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

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Apixaban 2.5 MG
Apixaban 5MG
Aspirin
Placebo
Sponsored by
Frank C Sciurba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

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

Exclusion:

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

Sites / Locations

  • University of Southern California
  • Stanford University School of Medicine
  • Zuckerberg San Francisco General
  • Olive View-UCLA Medical Center
  • Pine Ridge Family Medicine
  • Life Tree Health, Inc.
  • Midland Florida Clinical Research Center, LLC
  • University of Florida at Gainesville
  • Vital Pharma Research
  • Advanced Research for Health Improvement, LLC
  • University of Floridia at Jacksonville
  • Lakeland Regional
  • Total Research Group LLC
  • Jackson Memorial
  • Well Pharma Medical Research
  • Innovation Clinical Trials
  • Bond Community Health Center
  • Tallahassee Memorial
  • USF Tampa General Hospital
  • Alliance Clinical Research
  • Hawaii Pacific Health
  • Fox Valley Clinical Research Center, LLC
  • UIC - Mile Square
  • Jesse Brown VA
  • University of Illinois at Chicago
  • Olivo Wellness Medical Center
  • University of Chicago
  • OSF Saint Francis Medical Center
  • Ascension Via Christi
  • University Medical Center New Orleans
  • Jadestone Clinical Research, LLC
  • Brigham & Women's Hospital
  • GFC of Southeastern Michigan
  • SRI International
  • Metro Health-University of Michigan Health
  • Raritan Bay Primary Care and Cardiology Associates
  • G&S Medical Associates, LLC
  • University of New Mexico
  • Montefiore Medical Center
  • Strong Memorial
  • Spinal Pain and Rehab Medicine
  • Duke
  • Peters Medical Research
  • The Heart and Medical Center
  • Ascension St. John Clinical Research Institute
  • UPMC Passavant Cranberry
  • UPMC McKeesport
  • UPMC East
  • UPMC Magee
  • UPMC Presby
  • UPMC Mercy
  • Preferred Primary Care Physicians
  • UPMC Shadyside
  • UPMC Passavant McCandless
  • Preferred Primary Care Physicians, Inc
  • Preferred Primary Care Physicians
  • Preferred Primary Care Physicians
  • Pharma Tex Research
  • Ascension Seton Medical Center
  • Baptist Beaumont
  • McGoven Medical School - UT- Houston
  • Diversifield Medical Practices
  • Next Level Urgent Care
  • Mesquite Regional Internal Medicine
  • University of Texas at Tyler
  • University of Texas at Rio Grande Valley
  • Intermountain Healthcare
  • Community Care of Clay
  • University Healthcare Physicians
  • Community Care of Weston
  • Gundersen Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Apixaban 2.5mg

Apixaban 5mg

Aspirin

Placebo

Arm Description

Anticoagulation: prophylactic dose Apixaban 2.5mg po bid

Anticoagulation: therapeutic dose Apixaban 5.0mg po bid

Antiplatelet agent: low dose aspirin 81mg po qd

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2020
Last Updated
February 15, 2022
Sponsor
Frank C Sciurba
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04498273
Brief Title
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
an event rate lower than anticipated
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
August 5, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frank C Sciurba
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
657 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban 2.5mg
Arm Type
Active Comparator
Arm Description
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
Arm Title
Apixaban 5mg
Arm Type
Active Comparator
Arm Description
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Antiplatelet agent: low dose aspirin 81mg po qd
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Apixaban 2.5 MG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Apixaban 5MG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospitalization for Cardiovascular/Pulmonary Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Sciurba
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Zuckerberg San Francisco General
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Pine Ridge Family Medicine
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80924
Country
United States
Facility Name
Life Tree Health, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20020
Country
United States
Facility Name
Midland Florida Clinical Research Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
23720
Country
United States
Facility Name
University of Florida at Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Vital Pharma Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Advanced Research for Health Improvement, LLC
City
Immokalee
State/Province
Florida
ZIP/Postal Code
34142
Country
United States
Facility Name
University of Floridia at Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Lakeland Regional
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Total Research Group LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Jackson Memorial
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Well Pharma Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Innovation Clinical Trials
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Bond Community Health Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32301
Country
United States
Facility Name
Tallahassee Memorial
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
USF Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Alliance Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Hawaii Pacific Health
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Fox Valley Clinical Research Center, LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506
Country
United States
Facility Name
UIC - Mile Square
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Jesse Brown VA
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Olivo Wellness Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60618
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Ascension Via Christi
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Jadestone Clinical Research, LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
GFC of Southeastern Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
SRI International
City
Plymouth
State/Province
Michigan
ZIP/Postal Code
48170
Country
United States
Facility Name
Metro Health-University of Michigan Health
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Raritan Bay Primary Care and Cardiology Associates
City
Matawan
State/Province
New Jersey
ZIP/Postal Code
07747
Country
United States
Facility Name
G&S Medical Associates, LLC
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07514
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Strong Memorial
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Spinal Pain and Rehab Medicine
City
Yonkers
State/Province
New York
ZIP/Postal Code
10701
Country
United States
Facility Name
Duke
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
The Heart and Medical Center
City
Durant
State/Province
Oklahoma
ZIP/Postal Code
74701
Country
United States
Facility Name
Ascension St. John Clinical Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
UPMC Passavant Cranberry
City
Cranberry
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
UPMC McKeesport
City
McKeesport
State/Province
Pennsylvania
ZIP/Postal Code
15132
Country
United States
Facility Name
UPMC East
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
UPMC Magee
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Presby
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Mercy
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Passavant McCandless
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Pharma Tex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
Ascension Seton Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Baptist Beaumont
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
McGoven Medical School - UT- Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Diversifield Medical Practices
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Next Level Urgent Care
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Mesquite Regional Internal Medicine
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
University of Texas at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
University of Texas at Rio Grande Valley
City
Weslaco
State/Province
Texas
ZIP/Postal Code
78596
Country
United States
Facility Name
Intermountain Healthcare
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Community Care of Clay
City
Clay
State/Province
West Virginia
ZIP/Postal Code
25043
Country
United States
Facility Name
University Healthcare Physicians
City
Harpers Ferry
State/Province
West Virginia
ZIP/Postal Code
25425
Country
United States
Facility Name
Community Care of Weston
City
Weston
State/Province
West Virginia
ZIP/Postal Code
26452
Country
United States
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34633405
Citation
Connors JM, Brooks MM, Sciurba FC, Krishnan JA, Bledsoe JR, Kindzelski A, Baucom AL, Kirwan BA, Eng H, Martin D, Zaharris E, Everett B, Castro L, Shapiro NL, Lin JY, Hou PC, Pepine CJ, Handberg E, Haight DO, Wilson JW, Majercik S, Fu Z, Zhong Y, Venugopal V, Beach S, Wisniewski S, Ridker PM; ACTIV-4B Investigators. Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1703-1712. doi: 10.1001/jama.2021.17272.
Results Reference
derived
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived

Learn more about this trial

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

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