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COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment group | Experimental | Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM |
|
| Control group | Placebo Comparator | Placebo group (IV infusion of normal saline) + baseline IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abatacept infusion | Drug | The dose of abatacept will be 10 mg/kg given as a single infusion on Day 0, with a maximum dose of 1,750 mg, so any participant with weight of >175 kg will receive a dose of 1750 mg. + baseline IM (immune modulator) |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Recovery Scale | DRS-60 is a version of the STRIVE clinical recovery scale (CRS) which combines time to recovery with non-recovered clinical state and death to an ordinal outcome.0 indicates best results, 60 represents recovered on Day 60, with not recovered by Day 60 coded as 61 and death (worst outcome) as 62. | 60 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| time to sustained recovery though Day 60 | Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to the end of follow-up | baseline to day 60 |
| all-cause mortality though Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cavan Reilly, PhD | University of Minnesota | Principal Investigator |
| Christina Barkauskas, MD | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham University Hospital (Site 213-002) | Birmingham | Alabama | 35233 | United States | ||
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| Placebo group | Drug | Placebo group (IV infusion of normal saline) + baseline IM |
|
substantial attempts will be made to determine vital status through the end of follow-up by a combined approach of follow-up visits with the participant or proxy, chart review, and review of other available information sources. |
| baseline to day 60 |
| time to progression | will be defined by the study day on which a participant experiences a definite progression. Definite progression is defined as a participant requiring HFNO, NIV, IMV, or ECMO therapy, OR, if HFNO is unavailable, a participant requiring ≥15 L/min conventional oxygen. Probable progression is defined as a participant not meeting criteria for definite progression but requiring ≥10 L/min conventional oxygen, OR, a participant with an oxygen requirement that has increased by ≥4 L/min in the preceding 24 hours. | baseline to day 60 |
| Three-category ordinal outcome | assessed at Day 60, with categories "recovered (alive and at home at Day 60)", "alive and not recovered", and dead | Day 60 |
| the pulmonary ordinal outcome | categories defined as:
| Day 5, 14, and 28 |
| Banner University Medical Center Tucson (Site 206-004) |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Southern Arizona VA Healthcare System (Site 074-009) | Tucson | Arizona | 85723 | United States |
| UC Davis Health (Site 203-004) | Davis | California | 95616 | United States |
| UCSF Fresno (Site 203-005) | Fresno | California | 93721 | United States |
| VA Loma Linda Healthcare System (074-017) | Loma Linda | California | 92357 | United States |
| MemorialCare Health System (066-003) | Long Beach | California | 90806 | United States |
| VA Long Beach Healthcare System (074-026) | Long Beach | California | 90822 | United States |
| Cedars-Sinai Medical Center (208-002) | Los Angeles | California | 90048 | United States |
| Ronald Reagan UCLA Medical Center (Site 203-002) | Los Angeles | California | 90095 | 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 |
| Zuckerberg San Francisco General Hospital and Trauma Center (213-007) | San Francisco | California | 94110 | United States |
| UCSF Medical Center at Mount Zion (203-007) | San Francisco | California | 94115 | United States |
| San Francisco VAMC (Site 074-002) | San Francisco | California | 94121 | United States |
| UCSF Medical Center (Site 203-001) | San Francisco | California | 94143 | United States |
| Stanford University Hospital & Clinics (Site 203-003) | Stanford | California | 94305 | United States |
| Rocky Mountain Regional VA Medical Center (Site 074-010) | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital (Site 204-001) | Aurora | Colorado | 80045 | United States |
| Public Health Institute at Denver Health (Site 017-004) | Denver | Colorado | 80204 | United States |
| Yale University (Site 025-001) | New Haven | Connecticut | 06510 | United States |
| MedStar Health Research Institute (Site 009-021) | Washington D.C. | District of Columbia | 20010 | United States |
| Washington DC VA Medical Center (Site 009-004) | Washington D.C. | District of Columbia | 20422 | United States |
| Tampa General Hospital (032-001) | Tampa | Florida | 33606 | United States |
| Emory Grady (Site 301-032) | Atlanta | Georgia | 30303 | United States |
| Hope Clinic, Emory University (Site 301-031) | Decatur | Georgia | 30030 | United States |
| University of Illinois at Chicago (008-012) | Chicago | Illinois | 60612 | United States |
| Lutheran Medical Group (301-010) | Fort Wayne | Indiana | 46804 | United States |
| University of Kansas Medical Center (Site 080-044) | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital (202-002) | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center (202-001) | Boston | Massachusetts | 02215 | United States |
| Lahey Hospital and Medical Center (Site 213-001) | Burlington | Massachusetts | 01805 | United States |
| Baystate Medical Center (Site 201-001) | Springfield | Massachusetts | 01199 | United States |
| University of Massachusetts Chan Medical School (080-007) | Worcester | Massachusetts | 01655 | United States |
| VA Ann Arbor Healthcare System (Site 074-028) | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan Medical Center (205-001) | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System (014-001) | Detroit | Michigan | 48202 | United States |
| Sinai-Grace Hospital (Site 205-005) | Detroit | Michigan | 48235 | United States |
| M Health Fairview University of Minnesota Medical Center (112-001) | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center (Site 202-005) | Jackson | Mississippi | 39216 | United States |
| Washington University School of Medicine (Site 003-001) | St Louis | Missouri | 63310 | United States |
| University of Nebraska Medical Center (Site 080-045) | Omaha | Nebraska | 68198 | United States |
| Dartmouth-Hitchcock Medical Center (301-024) | Lebanon | New Hampshire | 03756 | United States |
| Cooper University Hospital (019-001) | Camden | New Jersey | 08103 | United States |
| New Jersey Medical School Clinical Research Center (028-001) | Newark | New Jersey | 07103 | United States |
| University of New Mexico Hospital (Site 213-008) | Albuquerque | New Mexico | 87106 | United States |
| NYU Brooklyn (301-033) | Brooklyn | New York | 11220 | United States |
| New York Presbyterian Queens (003-005) | Flushing | New York | 11355 | United States |
| NYU Long Island (301-034) | Mineola | New York | 11501 | United States |
| New York University Langone Health (301-013) | New York | New York | 10016 | United States |
| NYC Health + Hospital Harlem (Site 003-003) | New York | New York | 10037 | United States |
| Weill Cornell Clinical Research Unit (065-001) | New York | New York | 10065 | United States |
| Mount Sinai Medical Center (Site 301-012) | New York | New York | 11234 | United States |
| Lincoln Medical Center (Site 003-016) | The Bronx | New York | 10451 | United States |
| James J. Peters VAMC (Site 023-003) | The Bronx | New York | 10468 | United States |
| Duke University Hospital (Site 301-006) | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Health (Site 210-001) | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic Foundation (Site 207-001) | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University (208-003) | Portland | Oregon | 97239 | United States |
| Penn State Health Milton S. Hershey Medical Center (Site 209-002) | Hershey | Pennsylvania | 17033 | United States |
| Rhode Island Hospital (Site 080-036) | Providence | Rhode Island | 02903 | United States |
| The Miriam Hospital (Site 080-039) | Providence | Rhode Island | 02906 | United States |
| Ralph H. Johnson VA Medical Center (074-015) | Charleston | South Carolina | 29401 | United States |
| Medical University of South Carolina (Site 210-002) | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center (Site 212-001) | Nashville | Tennessee | 37232 | United States |
| Hendrick Medical Center (Site 080-014) | Abilene | Texas | 79602 | United States |
| CHRISTUS Spohn Shoreline Hospital (080-001) | Corpus Christi | Texas | 78404 | United States |
| Parkland Health and Hospital Systems (084-002) | Dallas | Texas | 75235 | United States |
| Baylor, Scott and White Health (301-003) | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center (084-001) | Dallas | Texas | 75390 | United States |
| Houston Methodist Research Institute (Site 301-028) | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center (Site 203-006) | Houston | Texas | 77030 | United States |
| UT Health San Antonio (Site 009-022) | San Antonio | Texas | 78229 | United States |
| Intermountain Medical Center (Site 211-001) | Murray | Utah | 84107 | United States |
| University of Utah Hospital (211-002) | Salt Lake City | Utah | 84108 | United States |
| Salem VA Medical Center (Site 074-014) | Salem | Virginia | 24153 | United States |
| Harborview Medical Center (208-001) | Seattle | Washington | 98104 | United States |
| Providence (Sacred Heart) (213-004) | Spokane | Washington | 99204 | United States |
| West Virginia University Medicine (Site 301-023) | Morgantown | West Virginia | 26506 | United States |
| William S. Middleton Memorial Veterans Hospital (074-030) | Madison | Wisconsin | 53705 | United States |
| Froedtert Memorial Lutheran Hospital (052-001) | Milwaukee | Wisconsin | 53226 | United States |
| St. Vincent's Hospital (Site 612-002) | Sydney | New South Wales | 2010 | Australia |
| Westmead Hospital (Site 612-058) | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital (612-055) | Brisbane | Queensland | 4029 | Australia |
| Monash Health (612-009) | Clayton | Victoria | 3168 | Australia |
| Austin Health (612-020) | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital (612-017) | Melbourne | Victoria | 3004 | Australia |
| Odense University Hospital (625-004) | Odense | C | 5000 | Denmark |
| Aalborg Hospital (Site 625-005) | Aalborg | 9000 | Denmark |
| Aarhus Universitetshospital, Skejby (Site 625-002) | Aarhus | 8200 | Denmark |
| Rigshospitalet, CHIP (Site 625-006) | Copenhagen | 2100 | Denmark |
| Bispebjerg Hospital (Site 625-013) | Copenhagen | 2400 | Denmark |
| Herlev/Gentofte Hospital (Site 625-012 | Hellerup | 2900 | Denmark |
| Nordsjællands Hospital, Hillerød (Site 625-009) | Hillerød | 3400 | Denmark |
| Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001) | Hvidovre | 2650 | Denmark |
| Hôpital Saint André (Site 631-041) | Bordeaux | 33000 | France |
| AIDS and Clinical Immunology Research Center (627-201) | Tbilisi | 0159 | Georgia |
| Klinik I für Innere Medizin der Universität zu Köln (622-008) | Cologne | 50937 | Germany |
| 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 |
| Attikon University General Hospital (Site 635-009) | Athens | Attica | 12462 | Greece |
| Democritus University of Thrace (635-021) | Alexandroupoli | Evros | 68131 | Greece |
| Chennai Antiviral Research and Treatment Clinical Research Site (Site 612-402) | Chennai | Tamil Nadu | 600113 | India |
| St Vincent's University Hospital (Site 634-103) | Dublin | D04 T6F4 | Ireland |
| Institute of Human Virology-Nigeria (IHVN) (612-601) | Abuja | Federal Capital Territory | Nigeria |
| Wojewodzki Szpital Zakazny (Site 625-302) | Warsaw | 01-201 | Poland |
| Tan Tock Seng Hospital (Site 612-201) | Singapore | 308433 | Singapore |
| Seoul National University Bundang Hospital (612-904) | Seongnam | 13620 | South Korea |
| National Medical Center (612-905) | Seoul | 04564 | South Korea |
| Asan Medical Center (612-901) | Seoul | 05505 | South Korea |
| Seoul St. Mary's Hospital (Site 612-903) | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital (612-902) | Seoul | 06973 | South Korea |
| Hospital Universitari Germans Trias i Pujol (626-003) | Badalona | Barcelona | 08916 | Spain |
| Hospital del Mar (626-025) | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebron (626-033) | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona (626-004) | Barcelona | 08036 | Spain |
| Hospital Universitario La Paz (Site 626-012) | Madrid | 28046 | Spain |
| Karolinska University Hospital, Solna (Site 625-206) | Stockholm | 171 76 | Sweden |
| University Hospital Basel (636-004) | Basel | 4031 | Switzerland |
| Siriraj Hospital (613-002) | Bangkok Noi | Bangkok | 10700 | Thailand |
| Chulalongkorn University and The HIV-NAT (Site 613-001) | Bangkok | 10330 | Thailand |
| Khon Kaen University, Srinagarind Hospital (613-003) | Khon Kaen | 40002 | Thailand |
| Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302) | Ivano-Frankivsk | 76018 | Ukraine |
| Treatment and Diagnostic Center ADONIS Plus (627-304) | Kyiv | 02002 | Ukraine |
| Hospital #1 of Zhytomyr City Council (627-303) | Zhytomyr | 10002 | Ukraine |
| University Hospital Plymouth NHS Trust (Site 634-014) | Plymouth | Devon | PL6 8DH | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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