COVID-19Phase 4NCT05822583
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
A Phase 4 study testing abatacept infusion in people with COVID-19, run by University of Minnesota at 127 sites in 19 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- abatacept infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 127 sitesin 19 countries
- Study dates
- 6 Jul 2023to 11 Aug 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
127 sites in 19 countries.
127 sites in 19 countries
United States82 sites
Hendrick Medical Center (Site 080-014)
Abilene, Texas, 79602
University of New Mexico Hospital (Site 213-008)
Albuquerque, New Mexico, 87106
VA Ann Arbor Healthcare System (Site 074-028)
Ann Arbor, Michigan, 48105
University of Michigan Medical Center (205-001)
Ann Arbor, Michigan, 48109
Emory Grady (Site 301-032)
Atlanta, Georgia, 30303
Rocky Mountain Regional VA Medical Center (Site 074-010)
Aurora, Colorado, 80045
University of Colorado Hospital (Site 204-001)
Aurora, Colorado, 80045
University of Alabama Birmingham University Hospital (Site 213-002)
Birmingham, Alabama, 35233
Massachusetts General Hospital (202-002)
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center (202-001)
Boston, Massachusetts, 02215
NYU Brooklyn (301-033)
Brooklyn, New York, 11220
Lahey Hospital and Medical Center (Site 213-001)
Burlington, Massachusetts, 01805
Cooper University Hospital (019-001)
Camden, New Jersey, 08103
Ralph H. Johnson VA Medical Center (074-015)
Charleston, South Carolina, 29401
Medical University of South Carolina (Site 210-002)
Charleston, South Carolina, 29425
University of Illinois at Chicago (008-012)
Chicago, Illinois, 60612
Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio, 44195
CHRISTUS Spohn Shoreline Hospital (080-001)
Corpus Christi, Texas, 78404
Parkland Health and Hospital Systems (084-002)
Dallas, Texas, 75235
Baylor, Scott and White Health (301-003)
Dallas, Texas, 75246
UT Southwestern Medical Center (084-001)
Dallas, Texas, 75390
UC Davis Health (Site 203-004)
Davis, California, 95616
Hope Clinic, Emory University (Site 301-031)
Decatur, Georgia, 30030
Public Health Institute at Denver Health (Site 017-004)
Denver, Colorado, 80204
Henry Ford Health System (014-001)
Detroit, Michigan, 48202
Sinai-Grace Hospital (Site 205-005)
Detroit, Michigan, 48235
Duke University Hospital (Site 301-006)
Durham, North Carolina, 27710
New York Presbyterian Queens (003-005)
Flushing, New York, 11355
Lutheran Medical Group (301-010)
Fort Wayne, Indiana, 46804
UCSF Fresno (Site 203-005)
Fresno, California, 93721
Penn State Health Milton S. Hershey Medical Center (Site 209-002)
Hershey, Pennsylvania, 17033
Houston Methodist Research Institute (Site 301-028)
Houston, Texas, 77030
University of Texas Health Science Center (Site 203-006)
Houston, Texas, 77030
University of Mississippi Medical Center (Site 202-005)
Jackson, Mississippi, 39216
University of Kansas Medical Center (Site 080-044)
Kansas City, Kansas, 66160
Dartmouth-Hitchcock Medical Center (301-024)
Lebanon, New Hampshire, 03756
VA Loma Linda Healthcare System (074-017)
Loma Linda, California, 92357
MemorialCare Health System (066-003)
Long Beach, California, 90806
VA Long Beach Healthcare System (074-026)
Long Beach, California, 90822
Cedars-Sinai Medical Center (208-002)
Los Angeles, California, 90048
Ronald Reagan UCLA Medical Center (Site 203-002)
Los Angeles, California, 90095
William S. Middleton Memorial Veterans Hospital (074-030)
Madison, Wisconsin, 53705
VA Northern California Health Care System (Site 074-023)
Mather, California, 95655
Froedtert Memorial Lutheran Hospital (052-001)
Milwaukee, Wisconsin, 53226
NYU Long Island (301-034)
Mineola, New York, 11501
M Health Fairview University of Minnesota Medical Center (112-001)
Minneapolis, Minnesota, 55455
University of Minnesota
Minneapolis, Minnesota, 55455
West Virginia University Medicine (Site 301-023)
Morgantown, West Virginia, 26506
Intermountain Medical Center (Site 211-001)
Murray, Utah, 84107
Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee, 37232
Yale University (Site 025-001)
New Haven, Connecticut, 06510
New York University Langone Health (301-013)
New York, New York, 10016
NYC Health + Hospital Harlem (Site 003-003)
New York, New York, 10037
Weill Cornell Clinical Research Unit (065-001)
New York, New York, 10065
Mount Sinai Medical Center (Site 301-012)
New York, New York, 11234
New Jersey Medical School Clinical Research Center (028-001)
Newark, New Jersey, 07103
University of Nebraska Medical Center (Site 080-045)
Omaha, Nebraska, 68198
Oregon Health and Science University (208-003)
Portland, Oregon, 97239
Rhode Island Hospital (Site 080-036)
Providence, Rhode Island, 02903
The Miriam Hospital (Site 080-039)
Providence, Rhode Island, 02906
Salem VA Medical Center (Site 074-014)
Salem, Virginia, 24153
University of Utah Hospital (211-002)
Salt Lake City, Utah, 84108
UT Health San Antonio (Site 009-022)
San Antonio, Texas, 78229
VA San Diego Healthcare System (074-016)
San Diego, California, 92161
Zuckerberg San Francisco General Hospital and Trauma Center (213-007)
San Francisco, California, 94110
UCSF Medical Center at Mount Zion (203-007)
San Francisco, California, 94115
San Francisco VAMC (Site 074-002)
San Francisco, California, 94121
UCSF Medical Center (Site 203-001)
San Francisco, California, 94143
Harborview Medical Center (208-001)
Seattle, Washington, 98104
Providence (Sacred Heart) (213-004)
Spokane, Washington, 99204
Baystate Medical Center (Site 201-001)
Springfield, Massachusetts, 01199
Washington University School of Medicine (Site 003-001)
St Louis, Missouri, 63310
Stanford University Hospital & Clinics (Site 203-003)
Stanford, California, 94305
Tampa General Hospital (032-001)
Tampa, Florida, 33606
Lincoln Medical Center (Site 003-016)
The Bronx, New York, 10451
James J. Peters VAMC (Site 023-003)
The Bronx, New York, 10468
Banner University Medical Center Tucson (Site 206-004)
Tucson, Arizona, 85719
Southern Arizona VA Healthcare System (Site 074-009)
Tucson, Arizona, 85723
MedStar Health Research Institute (Site 009-021)
Washington D.C., District of Columbia, 20010
Washington DC VA Medical Center (Site 009-004)
Washington D.C., District of Columbia, 20422
Wake Forest Baptist Health (Site 210-001)
Winston-Salem, North Carolina, 27157
University of Massachusetts Chan Medical School (080-007)
Worcester, Massachusetts, 01655
Denmark8 sites
Aalborg Hospital (Site 625-005)
Aalborg, 9000
Aarhus Universitetshospital, Skejby (Site 625-002)
Aarhus, 8200
Rigshospitalet, CHIP (Site 625-006)
Copenhagen, 2100
Bispebjerg Hospital (Site 625-013)
Copenhagen, 2400
Herlev/Gentofte Hospital (Site 625-012
Hellerup, 2900
Nordsjællands Hospital, Hillerød (Site 625-009)
Hillerød, 3400
Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001)
Hvidovre, 2650
Odense University Hospital (625-004)
Odense, C, 5000
Australia6 sites
Royal Brisbane and Women's Hospital (612-055)
Brisbane, Queensland, 4029
Monash Health (612-009)
Clayton, Victoria, 3168
Austin Health (612-020)
Heidelberg, Victoria, 3084
The Alfred Hospital (612-017)
Melbourne, Victoria, 3004
St. Vincent's Hospital (Site 612-002)
Sydney, New South Wales, 2010
Westmead Hospital (Site 612-058)
Westmead, New South Wales, 2145
South Korea5 sites
Seoul National University Bundang Hospital (612-904)
Seongnam, 13620
National Medical Center (612-905)
Seoul, 04564
Asan Medical Center (612-901)
Seoul, 05505
Seoul St. Mary's Hospital (Site 612-903)
Seoul, 06591
Chung-Ang University Hospital (612-902)
Seoul, 06973
Spain5 sites
Hospital Universitari Germans Trias i Pujol (626-003)
Badalona, Barcelona, 08916
Hospital del Mar (626-025)
Barcelona, 08003
Hospital Universitari Vall d'Hebron (626-033)
Barcelona, 08035
Hospital Clinic de Barcelona (626-004)
Barcelona, 08036
Hospital Universitario La Paz (Site 626-012)
Madrid, 28046
Greece4 sites
Democritus University of Thrace (635-021)
Alexandroupoli, Evros, 68131
1st Respiratory Medicine Department, Athens University Medical School (635-015)
Athens, Attica, 11527
3rd Dept of Medicine, Medical School, NKUA (635-022)
Athens, Attica, 11527
Attikon University General Hospital (Site 635-009)
Athens, Attica, 12462
Thailand3 sites
Chulalongkorn University and The HIV-NAT (Site 613-001)
Bangkok, 10330
Siriraj Hospital (613-002)
Bangkok Noi, Bangkok, 10700
Khon Kaen University, Srinagarind Hospital (613-003)
Khon Kaen, 40002
Ukraine3 sites
Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302)
Ivano-Frankivsk, 76018
Treatment and Diagnostic Center ADONIS Plus (627-304)
Kyiv, 02002
Hospital #1 of Zhytomyr City Council (627-303)
Zhytomyr, 10002
Georgia1 site
AIDS and Clinical Immunology Research Center (627-201)
Tbilisi, 0159
Germany1 site
Klinik I für Innere Medizin der Universität zu Köln (622-008)
Cologne, 50937
India1 site
Chennai Antiviral Research and Treatment Clinical Research Site (Site 612-402)
Chennai, Tamil Nadu, 600113
Ireland1 site
St Vincent's University Hospital (Site 634-103)
Dublin, D04 T6F4
Nigeria1 site
Institute of Human Virology-Nigeria (IHVN) (612-601)
Abuja, Federal Capital Territory
Sweden1 site
Karolinska University Hospital, Solna (Site 625-206)
Stockholm, 171 76
United Kingdom1 site
University Hospital Plymouth NHS Trust (Site 634-014)
Plymouth, Devon, PL6 8DH
About this study
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
- Being tested
- abatacept infusion, Placebo group
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abatacept infusionDrug
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 groupDrug
Placebo group (IV infusion of normal saline) + baseline IM
| Study group | Role | What they receive |
|---|---|---|
| active treatment group | Experimental | Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM Receives: Drug: abatacept infusion |
| Control group | Placebo comparator | Placebo group (IV infusion of normal saline) + baseline IM Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recovered by Day 60
Number of participants who recovered by Day 60. Recovery was assessed through Day 60 using the Days to Recovery Scale.
Measured: Through Day 60
Secondary outcomes (4)
Safety Outcome Through Day 28
Number of participants who experienced death, SAE, clinical organ failure, serious infections, or a Grade 3 or 4 event through day 28
Measured: Through Day 28
Composite of Death or CRIs
Number of participants who experienced death or CRIs through day 120
Measured: Through Day 120
Number of Participants With Clinical Progression or Death Through Day 60
Number of participants who experienced clinical progression or death through Day 60.
Measured: Through Day 60
Number of Participants With Sustained Recovery Through Day 60
Number of participants who returned to their baseline residence/home for at least 14 consecutive days through Day 60.
Measured: Through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start6 Jul 2023
- Primary completion21 Jun 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cavan Reilly, PhD, Principal investigator, University of MinnesotaChristina Barkauskas, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822583
- Sponsor's protocol ID
- STRIVE
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2023
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No