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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
657

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frank C Sciurba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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