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Covid19Phase 3NCT04650087

COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

A Phase 3 study testing Apixaban 2.5 MG in people with Covid19, run by Thomas L. Ortel at 121 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Apixaban 2.5 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,291 participants
Where
121 sitesUnited States
Study dates
15 Feb 2021to 23 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Age ≥ 18 years
  • PCR-positive COVID-19 infection
  • Hospitalized for two or more days

Who cannot join

  • Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)
  • Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
  • Platelet count < 50,000/mcL
  • Hemoglobin <8 gm/dL
  • Renal insufficiency (eGFR < 30 mL/min/1.73 m2)
  • Pregnancy
Show all 11Show fewer
  • Prison inmate
  • Life expectancy less than 90 days
  • Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol
  • Dual antiplatelet therapy that cannot be discontinued
  • Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

United States121 sites

  • Summa Health

    Akron, Ohio, 44304

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Emory University

    Atlanta, Georgia, 30308

  • AtlantiCare Regional Medical Center

    Atlantic City, New Jersey, 08401

  • Medical College of Georgia/Augusta University

    Augusta, Georgia, 30912

  • Lifebridge (Sinai Hospital of Baltimore)

    Baltimore, Maryland, 21215

  • Bay Regional Medical Center d/b/a/ McLaren Bay Region

    Bay City, Michigan, 48708

  • Christus St. Elizabeth Hospital

    Beaumont, Texas, 77702

  • Indiana University Health Bloomington Hospital

    Bloomington, Indiana, 47403

  • Boston University

    Boston, Massachusetts, 02118

  • NYU Langone Hospital-Brooklyn

    Brooklyn, New York, 111220

  • Coney Island Hospital

    Brooklyn, New York, 11235

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Mercy Hospital Buffalo

    Buffalo, New York, 14220

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Mercury Street Medical Group

    Butte, Montana, 59701

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • CAMC Clinical Trials Center

    Charleston, West Virginia, 25304

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • University of Illinois at Chicago

    Chicago, Illinois, 60607

  • Cook County Health

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Baycare Hospital

    Clearwater, Florida, 33756

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Baylor Scott and White Medical Center- College Station

    College Station, Texas, 77845

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Centura Health Porter Adventist Hospital

    Denver, Colorado, 80210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke Medical Center

    Durham, North Carolina, 27710

  • St. Luke's University Health Network

    Easton, Pennsylvania, 18045

  • OSF Little Company of Mary

    Evergreen Park, Illinois, 60805

  • Lutheran Medical Group

    Fort Wayne, Indiana, 46804

  • Texas Health Harris Methodist

    Fort Worth, Texas, 76104

  • Florida Heart Center

    Ft. Pierce, Florida, 34590

  • University of Florida

    Gainesville, Florida, 32610

  • East Carolina University/Vidant Health

    Greenville, North Carolina, 27858

  • Queens Medical Center

    Honolulu, Hawaii, 96813

  • Hawaii Pacific Health

    Honolulu, Hawaii, 96827

  • University of Texas- Houston, LBJ Hospital

    Houston, Texas, 77030

  • UT Houston MHH-SW

    Houston, Texas, 77030

  • UTHouston

    Houston, Texas, 77030

  • Snake River Research, PLLC

    Idaho Falls, Idaho, 83404

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Conemaugh Memorial Medical Center

    Johnstown, Pennsylvania, 15905

  • Western Michigan University

    Kalamazoo, Michigan, 49008

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Dartmouth Hichcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • CHI St Elizabeth Hospital

    Lincoln, Nebraska, 68510

  • Central Arkansas Veterans Health Care System

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Franciscan Health Michigan City

    Michigan City, Indiana, 46360

  • MidMichigan Medical Center

    Midland, Michigan, 48670

  • Blood Center of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota, 55417

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • McLaren Macomb

    Mount Clemens, Michigan, 48043

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Hope Tower at Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation-Baton Rouge

    New Orleans, Louisiana, 70121

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • New York University Langone Health

    New York, New York, 10016

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Valleywise Health Medical Center

    Phoenix, Arizona, 85008

  • Dignity Health-St Josephs

    Phoenix, Arizona, 85013

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Texas Health Frisco

    Plano, Texas, 75024

  • Maine Medical Center/Maine Medical Partners Adult Hospital Medicine

    Portland, Maine, 04102

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • MultiCare Institute for Research & Innovation

    Puyallup, Washington, 98372

  • Wake Med Hospital

    Raleigh, North Carolina, 27610

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • Renown Health

    Reno, Nevada, 89502

  • UW Medicine Valley Medical Center

    Renton, Washington, 98055

  • Reid Physician Associates

    Richmond, Indiana, 47374

  • Pen Bay Medical Center

    Rockport, Maine, 04856

  • Adventist HealthCare Shady Grove Medical Center

    Rockville, Maryland, 20850

  • Baylor Scott and White-Round Rock

    Round Rock, Texas, 78665

  • UCSF at Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

  • Christus St. Vincent Regional Medical Center

    Santa Fe, New Mexico, 87505

  • Savannah Health Services, LLC DBA Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Willis-Knighton Physician Network/Tri-State Medical Clinic

    Shreveport, Louisiana, 71103

  • New Ananda Medical and Urgent Care, Inc.

    South El Monte, California, 91733

  • Baystate Medical center

    Springfield, Massachusetts, 01199

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • St Louis University

    St Louis, Missouri, 63110

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Tallahassee Memorial HealthCare

    Tallahassee, Florida, 32308

  • James A. Haley Veteran's Hospital

    Tampa, Florida, 33612

  • Baylor Scott and White-Temple

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • The Woodlands Center For Respiratory & Sleep Research

    The Woodlands, Texas, 77380

  • Mazur and Statner MD PC

    Thousand Oaks, California, 91360

  • Torrance Medical Center

    Torrance, California, 90502

  • Capital Health System, Inc.

    Trenton, New Jersey, 08638

  • Ascension St. John Bartlesville

    Tulsa, Oklahoma, 74104

  • Ascension St. John Tulsa

    Tulsa, Oklahoma, 74104

  • CHRISTUS Trinity Clinic Pulmonary Medicine

    Tyler, Texas, 75701

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

  • UT Health East Texas (Tyler)

    Tyler, Texas, 75708

  • Westchester Medical Center

    Valhalla, New York, 10595

  • UT Rio Grande Valley

    Weslaco, Texas, 78596

  • Tower Health Medical Group

    West Reading, Pennsylvania, 19611

  • St. Anthony North Health Campus

    Westminster, Colorado, 80023

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • BayCare Hospital- Winter Haven

    Winter Haven, Florida, 33881

Other trials in United States

About this study

Official title: COVID-19 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge

A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

Read the detailed description

This study is an adaptive, prospective, randomized platform trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. For Stage 1 of this study, participants will be randomized to either prophylactic anticoagulation or matching placebo for 30 days, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, 90 days).

The primary objective is to determine the most effective and safe antithrombotic strategy to prevent the composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days following discharge from the hospital.

Biobanking of samples for future biomarker and mechanistic studies will be available for centers able to participate and collect samples from eligible participants. Samples will be collected at the time of enrollment and after the completion of 30 days of therapy

Conditions
Covid19
Being tested
Apixaban 2.5 MG, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apixaban 2.5 MGDrug

    Also called Eliquis

    Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.

  • PlaceboDrug

    Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.

Study groups in NCT04650087
Study groupRoleWhat they receive
ApixabanActive comparatorDrug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Receives: Drug: Apixaban 2.5 MG
PlaceboPlacebo comparatorDrug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.

    Composite endpoint (CE) of venous and arterial thrombotic complications-including new, symptomatic proximal, or distal DVT of the upper or lower extremities, PE, and new thrombosis of other veins (including cerebral sinus and splanchnic veins), ischemic stroke, myocardial infarction, other arterial thromboembolism (e.g., mesenteric or acute limb ischemia), and all-cause mortality by day 30.

    Measured: 30 days after hospital discharge

Secondary outcomes (6)

  1. The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score.

    Composite endpoint of mortality and EQ5D index at Day 30. All mortality events will be considered worse than any possible EQ5D response [QOL\&M30]. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.

    Measured: 30 days after hospital discharge

  2. The Composite Outcome of All-cause Mortality and the EQ5D Index Score.

    Composite endpoint of mortality and EQ5D index at Day 90. All mortality events will be considered worse than any possible EQ5D response. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.

    Measured: 90 days after hospital discharge

  3. The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.

    Measured: 45 days after hospital discharge

  4. The Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records.

    Measured: 90 days after hospital discharge

  5. New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records.

    Measured: 30 days after randomization (which occurred at time of hospital discharge)

  6. New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records.

    Measured: 30 days after randomization (which occurred at time of hospital discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2020
  2. Study start15 Feb 2021
  3. Primary completion24 Jul 2022
  4. Study completion23 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04650087
Sponsor's protocol ID
Pro00107078
Status last verified
Feb 2025
First submitted
30 Nov 2020
Last updated
25 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37591523

  • Wang TY, Wahed AS, Morris A, Kreuziger LB, Quigley JG, Lamas GA, Weissman AJ, Lopez-Sendon J, Knudson MM, Siegal DM, Kasthuri RS, Alexander AJ, Wahid L, Atassi B, Miller PJ, Lawson JW, Patel B, Krishnan JA, Shapiro NL, Martin DE, Kindzelski AL, Leifer ES, Joo J, Lyu L, Pennella A, Everett BM, Geraci MW, Anstrom KJ, Ortel TL; ACTIV-4C Study Group. Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization. Ann Intern Med. 2023 Apr;176(4):515-523. doi: 10.7326/M22-3350. Epub 2023 Mar 21.

    PubMed 36940444

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban 2.5 MG in people with Covid19, run by Thomas L. Ortel at 121 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Outcome of Symptomatic Deep Vein Thrombosis, Pulmonary Embolism, Other Venous Thromboembolism, Ischemic Stroke, Myocardial Infarction, Other Arterial Thromboembolism, and All-cause Mortality as Measured by Hospital Records. (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04650087, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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