Study Stopped
an event rate lower than anticipated
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
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
1 other identifier
interventional
657
1 country
71
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Sep 2020
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedStudy Start
First participant enrolled
September 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2021
CompletedResults Posted
Study results publicly available
February 17, 2022
CompletedFebruary 17, 2022
February 1, 2022
11 months
August 3, 2020
January 14, 2022
February 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
45 days
Study Arms (4)
Apixaban 2.5mg
ACTIVE COMPARATORAnticoagulation: prophylactic dose Apixaban 2.5mg po bid
Apixaban 5mg
ACTIVE COMPARATORAnticoagulation: therapeutic dose Apixaban 5.0mg po bid
Aspirin
ACTIVE COMPARATORAntiplatelet agent: low dose aspirin 81mg po qd
Placebo
PLACEBO COMPARATORPlacebo
Interventions
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.
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.
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.
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
You may qualify if:
- COVID-19+ in past 14 days
- Platelets \> 100,000
- eGFR \> 30ml/min
You may not qualify if:
- Hospitalized
- Contradiction/ other indication for anti-coagulation
- Pregnancy
- Active cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Frank C Sciurbalead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (71)
University of Southern California
Los Angeles, California, 90033, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
Zuckerberg San Francisco General
San Francisco, California, 94143, United States
Olive View-UCLA Medical Center
Sylmar, California, 91342, United States
Pine Ridge Family Medicine
Colorado Springs, Colorado, 80924, United States
Life Tree Health, Inc.
Washington D.C., District of Columbia, 20020, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 23720, United States
University of Florida at Gainesville
Gainesville, Florida, 32611, United States
Vital Pharma Research
Hialeah, Florida, 33016, United States
Advanced Research for Health Improvement, LLC
Immokalee, Florida, 34142, United States
University of Floridia at Jacksonville
Jacksonville, Florida, 32209, United States
Lakeland Regional
Lakeland, Florida, 33805, United States
Total Research Group LLC
Miami, Florida, 33126, United States
Jackson Memorial
Miami, Florida, 33136, United States
Well Pharma Medical Research
Miami, Florida, 33173, United States
Innovation Clinical Trials
Palmetto Bay, Florida, 33157, United States
Bond Community Health Center
Tallahassee, Florida, 32301, United States
Tallahassee Memorial
Tallahassee, Florida, 32308, United States
USF Tampa General Hospital
Tampa, Florida, 33606, United States
Alliance Clinical Research
Tampa, Florida, 33615, United States
Hawaii Pacific Health
Honolulu, Hawaii, 96813, United States
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, 60506, United States
UIC - Mile Square
Chicago, Illinois, 60608, United States
Jesse Brown VA
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Olivo Wellness Medical Center
Chicago, Illinois, 60618, United States
University of Chicago
Chicago, Illinois, 60637, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Ascension Via Christi
Wichita, Kansas, 67214, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Jadestone Clinical Research, LLC
Gaithersburg, Maryland, 20877, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
GFC of Southeastern Michigan
Detroit, Michigan, 48202, United States
SRI International
Plymouth, Michigan, 48170, United States
Metro Health-University of Michigan Health
Wyoming, Michigan, 49519, United States
Raritan Bay Primary Care and Cardiology Associates
Matawan, New Jersey, 07747, United States
G&S Medical Associates, LLC
Paterson, New Jersey, 07514, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Strong Memorial
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Spinal Pain and Rehab Medicine
Yonkers, New York, 10701, United States
Duke
Durham, North Carolina, 27701, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
The Heart and Medical Center
Durant, Oklahoma, 74701, United States
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma, 74104, United States
UPMC Passavant Cranberry
Cranberry, Pennsylvania, 16066, United States
UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
UPMC East
Monroeville, Pennsylvania, 15146, United States
UPMC Magee
Pittsburgh, Pennsylvania, 15213, United States
UPMC Presby
Pittsburgh, Pennsylvania, 15213, United States
UPMC Mercy
Pittsburgh, Pennsylvania, 15219, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15220, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232, United States
UPMC Passavant McCandless
Pittsburgh, Pennsylvania, 15237, United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15243, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15243, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Pharma Tex Research
Amarillo, Texas, 79109, United States
Ascension Seton Medical Center
Austin, Texas, 78752, United States
Baptist Beaumont
Beaumont, Texas, 77030, United States
McGoven Medical School - UT- Houston
Houston, Texas, 77030, United States
Diversifield Medical Practices
Houston, Texas, 77057, United States
Next Level Urgent Care
Houston, Texas, 77057, United States
Mesquite Regional Internal Medicine
Mesquite, Texas, 75149, United States
University of Texas at Tyler
Tyler, Texas, 75708, United States
University of Texas at Rio Grande Valley
Weslaco, Texas, 78596, United States
Intermountain Healthcare
Murray, Utah, 84107, United States
Community Care of Clay
Clay, West Virginia, 25043, United States
University Healthcare Physicians
Harpers Ferry, West Virginia, 25425, United States
Community Care of Weston
Weston, West Virginia, 26452, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
Related Publications (5)
Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
PMID: 37591523DERIVEDFischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
PMID: 37489818DERIVEDBledsoe J, Woller SC, Brooks M, Sciurba FC, Krishnan JA, Martin D, Hou P, Lin JY, Kindzelski A, Handberg E, Kirwan BA, Zaharris E, Castro L, Shapiro NL, Pepine CJ, Majercik S, Fu Z, Zhong Y, Venugopal V, Lai YH, Ridker PM, Connors JM. Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial. BMC Infect Dis. 2023 May 15;23(1):325. doi: 10.1186/s12879-023-08295-9.
PMID: 37189091DERIVEDConnors 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.
PMID: 34633405DERIVEDKreuzberger 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.
PMID: 34473343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leads to a small number of subjects being analyzed.
Results Point of Contact
- Title
- Dr. Frank Sciurba
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Sciurba
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 3, 2020
First Posted
August 4, 2020
Study Start
September 7, 2020
Primary Completion
August 5, 2021
Study Completion
August 5, 2021
Last Updated
February 17, 2022
Results First Posted
February 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share