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NCT05822583

PHASE4

Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

285

Start Date

2023-07-06

Completion Date

2025-08-11

Last Updated

2026-08-31

Healthy Volunteers

Conditions

COVID-19

Interventions

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)

DRUG

Placebo group

Placebo group (IV infusion of normal saline) + baseline IM

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 (\<1.0 x 10 9 cells/µL) or lymphopenia (\<1.0 x 10 9 cells/µL) * Participant has untreated advanced HIV (known CD4 \<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.

Locations (127)

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

Birmingham, Alabama, United States

Banner University Medical Center Tucson (Site 206-004)

Tucson, Arizona, United States

Southern Arizona VA Healthcare System (Site 074-009)

Tucson, Arizona, United States

UC Davis Health (Site 203-004)

Davis, California, United States

UCSF Fresno (Site 203-005)

Fresno, California, United States

VA Loma Linda Healthcare System (074-017)

Loma Linda, California, United States

MemorialCare Health System (066-003)

Long Beach, California, United States

VA Long Beach Healthcare System (074-026)

Long Beach, California, United States

Cedars-Sinai Medical Center (208-002)

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center (Site 203-002)

Los Angeles, California, United States

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

Mather, California, United States

VA San Diego Healthcare System (074-016)

San Diego, California, United States

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

San Francisco, California, United States

UCSF Medical Center at Mount Zion (203-007)

San Francisco, California, United States

San Francisco VAMC (Site 074-002)

San Francisco, California, United States

UCSF Medical Center (Site 203-001)

San Francisco, California, United States

Stanford University Hospital & Clinics (Site 203-003)

Stanford, California, United States

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

Aurora, Colorado, United States

University of Colorado Hospital (Site 204-001)

Aurora, Colorado, United States

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

Denver, Colorado, United States

Yale University (Site 025-001)

New Haven, Connecticut, United States

MedStar Health Research Institute (Site 009-021)

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

Washington DC VA Medical Center (Site 009-004)

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

Tampa General Hospital (032-001)

Tampa, Florida, United States

Emory Grady (Site 301-032)

Atlanta, Georgia, United States

Hope Clinic, Emory University (Site 301-031)

Decatur, Georgia, United States

University of Illinois at Chicago (008-012)

Chicago, Illinois, United States

Lutheran Medical Group (301-010)

Fort Wayne, Indiana, United States

University of Kansas Medical Center (Site 080-044)

Kansas City, Kansas, United States

Massachusetts General Hospital (202-002)

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center (202-001)

Boston, Massachusetts, United States

Lahey Hospital and Medical Center (Site 213-001)

Burlington, Massachusetts, United States

Baystate Medical Center (Site 201-001)

Springfield, Massachusetts, United States

University of Massachusetts Chan Medical School (080-007)

Worcester, Massachusetts, United States

VA Ann Arbor Healthcare System (Site 074-028)

Ann Arbor, Michigan, United States

University of Michigan Medical Center (205-001)

Ann Arbor, Michigan, United States

Henry Ford Health System (014-001)

Detroit, Michigan, United States

Sinai-Grace Hospital (Site 205-005)

Detroit, Michigan, United States

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

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Mississippi Medical Center (Site 202-005)

Jackson, Mississippi, United States

Washington University School of Medicine (Site 003-001)

St Louis, Missouri, United States

University of Nebraska Medical Center (Site 080-045)

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center (301-024)

Lebanon, New Hampshire, United States

Cooper University Hospital (019-001)

Camden, New Jersey, United States

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

Newark, New Jersey, United States

University of New Mexico Hospital (Site 213-008)

Albuquerque, New Mexico, United States

NYU Brooklyn (301-033)

Brooklyn, New York, United States

New York Presbyterian Queens (003-005)

Flushing, New York, United States

NYU Long Island (301-034)

Mineola, New York, United States

New York University Langone Health (301-013)

New York, New York, United States

NYC Health + Hospital Harlem (Site 003-003)

New York, New York, United States

Weill Cornell Clinical Research Unit (065-001)

New York, New York, United States

Mount Sinai Medical Center (Site 301-012)

New York, New York, United States

Lincoln Medical Center (Site 003-016)

The Bronx, New York, United States

James J. Peters VAMC (Site 023-003)

The Bronx, New York, United States

Duke University Hospital (Site 301-006)

Durham, North Carolina, United States

Wake Forest Baptist Health (Site 210-001)

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation (Site 207-001)

Cleveland, Ohio, United States

Oregon Health and Science University (208-003)

Portland, Oregon, United States

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

Hershey, Pennsylvania, United States

Rhode Island Hospital (Site 080-036)

Providence, Rhode Island, United States

The Miriam Hospital (Site 080-039)

Providence, Rhode Island, United States

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

Charleston, South Carolina, United States

Medical University of South Carolina (Site 210-002)

Charleston, South Carolina, United States

Vanderbilt University Medical Center (Site 212-001)

Nashville, Tennessee, United States

Hendrick Medical Center (Site 080-014)

Abilene, Texas, United States

CHRISTUS Spohn Shoreline Hospital (080-001)

Corpus Christi, Texas, United States

Parkland Health and Hospital Systems (084-002)

Dallas, Texas, United States

Baylor, Scott and White Health (301-003)

Dallas, Texas, United States

UT Southwestern Medical Center (084-001)

Dallas, Texas, United States

Houston Methodist Research Institute (Site 301-028)

Houston, Texas, United States

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

Houston, Texas, United States

UT Health San Antonio (Site 009-022)

San Antonio, Texas, United States

Intermountain Medical Center (Site 211-001)

Murray, Utah, United States

University of Utah Hospital (211-002)

Salt Lake City, Utah, United States

Salem VA Medical Center (Site 074-014)

Salem, Virginia, United States

Harborview Medical Center (208-001)

Seattle, Washington, United States

Providence (Sacred Heart) (213-004)

Spokane, Washington, United States

West Virginia University Medicine (Site 301-023)

Morgantown, West Virginia, United States

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

Madison, Wisconsin, United States

Froedtert Memorial Lutheran Hospital (052-001)

Milwaukee, Wisconsin, United States

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

Sydney, New South Wales, Australia

Westmead Hospital (Site 612-058)

Westmead, New South Wales, Australia

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

Brisbane, Queensland, Australia

Monash Health (612-009)

Clayton, Victoria, Australia

Austin Health (612-020)

Heidelberg, Victoria, Australia

The Alfred Hospital (612-017)

Melbourne, Victoria, Australia

Odense University Hospital (625-004)

Odense, C, Denmark

Aalborg Hospital (Site 625-005)

Aalborg, Denmark

Aarhus Universitetshospital, Skejby (Site 625-002)

Aarhus, Denmark

Rigshospitalet, CHIP (Site 625-006)

Copenhagen, Denmark

Bispebjerg Hospital (Site 625-013)

Copenhagen, Denmark

Herlev/Gentofte Hospital (Site 625-012

Hellerup, Denmark

Nordsjællands Hospital, Hillerød (Site 625-009)

Hillerød, Denmark

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

Hvidovre, Denmark

Hôpital Saint André (Site 631-041)

Bordeaux, France

AIDS and Clinical Immunology Research Center (627-201)

Tbilisi, Georgia

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

Cologne, Germany

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

Athens, Attica, Greece

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

Athens, Attica, Greece

Attikon University General Hospital (Site 635-009)

Athens, Attica, Greece

Democritus University of Thrace (635-021)

Alexandroupoli, Evros, Greece

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

Chennai, Tamil Nadu, India

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

Dublin, Ireland

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

Abuja, Federal Capital Territory, Nigeria

Wojewodzki Szpital Zakazny (Site 625-302)

Warsaw, Poland

Tan Tock Seng Hospital (Site 612-201)

Singapore, Singapore

Seoul National University Bundang Hospital (612-904)

Seongnam, South Korea

National Medical Center (612-905)

Seoul, South Korea

Asan Medical Center (612-901)

Seoul, South Korea

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

Seoul, South Korea

Chung-Ang University Hospital (612-902)

Seoul, South Korea

Hospital Universitari Germans Trias i Pujol (626-003)

Badalona, Barcelona, Spain

Hospital del Mar (626-025)

Barcelona, Spain

Hospital Universitari Vall d'Hebron (626-033)

Barcelona, Spain

Hospital Clinic de Barcelona (626-004)

Barcelona, Spain

Hospital Universitario La Paz (Site 626-012)

Madrid, Spain

Karolinska University Hospital, Solna (Site 625-206)

Stockholm, Sweden

University Hospital Basel (636-004)

Basel, Switzerland

Siriraj Hospital (613-002)

Bangkok Noi, Bangkok, Thailand

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

Bangkok, Thailand

Khon Kaen University, Srinagarind Hospital (613-003)

Khon Kaen, Thailand

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

Ivano-Frankivsk, Ukraine

Treatment and Diagnostic Center ADONIS Plus (627-304)

Kyiv, Ukraine

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

Zhytomyr, Ukraine

University Hospital Plymouth NHS Trust (Site 634-014)

Plymouth, Devon, United Kingdom

Clinical Research Directory

Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (127)