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.
Drug: Apixaban 2.5 MG
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.
Drug: Apixaban 5MG
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.
Drug: Aspirin
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.
Drug: Placebo
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.
Inclusion:
- COVID-19+ in past 14 days
- Platelets > 100,000
- eGFR > 30ml/min
Exclusion:
- Hospitalized
- Contradiction/ other indication for anti-coagulation
- Pregnancy
- Active cancer
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
University of Floridia at Jacksonville
Jacksonville, Florida, United States
Lakeland Regional
Lakeland, Florida, United States
Total Research Group LLC
Miami, Florida, United States
Jackson Memorial
Miami, Florida, United States
Well Pharma Medical Research
Miami, Florida, United States
Innovation Clinical Trials
Palmetto Bay, Florida, United States
Bond Community Health Center
Tallahassee, Florida, United States
Tallahassee Memorial
Tallahassee, Florida, United States
USF Tampa General Hospital
Tampa, Florida, United States
Alliance Clinical Research
Tampa, Florida, United States
Hawaii Pacific Health
Honolulu, Hawaii, United States
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, United States
UIC - Mile Square
Chicago, Illinois, United States
Jesse Brown VA
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Olivo Wellness Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Ascension Via Christi
Wichita, Kansas, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Jadestone Clinical Research, LLC
Gaithersburg, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
GFC of Southeastern Michigan
Detroit, Michigan, United States
SRI International
Plymouth, Michigan, United States
Metro Health-University of Michigan Health
Wyoming, Michigan, United States
Raritan Bay Primary Care and Cardiology Associates
Matawan, New Jersey, United States
G&S Medical Associates, LLC
Paterson, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Montefiore Medical Center
Bronx, New York, United States
Strong Memorial
Rochester, New York, United States
Spinal Pain and Rehab Medicine
Yonkers, New York, United States
Duke
Durham, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
The Heart and Medical Center
Durant, Oklahoma, United States
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma, United States
UPMC Passavant Cranberry
Cranberry, Pennsylvania, United States
UPMC McKeesport
McKeesport, Pennsylvania, United States
UPMC East
Monroeville, Pennsylvania, United States
UPMC Magee
Pittsburgh, Pennsylvania, United States
UPMC Presby
Pittsburgh, Pennsylvania, United States
UPMC Mercy
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
UPMC Passavant McCandless
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Pharma Tex Research
Amarillo, Texas, United States
Ascension Seton Medical Center
Austin, Texas, United States
Baptist Beaumont
Beaumont, Texas, United States
McGoven Medical School - UT- Houston
Houston, Texas, United States
Diversifield Medical Practices
Houston, Texas, United States
Next Level Urgent Care
Houston, Texas, United States
Mesquite Regional Internal Medicine
Mesquite, Texas, United States
University of Texas at Tyler
Tyler, 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
University Healthcare Physicians
Harpers Ferry, West Virginia, United States
Community Care of Weston
Weston, West Virginia, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Frank Sciurba, Principal Investigator
University of Pittsburgh