COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80

February 15, 2022 updated by: Frank C Sciurba

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

657

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
      • San Francisco, California, United States, 94143
        • Zuckerberg San Francisco General
      • Sylmar, California, United States, 91342
        • Olive View-UCLA Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80924
        • Pine Ridge Family Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20020
        • Life Tree Health, Inc.
    • Florida
      • DeLand, Florida, United States, 23720
        • Midland Florida Clinical Research Center, LLC
      • Gainesville, Florida, United States, 32611
        • University of Florida at Gainesville
      • Hialeah, Florida, United States, 33016
        • Vital Pharma Research
      • Immokalee, Florida, United States, 34142
        • Advanced Research for Health Improvement, LLC
      • Jacksonville, Florida, United States, 32209
        • University of Floridia at Jacksonville
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional
      • Miami, Florida, United States, 33173
        • Well Pharma Medical Research
      • Miami, Florida, United States, 33126
        • Total Research Group LLC
      • Miami, Florida, United States, 33136
        • Jackson Memorial
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Clinical Trials
      • Tallahassee, Florida, United States, 32301
        • Bond Community Health Center
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial
      • Tampa, Florida, United States, 33606
        • USF Tampa General Hospital
      • Tampa, Florida, United States, 33615
        • Alliance Clinical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Pacific Health
    • Illinois
      • Aurora, Illinois, United States, 60506
        • Fox Valley Clinical Research Center, LLC
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60608
        • UIC - Mile Square
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA
      • Chicago, Illinois, United States, 60618
        • Olivo Wellness Medical Center
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Jadestone Clinical Research, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GFC of Southeastern Michigan
      • Plymouth, Michigan, United States, 48170
        • SRI International
      • Wyoming, Michigan, United States, 49519
        • Metro Health-University of Michigan Health
    • New Jersey
      • Matawan, New Jersey, United States, 07747
        • Raritan Bay Primary Care and Cardiology Associates
      • Paterson, New Jersey, United States, 07514
        • G&S Medical Associates, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Rochester, New York, United States, 14642
        • Strong Memorial
      • Yonkers, New York, United States, 10701
        • Spinal Pain and Rehab Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
    • Oklahoma
      • Durant, Oklahoma, United States, 74701
        • The Heart and Medical Center
      • Tulsa, Oklahoma, United States, 74104
        • Ascension St. John Clinical Research Institute
    • Pennsylvania
      • Cranberry, Pennsylvania, United States, 16066
        • UPMC Passavant Cranberry
      • McKeesport, Pennsylvania, United States, 15132
        • UPMC McKeesport
      • Monroeville, Pennsylvania, United States, 15146
        • UPMC East
      • Pittsburgh, Pennsylvania, United States, 15219
        • UPMC Mercy
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Shadyside
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Magee
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presby
      • Pittsburgh, Pennsylvania, United States, 15220
        • Preferred Primary Care Physicians
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC Passavant McCandless
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians, Inc
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • Texas
      • Amarillo, Texas, United States, 79109
        • Pharma Tex Research
      • Austin, Texas, United States, 78752
        • Ascension Seton Medical Center
      • Beaumont, Texas, United States, 77030
        • Baptist Beaumont
      • Houston, Texas, United States, 77057
        • Next Level Urgent Care
      • Houston, Texas, United States, 77030
        • McGoven Medical School - UT- Houston
      • Houston, Texas, United States, 77057
        • Diversifield Medical Practices
      • Mesquite, Texas, United States, 75149
        • Mesquite Regional Internal Medicine
      • Tyler, Texas, United States, 75708
        • University of Texas at Tyler
      • Weslaco, Texas, United States, 78596
        • University of Texas at Rio Grande Valley
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Healthcare
    • West Virginia
      • Clay, West Virginia, United States, 25043
        • Community Care of Clay
      • Harpers Ferry, West Virginia, United States, 25425
        • University Healthcare Physicians
      • Weston, West Virginia, United States, 26452
        • Community Care of Weston
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • COVID-19+ in past 14 days
  • Platelets > 100,000
  • eGFR > 30ml/min

Exclusion:

  • Hospitalized
  • Contradiction/ other indication for anti-coagulation
  • Pregnancy
  • Active cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Active Comparator: Apixaban 2.5mg
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
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.
Active Comparator: Apixaban 5mg
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
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.
Active Comparator: Aspirin
Antiplatelet agent: low dose aspirin 81mg po qd
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization for Cardiovascular/Pulmonary Events
Time Frame: 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.
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frank C Sciurba

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Frank Sciurba, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Actual)

August 5, 2021

Study Completion (Actual)

August 5, 2021

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIV4-Outpatient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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