Official Title
COVID-19 Outpatient Thrombosis Prevention Trial A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID Adults Not Requiring Hospitalization at Time of Diagnosis
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.

Terminated
COVID-19

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.

Eligibility Criteria

Inclusion:

- COVID-19+ in past 14 days

- Platelets > 100,000

- eGFR > 30ml/min

Exclusion:

- Hospitalized

- Contradiction/ other indication for anti-coagulation

- Pregnancy

- Active cancer

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years ~ Maximum: 80 Years
Countries
United States
Locations

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

National Heart, Lung, and Blood Institute (NHLBI)
NCT Number
MeSH Terms
COVID-19
Thrombosis
Aspirin
Apixaban