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 Southern California
🇺🇸Los Angeles, California, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Zuckerberg San Francisco General
🇺🇸San Francisco, California, United States
Olive View-UCLA Medical Center
🇺🇸Sylmar, California, United States
Pine Ridge Family Medicine
🇺🇸Colorado Springs, Colorado, United States
Life Tree Health, Inc.
🇺🇸Washington, District of Columbia, United States
Midland Florida Clinical Research Center, LLC
🇺🇸DeLand, Florida, United States
University of Florida at Gainesville
🇺🇸Gainesville, Florida, United States
Vital Pharma Research
🇺🇸Hialeah, Florida, United States
Advanced Research for Health Improvement, LLC
🇺🇸Immokalee, Florida, United States
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