Illinois at Chicago
- Cook County Health
- Rush University Medical Center
- The University of Chicago Medicine
- OSF Little Company of Mary
- Loyola University Medical Center
- Indiana University Health Bloomington Hospital
- Lutheran Medical Group
- Indiana University Health Methodist Hospital
- Franciscan Health Michigan City
- Reid Physician Associates
- Baptist Health Lexington
- University Medical Center New Orleans
- Ochsner Clinic Foundation-Baton Rouge
- Ochsner Clinic Foundation
- Willis-Knighton Physician Network/Tri-State Medical Clinic
- Maine Medical Center/Maine Medical Partners Adult Hospital Medicine
- Pen Bay Medical Center
- Anne Arundel Medical Center
- Lifebridge (Sinai Hospital of Baltimore)
- Adventist HealthCare Shady Grove Medical Center
- Boston University
- Lahey Hospital and Medical Center
- Baystate Medical center
- Bay Regional Medical Center d/b/a/ McLaren Bay Region
- Henry Ford Hospital
- Western Michigan University
- MidMichigan Medical Center
- McLaren Macomb
- Minneapolis VA Health Care System
- University of Mississippi Medical Center
- Truman Medical Center
- Barnes-Jewish Hospital
- St Louis University
- Mercury Street Medical Group
- CHI St Elizabeth Hospital
- Renown Health
- Dartmouth Hichcock Medical Center
- AtlantiCare Regional Medical Center
- Hope Tower at Jersey Shore University Medical Center
- Newark Beth Israel Medical Center
- Capital Health System, Inc.
- Christus St. Vincent Regional Medical Center
- Montefiore Medical Center
- NYU Langone Hospital-Brooklyn
- Coney Island Hospital
- Buffalo General Medical Center
- Mercy Hospital Buffalo
- Jamaica Hospital Medical Center
- New York University Langone Health
- Stony Brook University Hospital
- Westchester Medical Center
- University of North Carolina at Chapel Hill
- Duke Medical Center
- East Carolina University/Vidant Health
- Wake Med Hospital
- Wake Forest Baptist Medical Center
- Summa Health
- University of Cincinnati
- Cleveland Clinic Foundation
- Ohio State University
- Kettering Medical Center
- Ascension St. John Bartlesville
- Ascension St. John Tulsa
- Oregon Health and Science University
- St. Luke's University Health Network
- Conemaugh Memorial Medical Center
- Temple University Hospital
- University of Pittsburgh
- Tower Health Medical Group
- Rhode Island Hospital
- The Miriam Hospital
- Monument Health Clinical Research
- Erlanger Health System
- Vanderbilt University Medical Center
- Christus St. Elizabeth Hospital
- Baylor Scott and White Medical Center- College Station
- University of Texas Southwestern Medical Center
- Texas Health Harris Methodist
- University of Texas- Houston, LBJ Hospital
- UT Houston MHH-SW
- UTHouston
- Texas Health Frisco
- Baylor Scott and White-Round Rock
- Baylor Scott and White-Temple
- The Woodlands Center For Respiratory & Sleep Research
- CHRISTUS Trinity Clinic Pulmonary Medicine
- The University of Texas Health Science Center at Tyler
- UT Health East Texas (Tyler)
- UT Rio Grande Valley
- MultiCare Institute for Research & Innovation
- UW Medicine Valley Medical Center
- Virginia Mason Medical Center
- CAMC Clinical Trials Center
- West Virginia University Hospital
- Blood Center of Wisconsin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Apixaban
Placebo
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. 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 contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 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.
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the 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 contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 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.