Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial
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
- COVID-19
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 (<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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental active treatment group |
Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM |
|
|
Placebo Comparator Control group |
Placebo group (IV infusion of normal saline) + baseline IM |
|
Recruiting Locations
University of Alabama Birmingham University Hospital (Site 213-002)
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Banner University Medical Center Tucson (Site 206-004)
Tucson, Arizona 85719
Tucson, Arizona 85719
Southern Arizona VA Healthcare System (Site 074-009)
Tucson, Arizona 85723
Tucson, Arizona 85723
UC Davis Health (Site 203-004)
Davis, California 95616
Davis, California 95616
UCSF Fresno (Site 203-005)
Fresno, California 93721
Fresno, California 93721
VA Loma Linda Healthcare System (074-017)
Loma Linda, California 92357
Loma Linda, California 92357
MemorialCare Health System (066-003)
Long Beach, California 90806
Long Beach, California 90806
VA Long Beach Healthcare System (074-026)
Long Beach, California 90822
Long Beach, California 90822
Ronald Reagan UCLA Medical Center (Site 203-002)
Los Angeles, California 90095
Los Angeles, California 90095
VA Northern California Health Care System (Site 074-023)
Mather, California 95655
Mather, California 95655
VA San Diego Healthcare System (074-016)
San Diego, California 92161
San Diego, California 92161
Zuckerberg San Francisco General Hospital and Trauma Center (213-007)
San Francisco, California 94110
San Francisco, California 94110
UCSF Medical Center at Mount Zion (203-007)
San Francisco, California 94115
San Francisco, California 94115
San Francisco VAMC (Site 074-002)
San Francisco, California 94121
San Francisco, California 94121
UCSF Medical Center (Site 203-001)
San Francisco, California 94143
San Francisco, California 94143
Stanford University Hospital & Clinics (Site 203-003)
Stanford, California 94305
Stanford, California 94305
Rocky Mountain Regional VA Medical Center (Site 074-010)
Aurora, Colorado 80045
Aurora, Colorado 80045
University of Colorado Hospital (Site 204-001)
Aurora, Colorado 80045
Aurora, Colorado 80045
Public Health Institute at Denver Health (Site 017-004)
Denver, Colorado 80204
Denver, Colorado 80204
Yale University (Site 025-001)
New Haven, Connecticut 06510
New Haven, Connecticut 06510
MedStar Health Research Institute (Site 009-021)
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Washington DC VA Medical Center (Site 009-004)
Washington, District of Columbia 20422
Washington, District of Columbia 20422
Tampa General Hospital (032-001)
Tampa, Florida 33606
Tampa, Florida 33606
Hope Clinic, Emory University (Site 301-031)
Decatur, Georgia 30030
Decatur, Georgia 30030
University of Illinois at Chicago (008-012)
Chicago, Illinois 60612
Chicago, Illinois 60612
Lutheran Medical Group (301-010)
Fort Wayne, Indiana 46804
Fort Wayne, Indiana 46804
University of Kansas Medical Center (Site 080-044)
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Massachusetts General Hospital (202-002)
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Beth Israel Deaconess Medical Center (202-001)
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Lahey Hospital and Medical Center (Site 213-001)
Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
Baystate Medical Center (Site 201-001)
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
University of Massachusetts Chan Medical School (080-007)
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
VA Ann Arbor Healthcare System (Site 074-028)
Ann Arbor, Michigan 48105
Ann Arbor, Michigan 48105
University of Michigan Medical Center (205-001)
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Henry Ford Health System (014-001)
Detroit, Michigan 48202
Detroit, Michigan 48202
Sinai-Grace Hospital (Site 205-005)
Detroit, Michigan 48235
Detroit, Michigan 48235
M Health Fairview University of Minnesota Medical Center (112-001)
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
University of Minnesota
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
University of Mississippi Medical Center (Site 202-005)
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Washington University School of Medicine (Site 003-001)
Saint Louis, Missouri 63310
Saint Louis, Missouri 63310
University of Nebraska Medical Center (Site 080-045)
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Dartmouth-Hitchcock Medical Center (301-024)
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Cooper University Hospital (019-001)
Camden, New Jersey 08103
Camden, New Jersey 08103
University of New Mexico Hospital (Site 213-008)
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
James J. Peters VAMC (Site 023-003)
Bronx, New York 10468
Bronx, New York 10468
New York University Langone Health (301-013)
New York, New York 10016
New York, New York 10016
Weill Cornell Clinical Research Unit (065-001)
New York, New York 10065
New York, New York 10065
Mount Sinai Medical Center (Site 301-012)
New York, New York 11234
New York, New York 11234
Duke University Hospital (Site 301-006)
Durham, North Carolina 27710
Durham, North Carolina 27710
Wake Forest Baptist Health (Site 210-001)
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Oregon Health and Science University (208-003)
Portland, Oregon 97239
Portland, Oregon 97239
Penn State Health Milton S. Hershey Medical Center (Site 209-002)
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Rhode Island Hospital (Site 080-036)
Providence, Rhode Island 02903
Providence, Rhode Island 02903
The Miriam Hospital (Site 080-039)
Providence, Rhode Island 02906
Providence, Rhode Island 02906
Ralph H. Johnson VA Medical Center (074-015)
Charleston, South Carolina 29401
Charleston, South Carolina 29401
Medical University of South Carolina (Site 210-002)
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Hendrick Medical Center (Site 080-014)
Abilene, Texas 79602
Abilene, Texas 79602
CHRISTUS Spohn Shoreline Hospital (080-001)
Corpus Christi, Texas 78404
Corpus Christi, Texas 78404
Parkland Health and Hospital Systems (084-002)
Dallas, Texas 75235
Dallas, Texas 75235
Baylor, Scott and White Health (301-003)
Dallas, Texas 75246
Dallas, Texas 75246
UT Southwestern Medical Center (084-001)
Dallas, Texas 75390
Dallas, Texas 75390
Houston Methodist Research Institute (Site 301-028)
Houston, Texas 77030
Houston, Texas 77030
University of Texas Health Science Center (Site 203-006)
Houston, Texas 77030
Houston, Texas 77030
UT Health San Antonio (Site 009-022)
San Antonio, Texas 78229
San Antonio, Texas 78229
Intermountain Medical Center (Site 211-001)
Murray, Utah 84107
Murray, Utah 84107
University of Utah Hospital (211-002)
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
Salem VA Medical Center (Site 074-014)
Salem, Virginia 24153
Salem, Virginia 24153
Harborview Medical Center (208-001)
Seattle, Washington 98104
Seattle, Washington 98104
Providence (Sacred Heart) (213-004)
Spokane, Washington 99204
Spokane, Washington 99204
West Virginia University Medicine (Site 301-023)
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
William S. Middleton Memorial Veterans Hospital (074-030)
Madison, Wisconsin 53705
Madison, Wisconsin 53705
Froedtert Memorial Lutheran Hospital (052-001)
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT05822583
- Status
- Recruiting
- Sponsor
- University of Minnesota