Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 >2L and <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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
active treatment group
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM
  • Drug: abatacept infusion
    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)
Placebo Comparator
Control group
Placebo group (IV infusion of normal saline) + baseline IM
  • Drug: Placebo group
    Placebo group (IV infusion of normal saline) + baseline IM

Recruiting Locations

University of Alabama Birmingham University Hospital (Site 213-002)
Birmingham, Alabama 35233
Contact:
Nashville ICC
strivenash@insight-trials.org

Banner University Medical Center Tucson (Site 206-004)
Tucson, Arizona 85719
Contact:
Nashville ICC
strivenash@insight-trials.org

Southern Arizona VA Healthcare System (Site 074-009)
Tucson, Arizona 85723
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

UC Davis Health (Site 203-004)
Davis, California 95616
Contact:
Nashville ICC
strivenash@insight-trials.org

UCSF Fresno (Site 203-005)
Fresno, California 93721
Contact:
Nashville ICC
strivenash@insight-trials.com

VA Loma Linda Healthcare System (074-017)
Loma Linda, California 92357
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

VA Long Beach Healthcare System (074-026)
Long Beach, California 90822
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

Ronald Reagan UCLA Medical Center (Site 203-002)
Los Angeles, California 90095
Contact:
Nashville ICC
strivenash@insight-trials.org

VA San Diego Healthcare System (074-016)
San Diego, California 92161
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

Zuckerberg San Francisco General Hospital and Trauma Center (213-007)
San Francisco, California 94110
Contact:
Nashville ICC
strivenash@insight-trials.org

UCSF Medical Center at Mount Zion (203-007)
San Francisco, California 94115
Contact:
Nashville ICC
strivenash@insight-trials.org

San Francisco VAMC (Site 074-002)
San Francisco, California 94121
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

UCSF Medical Center (Site 203-001)
San Francisco, California 94143
Contact:
Nashville ICC
strivenash@insight-trials.org

Stanford University Hospital & Clinics (Site 203-003)
Stanford, California 94305
Contact:
Nashville ICC
strivenash@insight-trials.org

Rocky Mountain Regional VA Medical Center (Site 074-010)
Aurora, Colorado 80045
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

University of Colorado Hospital (Site 204-001)
Aurora, Colorado 80045
Contact:
Nashville ICC
strivenash@insight-trials.org

Public Health Institute at Denver Health (Site 017-004)
Denver, Colorado 80204
Contact:
Washington ICC
strivewdc@insight-trials.org

MedStar Health Research Institute (Site 009-021)
Washington, District of Columbia 20010
Contact:
Washington ICC
strivewdc@insight-trials.org

Washington DC VA Medical Center (Site 009-004)
Washington, District of Columbia 20422
Contact:
Washington ICC
strivewdc@insighttrials.org

Emory Grady (Site 301-032)
Atlanta, Georgia 30303
Contact:
New York ICC
striveny@insight-trials.org

Hope Clinic, Emory University (Site 301-031)
Decatur, Georgia 30030
Contact:
New York ICC
striveny@insight-trials.org

Lutheran Medical Group (301-010)
Fort Wayne, Indiana 46804
Contact:
NY ICC
striveny@insight-trials.org

University of Kansas Medical Center (Site 080-044)
Kansas City, Kansas 66160
Contact:
Hennepin ICC
strivehenn@insight-trials.org

Lahey Hospital and Medical Center (Site 213-001)
Burlington, Massachusetts 01805
Contact:
Nashville ICC
strivenash@insight-trials.org

Baystate Medical Center (Site 201-001)
Springfield, Massachusetts 01199
Contact:
Nashville ICC ICC
strivenash@insight-trials.org

VA Ann Arbor Healthcare System (Site 074-028)
Ann Arbor, Michigan 48105
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

Henry Ford Health System (014-001)
Detroit, Michigan 48202
Contact:
Washington ICC
strivewdc@insight-trials.org

Sinai-Grace Hospital (Site 205-005)
Detroit, Michigan 48235
Contact:
Nashville ICC
strivenash@insight-trials.org

M Health Fairview University of Minnesota Medical Center (112-001)
Minneapolis, Minnesota 55455
Contact:
Hennepin ICC
strivehenn@insight-trials.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Rebecca Schoenecker, MPH
sitereg@insight-trials.org

University of Mississippi Medical Center (Site 202-005)
Jackson, Mississippi 39216
Contact:
Nashville ICC
strivenash@insight-trials.org

Washington University School of Medicine (Site 003-001)
Saint Louis, Missouri 63310
Contact:
Washington ICC
strivewdc@insight-trials.org

University of Nebraska Medical Center (Site 080-045)
Omaha, Nebraska 68198
Contact:
Hennepin ICC
strivehenn@insight-trials.org

Dartmouth-Hitchcock Medical Center (301-024)
Lebanon, New Hampshire 03756
Contact:
NY ICC
striveny@insight-trials.org

Cooper University Hospital (019-001)
Camden, New Jersey 08103
Contact:
Washington ICC
strivewdc@insight-trials.org

University of New Mexico Hospital (Site 213-008)
Albuquerque, New Mexico 87106
Contact:
Nashville ICC
strivenash@insight-trials.org

NYU Brooklyn (301-033)
Brooklyn, New York 11220
Contact:
New York ICC
striveny@insight-trials.org

NYU Long Island (301-034)
Mineola, New York 11501
Contact:
New York ICC
striveny@insight-trials.org

New York University Langone Health (301-013)
New York, New York 10016
Contact:
NY ICC
striveny@insight-trials.org

Weill Cornell Clinical Research Unit (065-001)
New York, New York 10065
Contact:
Washington ICC
strivewdc@insight-trials.org

Mount Sinai Medical Center (Site 301-012)
New York, New York 11234
Contact:
New York ICC
striveny@insight-trials.org

Duke University Hospital (Site 301-006)
Durham, North Carolina 27710
Contact:
New York ICC
striveny@insight-trials.org

Wake Forest Baptist Health (Site 210-001)
Winston-Salem, North Carolina 27157
Contact:
Nashville ICC
strivenash@insight-trials.org

Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio 44195
Contact:
Nashville ICC
strivenash@insight-trials.org

Penn State Health Milton S. Hershey Medical Center (Site 209-002)
Hershey, Pennsylvania 17033
Contact:
Hennepin ICC
strivehenn@insight-trials.org

Rhode Island Hospital (Site 080-036)
Providence, Rhode Island 02903
Contact:
Hennepin ICC
strivehenn@insight-trials.org

The Miriam Hospital (Site 080-039)
Providence, Rhode Island 02906
Contact:
Hennepin ICC
strivehenn@insight-trials.org

Ralph H. Johnson VA Medical Center (074-015)
Charleston, South Carolina 29401
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

Medical University of South Carolina (Site 210-002)
Charleston, South Carolina 29425
Contact:
Nashville ICC
strivenash@insight-trials.org

Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee 37232
Contact:
Nashville ICC
strivenash@insight-trials.org

Hendrick Medical Center (Site 080-014)
Abilene, Texas 79602
Contact:
Hennepin ICC
strivehenn@insight-trials.org

Parkland Health and Hospital Systems (084-002)
Dallas, Texas 75235
Contact:
Washington ICC
strivewdc@insight-trials.org

Baylor, Scott and White Health (301-003)
Dallas, Texas 75246
Contact:
NY ICC
striveny@insight-trials.org

UT Southwestern Medical Center (084-001)
Dallas, Texas 75390
Contact:
Washington ICC
strivewdc@insight-trials.org

Houston Methodist Research Institute (Site 301-028)
Houston, Texas 77030
Contact:
Hennepin ICC
strivehenn@insight-trials.org

University of Texas Health Science Center (Site 203-006)
Houston, Texas 77030
Contact:
Nashville ICC
strivenash@insight-trials.org

Intermountain Medical Center (Site 211-001)
Murray, Utah 84107
Contact:
Nashville ICC
strivenash@insight-trials.org

University of Utah Hospital (211-002)
Salt Lake City, Utah 84108
Contact:
Nashville ICC
strivenash@insight-trials.org

Salem VA Medical Center (Site 074-014)
Salem, Virginia 24153
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

Providence (Sacred Heart) (213-004)
Spokane, Washington 99204
Contact:
Nashville ICC
strivenash@insight-trials.org

West Virginia University Medicine (Site 301-023)
Morgantown, West Virginia 26506
Contact:
New York ICC
striveny@insight-trials.org

William S. Middleton Memorial Veterans Hospital (074-030)
Madison, Wisconsin 53705
Contact:
Veterans Affairs ICC
striveva@insight-trials.org

Froedtert Memorial Lutheran Hospital (052-001)
Milwaukee, Wisconsin 53226
Contact:
Washington ICC
strivewdc@insight-trials.org

More Details

NCT ID
NCT05822583
Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Cavan Reilly, PhD
612-624-9644
webe0376@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.