COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT04498273
- Lead Sponsor
- Frank C Sciurba
- Brief Summary
A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis
- Detailed Description
The COVID-19 Outpatient Thrombosis Prevention Trial is a multi-center adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anti-coagulation with anti-platelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who have evidence of increased inflammation based on elevated D-dimer and hsCRP levels, yet are not admitted to hospital as COVID-19 related symptoms are currently stable. Participants will all be adults between 40 and 79 years who will be enrolled from approximately 100 facilities, such as emergency rooms and other settings where a physician is present to evaluate the patient for inclusion and exclusion criteria.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 657
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Apixaban 2.5mg Apixaban 2.5 MG Anticoagulation: prophylactic dose Apixaban 2.5mg po bid Apixaban 5mg Apixaban 5MG Anticoagulation: therapeutic dose Apixaban 5.0mg po bid Aspirin Aspirin Antiplatelet agent: low dose aspirin 81mg po qd
- Primary Outcome Measures
Name Time Method Hospitalization for Cardiovascular/Pulmonary Events 45 days The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (69)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Olivo Wellness Medical Center
🇺🇸Chicago, Illinois, United States
UPMC Presby
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
Diversifield Medical Practices
🇺🇸Houston, Texas, United States
Ascension Via Christi
🇺🇸Wichita, Kansas, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Life Tree Health, Inc.
🇺🇸Washington, District of Columbia, United States
Innovation Clinical Trials
🇺🇸Palmetto Bay, Florida, United States
Raritan Bay Primary Care and Cardiology Associates
🇺🇸Matawan, New Jersey, United States
UIC - Mile Square
🇺🇸Chicago, Illinois, United States
Vital Pharma Research
🇺🇸Hialeah, Florida, United States
University of Floridia at Jacksonville
🇺🇸Jacksonville, Florida, United States
UPMC Passavant Cranberry
🇺🇸Cranberry, Pennsylvania, United States
Olive View-UCLA Medical Center
🇺🇸Sylmar, California, United States
Jesse Brown VA
🇺🇸Chicago, Illinois, United States
Tallahassee Memorial
🇺🇸Tallahassee, Florida, United States
Midland Florida Clinical Research Center, LLC
🇺🇸DeLand, Florida, United States
UPMC Magee
🇺🇸Pittsburgh, Pennsylvania, United States
Ascension St. John Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
Metro Health-University of Michigan Health
🇺🇸Wyoming, Michigan, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
McGoven Medical School - UT- Houston
🇺🇸Houston, Texas, United States
UPMC Passavant McCandless
🇺🇸Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Pine Ridge Family Medicine
🇺🇸Colorado Springs, Colorado, United States
Advanced Research for Health Improvement, LLC
🇺🇸Immokalee, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Jadestone Clinical Research, LLC
🇺🇸Gaithersburg, Maryland, United States
Spinal Pain and Rehab Medicine
🇺🇸Yonkers, New York, United States
UPMC McKeesport
🇺🇸McKeesport, Pennsylvania, United States
Pharma Tex Research
🇺🇸Amarillo, Texas, United States
Baptist Beaumont
🇺🇸Beaumont, Texas, United States
Mesquite Regional Internal Medicine
🇺🇸Mesquite, Texas, United States
Next Level Urgent Care
🇺🇸Houston, Texas, United States
University of Texas at Rio Grande Valley
🇺🇸Weslaco, Texas, United States
Intermountain Healthcare
🇺🇸Murray, Utah, United States
Community Care of Clay
🇺🇸Clay, West Virginia, United States
Gundersen Health System
🇺🇸La Crosse, Wisconsin, United States
University Healthcare Physicians
🇺🇸Harpers Ferry, West Virginia, United States
Community Care of Weston
🇺🇸Weston, West Virginia, United States
Lakeland Regional
🇺🇸Lakeland, Florida, United States
UPMC East
🇺🇸Monroeville, Pennsylvania, United States
Bond Community Health Center
🇺🇸Tallahassee, Florida, United States
Strong Memorial
🇺🇸Rochester, New York, United States
Fox Valley Clinical Research Center, LLC
🇺🇸Aurora, Illinois, United States
SRI International
🇺🇸Plymouth, Michigan, United States
The Heart and Medical Center
🇺🇸Durant, Oklahoma, United States
University of Texas at Tyler
🇺🇸Tyler, Texas, United States
UPMC Mercy
🇺🇸Pittsburgh, Pennsylvania, United States
G&S Medical Associates, LLC
🇺🇸Paterson, New Jersey, United States
Hawaii Pacific Health
🇺🇸Honolulu, Hawaii, United States
Duke
🇺🇸Durham, North Carolina, United States
Jackson Memorial
🇺🇸Miami, Florida, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
University of Florida at Gainesville
🇺🇸Gainesville, Florida, United States
Total Research Group LLC
🇺🇸Miami, Florida, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
USF Tampa General Hospital
🇺🇸Tampa, Florida, United States
GFC of Southeastern Michigan
🇺🇸Detroit, Michigan, United States
Zuckerberg San Francisco General
🇺🇸San Francisco, California, United States
Well Pharma Medical Research
🇺🇸Miami, Florida, United States
Alliance Clinical Research
🇺🇸Tampa, Florida, United States
Ascension Seton Medical Center
🇺🇸Austin, Texas, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States