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Can an arthritis drug speed COVID-19 recovery? new trial tests abatacept

NCT ID NCT05822583

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tested whether the immune-modulating drug abatacept, given early to hospitalized COVID-19 patients on low-flow oxygen, helps them recover faster compared to a placebo. A total of 285 adults participated. The goal was to see if adding abatacept to standard care improves outcomes like time to recovery and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abatacept
What this could lead to
If successful, this could point toward a treatment that speeds recovery for hospitalized COVID-19 patients on low-flow oxygen.
What could go wrong
This is a completed phase 4 trial, but results are not yet widely published. The benefit may be modest or not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

285 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test \[list of approved tests in the PIM\] within 14 days of randomization. * Requiring hospitalization for the management of COVID-19 * Has evidence of COVID-19 pneumonia (PNA) defined as either receiving supplementary oxygen ≤2L of low flow oxygen with evidence of airspace disease on chest imaging (X ray, computer tomography or ultrasound) OR receiving supplementary oxygen \&gt;2L and \&lt;10 L of low flow oxygen. * Currently receiving or planned to receive (ordered) one IM drug (for example, a corticosteroid or baricitinib) as part of treatment of COVID-19 prior to randomization. * Has started supplemental oxygen for the treatment of COVID-19 within the past 5 calendar days. Patients on home oxygen are eligible if current oxygen flow rate is increased from baseline and other above criteria are met. * Investigator agrees that the pneumonia is due to COVID-19. Exclusion Criteria: * Oxygen requirement of ≥10L or more of low flow oxygen (or equivalent if using Venturi mask, etc), or requiring either HFNO, NIV, IMV, or ECMO. * Participant has received more than one baseline IM for treatment of the current COVID-19 infection at time of trial enrollment. (Examples: corticosteroid, baricitinib, tocilizumab, anakinra, abatacept, or infliximab.) * Participant anticipated to not meet all inclusion criteria within 24 hours of randomization in the opinion of the investigator. * Allergy to investigational agent. * Neutropenia (absolute neutrophil count \<1000 cells/μL) (\<1.0 x 10 3 /μL or \<1.0 G/L) on most recent lab within 2 calendar days of randomization. * Lymphopenia (absolute lymphocyte count \<200 cells/μL) (\<0.20 x 10 3 /μL or \<0.20 G/L) on most recent lab within 2 calendar days of randomization. * Known or suspected active or recent serious infection (bacterial, fungal, viral, or parasitic infection, excepting SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking investigational agent. Note: Broad spectrum empiric antibiotic usage does not exclude participation. * Known or suspected history of untreated tuberculosis (TB). TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection. Participants are also excluded if they have known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required). * Have received any live vaccine (or live attenuated) within 3 months before screening or intend to receive a live vaccine (or live attenuated) during the trial. Use of prior non-live (inactivated) vaccinations is allowed for all participants, including any vaccine for COVID-19. * Pre-existing immunomodulation or immunosuppression that meets any of the following: Participant has received abatacept for an indication other than COVID- 19 within 5 half-lives (65 days) of enrollment (Abatacept elimination half-life is 13.1 days.) Participant is receiving immune modulatory therapy for autoimmune, transplant management or another indication AND has one or more of the following: evidence of active infection (other than COVID-19) or has required reduction in their immune modulatory therapy in the preceding 6 months due to infectious complication (routine reduction as SOC is not an exclusion) or has required intensification in immunotherapy within the preceding 6 months due to organ rejection/worsening underlying disease status (e.g., intensification with an additional agent on top of usual immunosuppressive regimen) * Participant has recently received or is anticipated to require immune modulatory agents for their underlying disease including chemotherapeutic treatments likely to induce neutropenia (\&lt;1.0 x 10 9 cells/µL) or lymphopenia (\&lt;1.0 x 10 9 cells/µL) * Participant has untreated advanced HIV (known CD4 \&lt;200 in the past 6 months) AND is not established on antiretroviral therapy * Pregnancy * Breastfeeding * Co-enrollment in other trials not predetermined to be compatible with this trial. * In the investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate. * The treating clinician expects inability to participate in trial procedures or participation would not be in the best interests of the patient.

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19

Contacts and locations

Locations

  • 1st Respiratory Medicine Department, Athens University Medical School (635-015)

    Athens, Attica, 11527, Greece

  • 3rd Dept of Medicine, Medical School, NKUA (635-022)

    Athens, Attica, 11527, Greece

  • AIDS and Clinical Immunology Research Center (627-201)

    Tbilisi, 0159, Georgia

  • Aalborg Hospital (Site 625-005)

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital, Skejby (Site 625-002)

    Aarhus, 8200, Denmark

  • Asan Medical Center (612-901)

    Seoul, 05505, South Korea

  • Attikon University General Hospital (Site 635-009)

    Athens, Attica, 12462, Greece

  • Austin Health (612-020)

    Heidelberg, Victoria, 3084, Australia

  • Banner University Medical Center Tucson (Site 206-004)

    Tucson, Arizona, 85719, United States

  • Baylor, Scott and White Health (301-003)

    Dallas, Texas, 75246, United States

  • Baystate Medical Center (Site 201-001)

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess Medical Center (202-001)

    Boston, Massachusetts, 02215, United States

  • Bispebjerg Hospital (Site 625-013)

    Copenhagen, 2400, Denmark

  • CHRISTUS Spohn Shoreline Hospital (080-001)

    Corpus Christi, Texas, 78404, United States

  • Cedars-Sinai Medical Center (208-002)

    Los Angeles, California, 90048, United States

  • Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302)

    Ivano-Frankivsk, 76018, Ukraine

  • Chennai Antiviral Research and Treatment Clinical Research Site (Site 612-402)

    Chennai, Tamil Nadu, 600113, India

  • Chulalongkorn University and The HIV-NAT (Site 613-001)

    Bangkok, 10330, Thailand

  • Chung-Ang University Hospital (612-902)

    Seoul, 06973, South Korea

  • Cleveland Clinic Foundation (Site 207-001)

    Cleveland, Ohio, 44195, United States

  • Cooper University Hospital (019-001)

    Camden, New Jersey, 08103, United States

  • Dartmouth-Hitchcock Medical Center (301-024)

    Lebanon, New Hampshire, 03756, United States

  • Democritus University of Thrace (635-021)

    Alexandroupoli, Evros, 68131, Greece

  • Duke University Hospital (Site 301-006)

    Durham, North Carolina, 27710, United States

  • Emory Grady (Site 301-032)

    Atlanta, Georgia, 30303, United States

  • Froedtert Memorial Lutheran Hospital (052-001)

    Milwaukee, Wisconsin, 53226, United States

  • Harborview Medical Center (208-001)

    Seattle, Washington, 98104, United States

  • Hendrick Medical Center (Site 080-014)

    Abilene, Texas, 79602, United States

  • Henry Ford Health System (014-001)

    Detroit, Michigan, 48202, United States

  • Herlev/Gentofte Hospital (Site 625-012

    Hellerup, 2900, Denmark

  • Hope Clinic, Emory University (Site 301-031)

    Decatur, Georgia, 30030, United States

  • Hospital #1 of Zhytomyr City Council (627-303)

    Zhytomyr, 10002, Ukraine

  • Hospital Clinic de Barcelona (626-004)

    Barcelona, 08036, Spain

  • Hospital Universitari Germans Trias i Pujol (626-003)

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Vall d'Hebron (626-033)

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz (Site 626-012)

    Madrid, 28046, Spain

  • Hospital del Mar (626-025)

    Barcelona, 08003, Spain

  • Houston Methodist Research Institute (Site 301-028)

    Houston, Texas, 77030, United States

  • Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001)

    Hvidovre, 2650, Denmark

  • Hôpital Saint André (Site 631-041)

    Bordeaux, 33000, France

  • Institute of Human Virology-Nigeria (IHVN) (612-601)

    Abuja, Federal Capital Territory, Nigeria

  • Intermountain Medical Center (Site 211-001)

    Murray, Utah, 84107, United States

  • James J. Peters VAMC (Site 023-003)

    The Bronx, New York, 10468, United States

  • Karolinska University Hospital, Solna (Site 625-206)

    Stockholm, 171 76, Sweden

  • Khon Kaen University, Srinagarind Hospital (613-003)

    Khon Kaen, 40002, Thailand

  • Klinik I für Innere Medizin der Universität zu Köln (622-008)

    Cologne, 50937, Germany

  • Lahey Hospital and Medical Center (Site 213-001)

    Burlington, Massachusetts, 01805, United States

  • Lincoln Medical Center (Site 003-016)

    The Bronx, New York, 10451, United States

  • Lutheran Medical Group (301-010)

    Fort Wayne, Indiana, 46804, United States

  • M Health Fairview University of Minnesota Medical Center (112-001)

    Minneapolis, Minnesota, 55455, United States

  • Massachusetts General Hospital (202-002)

    Boston, Massachusetts, 02114, United States

  • MedStar Health Research Institute (Site 009-021)

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina (Site 210-002)

    Charleston, South Carolina, 29425, United States

  • MemorialCare Health System (066-003)

    Long Beach, California, 90806, United States

  • Monash Health (612-009)

    Clayton, Victoria, 3168, Australia

  • Mount Sinai Medical Center (Site 301-012)

    New York, New York, 11234, United States

  • NYC Health + Hospital Harlem (Site 003-003)

    New York, New York, 10037, United States

  • NYU Brooklyn (301-033)

    Brooklyn, New York, 11220, United States

  • NYU Long Island (301-034)

    Mineola, New York, 11501, United States

  • National Medical Center (612-905)

    Seoul, 04564, South Korea

  • New Jersey Medical School Clinical Research Center (028-001)

    Newark, New Jersey, 07103, United States

  • New York Presbyterian Queens (003-005)

    Flushing, New York, 11355, United States

  • New York University Langone Health (301-013)

    New York, New York, 10016, United States

  • Nordsjællands Hospital, Hillerød (Site 625-009)

    Hillerød, 3400, Denmark

  • Odense University Hospital (625-004)

    Odense, C, 5000, Denmark

  • Oregon Health and Science University (208-003)

    Portland, Oregon, 97239, United States

  • Parkland Health and Hospital Systems (084-002)

    Dallas, Texas, 75235, United States

  • Penn State Health Milton S. Hershey Medical Center (Site 209-002)

    Hershey, Pennsylvania, 17033, United States

  • Providence (Sacred Heart) (213-004)

    Spokane, Washington, 99204, United States

  • Public Health Institute at Denver Health (Site 017-004)

    Denver, Colorado, 80204, United States

  • Ralph H. Johnson VA Medical Center (074-015)

    Charleston, South Carolina, 29401, United States

  • Rhode Island Hospital (Site 080-036)

    Providence, Rhode Island, 02903, United States

  • Rigshospitalet, CHIP (Site 625-006)

    Copenhagen, 2100, Denmark

  • Rocky Mountain Regional VA Medical Center (Site 074-010)

    Aurora, Colorado, 80045, United States

  • Ronald Reagan UCLA Medical Center (Site 203-002)

    Los Angeles, California, 90095, United States

  • Royal Brisbane and Women's Hospital (612-055)

    Brisbane, Queensland, 4029, Australia

  • Salem VA Medical Center (Site 074-014)

    Salem, Virginia, 24153, United States

  • San Francisco VAMC (Site 074-002)

    San Francisco, California, 94121, United States

  • Seoul National University Bundang Hospital (612-904)

    Seongnam, 13620, South Korea

  • Seoul St. Mary's Hospital (Site 612-903)

    Seoul, 06591, South Korea

  • Sinai-Grace Hospital (Site 205-005)

    Detroit, Michigan, 48235, United States

  • Siriraj Hospital (613-002)

    Bangkok Noi, Bangkok, 10700, Thailand

  • Southern Arizona VA Healthcare System (Site 074-009)

    Tucson, Arizona, 85723, United States

  • St Vincent's University Hospital (Site 634-103)

    Dublin, D04 T6F4, Ireland

  • St. Vincent's Hospital (Site 612-002)

    Sydney, New South Wales, 2010, Australia

  • Stanford University Hospital & Clinics (Site 203-003)

    Stanford, California, 94305, United States

  • Tampa General Hospital (032-001)

    Tampa, Florida, 33606, United States

  • Tan Tock Seng Hospital (Site 612-201)

    Singapore, 308433, Singapore

  • The Alfred Hospital (612-017)

    Melbourne, Victoria, 3004, Australia

  • The Miriam Hospital (Site 080-039)

    Providence, Rhode Island, 02906, United States

  • Treatment and Diagnostic Center ADONIS Plus (627-304)

    Kyiv, 02002, Ukraine

  • UC Davis Health (Site 203-004)

    Davis, California, 95616, United States

  • UCSF Fresno (Site 203-005)

    Fresno, California, 93721, United States

  • UCSF Medical Center (Site 203-001)

    San Francisco, California, 94143, United States

  • UCSF Medical Center at Mount Zion (203-007)

    San Francisco, California, 94115, United States

  • UT Health San Antonio (Site 009-022)

    San Antonio, Texas, 78229, United States

  • UT Southwestern Medical Center (084-001)

    Dallas, Texas, 75390, United States

  • University Hospital Basel (636-004)

    Basel, 4031, Switzerland

  • University Hospital Plymouth NHS Trust (Site 634-014)

    Plymouth, Devon, PL6 8DH, United Kingdom

  • University of Alabama Birmingham University Hospital (Site 213-002)

    Birmingham, Alabama, 35233, United States

  • University of Colorado Hospital (Site 204-001)

    Aurora, Colorado, 80045, United States

  • University of Illinois at Chicago (008-012)

    Chicago, Illinois, 60612, United States

  • University of Kansas Medical Center (Site 080-044)

    Kansas City, Kansas, 66160, United States

  • University of Massachusetts Chan Medical School (080-007)

    Worcester, Massachusetts, 01655, United States

  • University of Michigan Medical Center (205-001)

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center (Site 202-005)

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center (Site 080-045)

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Hospital (Site 213-008)

    Albuquerque, New Mexico, 87106, United States

  • University of Texas Health Science Center (Site 203-006)

    Houston, Texas, 77030, United States

  • University of Utah Hospital (211-002)

    Salt Lake City, Utah, 84108, United States

  • VA Ann Arbor Healthcare System (Site 074-028)

    Ann Arbor, Michigan, 48105, United States

  • VA Loma Linda Healthcare System (074-017)

    Loma Linda, California, 92357, United States

  • VA Long Beach Healthcare System (074-026)

    Long Beach, California, 90822, United States

  • VA Northern California Health Care System (Site 074-023)

    Mather, California, 95655, United States

  • VA San Diego Healthcare System (074-016)

    San Diego, California, 92161, United States

  • Vanderbilt University Medical Center (Site 212-001)

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Health (Site 210-001)

    Winston-Salem, North Carolina, 27157, United States

  • Washington DC VA Medical Center (Site 009-004)

    Washington D.C., District of Columbia, 20422, United States

  • Washington University School of Medicine (Site 003-001)

    St Louis, Missouri, 63310, United States

  • Weill Cornell Clinical Research Unit (065-001)

    New York, New York, 10065, United States

  • West Virginia University Medicine (Site 301-023)

    Morgantown, West Virginia, 26506, United States

  • Westmead Hospital (Site 612-058)

    Westmead, New South Wales, 2145, Australia

  • William S. Middleton Memorial Veterans Hospital (074-030)

    Madison, Wisconsin, 53705, United States

  • Wojewodzki Szpital Zakazny (Site 625-302)

    Warsaw, 01-201, Poland

  • Yale University (Site 025-001)

    New Haven, Connecticut, 06510, United States

  • Zuckerberg San Francisco General Hospital and Trauma Center (213-007)

    San Francisco, California, 94110, United States

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