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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
657
Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 2.5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
Hospitalization for Cardiovascular/Pulmonary Events
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.
Time frame: 45 days
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Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Aspirin twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study placebo will be shipped to subjects home. Subjects will take placebo twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
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 D.C., 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
...and 61 more locations