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

NCT05822583 | Completed Phase 4 FDA Drug

• 1 other identifier: STRIVE
• Study Type: interventional
• Target: 285
• Locations: 19 countries
• Sites: 127

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• time to sustained recovery though Day 60

  baseline to day 60

• all-cause mortality though Day 60

  baseline to day 60

• time to progression

  baseline to day 60

• Three-category ordinal outcome

  Day 60

• the pulmonary ordinal outcome

  Day 5, 14, and 28

Study Arms (2)

active treatment group

EXPERIMENTAL

Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM

Drug: abatacept infusion

Control group

PLACEBO COMPARATOR

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

Drug: Placebo group

Interventions

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)

active treatment group

Placebo group DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)
• 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.
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (127)

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

Birmingham, Alabama, 35233, United States

Location

Banner University Medical Center Tucson (Site 206-004)

Tucson, Arizona, 85719, United States

Location

Southern Arizona VA Healthcare System (Site 074-009)

Tucson, Arizona, 85723, United States

Location

UC Davis Health (Site 203-004)

Davis, California, 95616, United States

Location

UCSF Fresno (Site 203-005)

Fresno, California, 93721, United States

Location

VA Loma Linda Healthcare System (074-017)

Loma Linda, California, 92357, United States

Location

MemorialCare Health System (066-003)

Long Beach, California, 90806, United States

Location

VA Long Beach Healthcare System (074-026)

Long Beach, California, 90822, United States

Location

Cedars-Sinai Medical Center (208-002)

Los Angeles, California, 90048, United States

Location

Ronald Reagan UCLA Medical Center (Site 203-002)

Los Angeles, California, 90095, United States

Location

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

Mather, California, 95655, United States

Location

VA San Diego Healthcare System (074-016)

San Diego, California, 92161, United States

Location

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

San Francisco, California, 94110, United States

Location

UCSF Medical Center at Mount Zion (203-007)

San Francisco, California, 94115, United States

Location

San Francisco VAMC (Site 074-002)

San Francisco, California, 94121, United States

Location

UCSF Medical Center (Site 203-001)

San Francisco, California, 94143, United States

Location

Stanford University Hospital & Clinics (Site 203-003)

Stanford, California, 94305, United States

Location

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

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital (Site 204-001)

Aurora, Colorado, 80045, United States

Location

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

Denver, Colorado, 80204, United States

Location

Yale University (Site 025-001)

New Haven, Connecticut, 06510, United States

Location

MedStar Health Research Institute (Site 009-021)

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

Location

Washington DC VA Medical Center (Site 009-004)

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

Location

Tampa General Hospital (032-001)

Tampa, Florida, 33606, United States

Location

Emory Grady (Site 301-032)

Atlanta, Georgia, 30303, United States

Location

Hope Clinic, Emory University (Site 301-031)

Decatur, Georgia, 30030, United States

Location

University of Illinois at Chicago (008-012)

Chicago, Illinois, 60612, United States

Location

Lutheran Medical Group (301-010)

Fort Wayne, Indiana, 46804, United States

Location

University of Kansas Medical Center (Site 080-044)

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital (202-002)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center (202-001)

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital and Medical Center (Site 213-001)

Burlington, Massachusetts, 01805, United States

Location

Baystate Medical Center (Site 201-001)

Springfield, Massachusetts, 01199, United States

Location

University of Massachusetts Chan Medical School (080-007)

Worcester, Massachusetts, 01655, United States

Location

VA Ann Arbor Healthcare System (Site 074-028)

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Medical Center (205-001)

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System (014-001)

Detroit, Michigan, 48202, United States

Location

Sinai-Grace Hospital (Site 205-005)

Detroit, Michigan, 48235, United States

Location

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

Minneapolis, Minnesota, 55455, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center (Site 202-005)

Jackson, Mississippi, 39216, United States

Location

Washington University School of Medicine (Site 003-001)

St Louis, Missouri, 63310, United States

Location

University of Nebraska Medical Center (Site 080-045)

Omaha, Nebraska, 68198, United States

Location

Dartmouth-Hitchcock Medical Center (301-024)

Lebanon, New Hampshire, 03756, United States

Location

Cooper University Hospital (019-001)

Camden, New Jersey, 08103, United States

Location

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

Newark, New Jersey, 07103, United States

Location

University of New Mexico Hospital (Site 213-008)

Albuquerque, New Mexico, 87106, United States

Location

NYU Brooklyn (301-033)

Brooklyn, New York, 11220, United States

Location

New York Presbyterian Queens (003-005)

Flushing, New York, 11355, United States

Location

NYU Long Island (301-034)

Mineola, New York, 11501, United States

Location

New York University Langone Health (301-013)

New York, New York, 10016, United States

Location

NYC Health + Hospital Harlem (Site 003-003)

New York, New York, 10037, United States

Location

Weill Cornell Clinical Research Unit (065-001)

New York, New York, 10065, United States

Location

Mount Sinai Medical Center (Site 301-012)

New York, New York, 11234, United States

Location

Lincoln Medical Center (Site 003-016)

The Bronx, New York, 10451, United States

Location

James J. Peters VAMC (Site 023-003)

The Bronx, New York, 10468, United States

Location

Duke University Hospital (Site 301-006)

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health (Site 210-001)

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation (Site 207-001)

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University (208-003)

Portland, Oregon, 97239, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

Rhode Island Hospital (Site 080-036)

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital (Site 080-039)

Providence, Rhode Island, 02906, United States

Location

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

Charleston, South Carolina, 29401, United States

Location

Medical University of South Carolina (Site 210-002)

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center (Site 212-001)

Nashville, Tennessee, 37232, United States

Location

Hendrick Medical Center (Site 080-014)

Abilene, Texas, 79602, United States

Location

CHRISTUS Spohn Shoreline Hospital (080-001)

Corpus Christi, Texas, 78404, United States

Location

Parkland Health and Hospital Systems (084-002)

Dallas, Texas, 75235, United States

Location

Baylor, Scott and White Health (301-003)

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center (084-001)

Dallas, Texas, 75390, United States

Location

Houston Methodist Research Institute (Site 301-028)

Houston, Texas, 77030, United States

Location

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

Houston, Texas, 77030, United States

Location

UT Health San Antonio (Site 009-022)

San Antonio, Texas, 78229, United States

Location

Intermountain Medical Center (Site 211-001)

Murray, Utah, 84107, United States

Location

University of Utah Hospital (211-002)

Salt Lake City, Utah, 84108, United States

Location

Salem VA Medical Center (Site 074-014)

Salem, Virginia, 24153, United States

Location

Harborview Medical Center (208-001)

Seattle, Washington, 98104, United States

Location

Providence (Sacred Heart) (213-004)

Spokane, Washington, 99204, United States

Location

West Virginia University Medicine (Site 301-023)

Morgantown, West Virginia, 26506, United States

Location

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

Madison, Wisconsin, 53705, United States

Location

Froedtert Memorial Lutheran Hospital (052-001)

Milwaukee, Wisconsin, 53226, United States

Location

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

Sydney, New South Wales, 2010, Australia

Location

Westmead Hospital (Site 612-058)

Westmead, New South Wales, 2145, Australia

Location

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

Brisbane, Queensland, 4029, Australia

Location

Monash Health (612-009)

Clayton, Victoria, 3168, Australia

Location

Austin Health (612-020)

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital (612-017)

Melbourne, Victoria, 3004, Australia

Location

Odense University Hospital (625-004)

Odense, C, 5000, Denmark

Location

Aalborg Hospital (Site 625-005)

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital, Skejby (Site 625-002)

Aarhus, 8200, Denmark

Location

Rigshospitalet, CHIP (Site 625-006)

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital (Site 625-013)

Copenhagen, 2400, Denmark

Location

Herlev/Gentofte Hospital (Site 625-012

Hellerup, 2900, Denmark

Location

Nordsjællands Hospital, Hillerød (Site 625-009)

Hillerød, 3400, Denmark

Location

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

Hvidovre, 2650, Denmark

Location

Hôpital Saint André (Site 631-041)

Bordeaux, 33000, France

Location

AIDS and Clinical Immunology Research Center (627-201)

Tbilisi, 0159, Georgia

Location

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

Cologne, 50937, Germany

Location

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

Athens, Attica, 11527, Greece

Location

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

Athens, Attica, 11527, Greece

Location

Attikon University General Hospital (Site 635-009)

Athens, Attica, 12462, Greece

Location

Democritus University of Thrace (635-021)

Alexandroupoli, Evros, 68131, Greece

Location

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

Chennai, Tamil Nadu, 600113, India

Location

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

Dublin, D04 T6F4, Ireland

Location

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

Abuja, Federal Capital Territory, Nigeria

Location

Wojewodzki Szpital Zakazny (Site 625-302)

Warsaw, 01-201, Poland

Location

Tan Tock Seng Hospital (Site 612-201)

Singapore, 308433, Singapore

Location

Seoul National University Bundang Hospital (612-904)

Seongnam, 13620, South Korea

Location

National Medical Center (612-905)

Seoul, 04564, South Korea

Location

Asan Medical Center (612-901)

Seoul, 05505, South Korea

Location

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

Seoul, 06591, South Korea

Location

Chung-Ang University Hospital (612-902)

Seoul, 06973, South Korea

Location

Hospital Universitari Germans Trias i Pujol (626-003)

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar (626-025)

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron (626-033)

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona (626-004)

Barcelona, 08036, Spain

Location

Hospital Universitario La Paz (Site 626-012)

Madrid, 28046, Spain

Location

Karolinska University Hospital, Solna (Site 625-206)

Stockholm, 171 76, Sweden

Location

University Hospital Basel (636-004)

Basel, 4031, Switzerland

Location

Siriraj Hospital (613-002)

Bangkok Noi, Bangkok, 10700, Thailand

Location

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

Bangkok, 10330, Thailand

Location

Khon Kaen University, Srinagarind Hospital (613-003)

Khon Kaen, 40002, Thailand

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

Treatment and Diagnostic Center ADONIS Plus (627-304)

Kyiv, 02002, Ukraine

Location

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

Zhytomyr, 10002, Ukraine

Location

University Hospital Plymouth NHS Trust (Site 634-014)

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cavan Reilly, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Christina Barkauskas, MD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: April 21, 2023
• Study Start: July 6, 2023
• Primary Completion: June 21, 2025
• Study Completion: August 11, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

KR (5); TH (3); US (82); IN (1); GB (1); DE (1); CH (1); GR (4); FR (1); IE (1); AU (6); NG (1); SE (1); SG (1); DK (8); ES (5); PL (1); UA (3); GE (1)