COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis
- Registration Number
- NCT04650087
- Lead Sponsor
- Thomas L. Ortel
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1291
-
• Age ≥ 18 years
- PCR-positive COVID-19 infection
- Hospitalized for two or more days
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apixaban Apixaban 2.5 MG 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. Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method 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. 30 days after hospital discharge Composite endpoint (CE) of venous and arterial thrombotic complications-including new, symptomatic proximal, or distal DVT of the upper or lower extremities, PE, and new thrombosis of other veins (including cerebral sinus and splanchnic veins), ischemic stroke, myocardial infarction, other arterial thromboembolism (e.g., mesenteric or acute limb ischemia), and all-cause mortality by day 30.
- Secondary Outcome Measures
Name Time Method New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records. 30 days after randomization (which occurred at time of hospital discharge) New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records. 30 days after randomization (which occurred at time of hospital discharge) The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score. 30 days after hospital discharge Composite endpoint of mortality and EQ5D index at Day 30. All mortality events will be considered worse than any possible EQ5D response \[QOL\&M30\]. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.
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. 90 days after hospital discharge The Composite Outcome of All-cause Mortality and the EQ5D Index Score. 90 days after hospital discharge Composite endpoint of mortality and EQ5D index at Day 90. All mortality events will be considered worse than any possible EQ5D response. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Trial Locations
- Locations (121)
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
The Woodlands Center For Respiratory & Sleep Research
🇺🇸The Woodlands, Texas, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Cook County Health
🇺🇸Chicago, Illinois, United States
Boston University
🇺🇸Boston, Massachusetts, United States
Truman Medical Center
🇺🇸Kansas City, Missouri, United States
Indiana University Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
University of Texas- Houston, LBJ Hospital
🇺🇸Houston, Texas, United States
UTHouston
🇺🇸Houston, Texas, United States
UT Houston MHH-SW
🇺🇸Houston, Texas, United States
St. Anthony North Health Campus
🇺🇸Westminster, Colorado, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Medical College of Georgia/Augusta University
🇺🇸Augusta, Georgia, United States
Torrance Medical Center
🇺🇸Torrance, California, United States
Central Arkansas Veterans Health Care System
🇺🇸Little Rock, Arkansas, United States
New Ananda Medical and Urgent Care, Inc.
🇺🇸S. El Monte, California, United States
Lifebridge (Sinai Hospital of Baltimore)
🇺🇸Baltimore, Maryland, United States
Snake River Research, PLLC
🇺🇸Idaho Falls, Idaho, United States
Mercy Hospital Buffalo
🇺🇸Buffalo, New York, United States
Lutheran Medical Group
🇺🇸Fort Wayne, Indiana, United States
Renown Health
🇺🇸Reno, Nevada, United States
New York University Langone Health
🇺🇸New York, New York, United States
Capital Health System, Inc.
🇺🇸Trenton, New Jersey, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Baystate Medical center
🇺🇸Springfield, Massachusetts, United States
Indiana University Health Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
NYU Langone Hospital-Brooklyn
🇺🇸Brooklyn, New York, United States
St Louis University
🇺🇸Saint Louis, Missouri, United States
Adventist HealthCare Shady Grove Medical Center
🇺🇸Rockville, Maryland, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Hope Tower at Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
East Carolina University/Vidant Health
🇺🇸Greenville, North Carolina, United States
Wake Med Hospital
🇺🇸Raleigh, North Carolina, United States
Pen Bay Medical Center
🇺🇸Rockport, Maine, United States
McLaren Macomb
🇺🇸Mount Clemens, Michigan, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
CHI St Elizabeth Hospital
🇺🇸Lincoln, Nebraska, United States
Summa Health
🇺🇸Akron, Ohio, United States
Maine Medical Center/Maine Medical Partners Adult Hospital Medicine
🇺🇸Portland, Maine, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
Franciscan Health Michigan City
🇺🇸Michigan City, Indiana, United States
Dartmouth Hichcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Baylor Scott and White-Temple
🇺🇸Temple, Texas, United States
UT Rio Grande Valley
🇺🇸Weslaco, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
MidMichigan Medical Center
🇺🇸Midland, Michigan, United States
Tower Health Medical Group
🇺🇸West Reading, Pennsylvania, United States
Texas Health Frisco
🇺🇸Plano, Texas, United States
Christus St. Vincent Regional Medical Center
🇺🇸Santa Fe, New Mexico, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Monument Health Clinical Research
🇺🇸Rapid City, South Dakota, United States
Ascension St. John Tulsa
🇺🇸Tulsa, Oklahoma, United States
Conemaugh Memorial Medical Center
🇺🇸Johnstown, Pennsylvania, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
CHRISTUS Trinity Clinic Pulmonary Medicine
🇺🇸Tyler, Texas, United States
St. Luke's University Health Network
🇺🇸Easton, Pennsylvania, United States
Ascension St. John Bartlesville
🇺🇸Tulsa, Oklahoma, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
Baylor Scott and White-Round Rock
🇺🇸Round Rock, Texas, United States
MultiCare Institute for Research & Innovation
🇺🇸Puyallup, Washington, United States
Texas Health Harris Methodist
🇺🇸Fort Worth, Texas, United States
Christus St. Elizabeth Hospital
🇺🇸Beaumont, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States
UCSF at Zuckerberg San Francisco General Hospital
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Valleywise Health Medical Center
🇺🇸Phoenix, Arizona, United States
Dignity Health-St Josephs
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Centura Health Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Blood Center of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
James A. Haley Veteran's Hospital
🇺🇸Tampa, Florida, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Mazur and Statner MD PC
🇺🇸Thousand Oaks, California, United States
Saint Anthony Hospital
🇺🇸Lakewood, Colorado, United States
Baycare Hospital
🇺🇸Clearwater, Florida, United States
Florida Heart Center
🇺🇸Fort Pierce, Florida, United States
BayCare Hospital- Winter Haven
🇺🇸Winter Haven, Florida, United States
Tallahassee Memorial HealthCare
🇺🇸Tallahassee, Florida, United States
Savannah Health Services, LLC DBA Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
OSF Little Company of Mary
🇺🇸Evergreen Park, Illinois, United States
Reid Physician Associates
🇺🇸Richmond, Indiana, United States
Willis-Knighton Physician Network/Tri-State Medical Clinic
🇺🇸Shreveport, Louisiana, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Bay Regional Medical Center d/b/a/ McLaren Bay Region
🇺🇸Bay City, Michigan, United States
Western Michigan University
🇺🇸Kalamazoo, Michigan, United States
Coney Island Hospital
🇺🇸Brooklyn, New York, United States
AtlantiCare Regional Medical Center
🇺🇸Atlantic City, New Jersey, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Scott and White Medical Center- College Station
🇺🇸College Station, Texas, United States
UT Health East Texas (Tyler)
🇺🇸Tyler, Texas, United States
UW Medicine Valley Medical Center
🇺🇸Renton, Washington, United States
The University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Queens Medical Center
🇺🇸Honolulu, Hawaii, United States
Hawaii Pacific Health
🇺🇸Honolulu, Hawaii, 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
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States