COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-06

Study Completion:2025-08-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05822583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Cavan Reilly, PhD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Christina Barkauskas, MD

STUDY_CHAIR

Duke University

Study Locations (Sites)

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

Birmingham, Alabama, 35233

United States

Banner University Medical Center Tucson (Site 206-004)

Tucson, Arizona, 85719

United States

Southern Arizona VA Healthcare System (Site 074-009)

Tucson, Arizona, 85723

United States

UC Davis Health (Site 203-004)

Davis, California, 95616

United States

UCSF Fresno (Site 203-005)

Fresno, California, 93721

United States

VA Loma Linda Healthcare System (074-017)

Loma Linda, California, 92357

United States

MemorialCare Health System (066-003)

Long Beach, California, 90806

United States

VA Long Beach Healthcare System (074-026)

Long Beach, California, 90822

United States

Cedars-Sinai Medical Center (208-002)

Los Angeles, California, 90048

United States

Ronald Reagan UCLA Medical Center (Site 203-002)

Los Angeles, California, 90095

United States

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

Mather, California, 95655

United States

VA San Diego Healthcare System (074-016)

San Diego, California, 92161

United States

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

San Francisco, California, 94110

United States

UCSF Medical Center at Mount Zion (203-007)

San Francisco, California, 94115

United States

San Francisco VAMC (Site 074-002)

San Francisco, California, 94121

United States

UCSF Medical Center (Site 203-001)

San Francisco, California, 94143

United States

Stanford University Hospital & Clinics (Site 203-003)

Stanford, California, 94305

United States

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

Aurora, Colorado, 80045

United States

University of Colorado Hospital (Site 204-001)

Aurora, Colorado, 80045

United States

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

Denver, Colorado, 80204

United States

Yale University (Site 025-001)

New Haven, Connecticut, 06510

United States

MedStar Health Research Institute (Site 009-021)

Washington D.C., District of Columbia, 20010

United States

Washington DC VA Medical Center (Site 009-004)

Washington D.C., District of Columbia, 20422

United States

Tampa General Hospital (032-001)

Tampa, Florida, 33606

United States

Emory Grady (Site 301-032)

Atlanta, Georgia, 30303

United States

Hope Clinic, Emory University (Site 301-031)

Decatur, Georgia, 30030

United States

University of Illinois at Chicago (008-012)

Chicago, Illinois, 60612

United States

Lutheran Medical Group (301-010)

Fort Wayne, Indiana, 46804

United States

University of Kansas Medical Center (Site 080-044)

Kansas City, Kansas, 66160

United States

Massachusetts General Hospital (202-002)

Boston, Massachusetts, 02114

United States

Beth Israel Deaconess Medical Center (202-001)

Boston, Massachusetts, 02215

United States

Lahey Hospital and Medical Center (Site 213-001)

Burlington, Massachusetts, 01805

United States

Baystate Medical Center (Site 201-001)

Springfield, Massachusetts, 01199

United States

University of Massachusetts Chan Medical School (080-007)

Worcester, Massachusetts, 01655

United States

VA Ann Arbor Healthcare System (Site 074-028)

Ann Arbor, Michigan, 48105

United States

University of Michigan Medical Center (205-001)

Ann Arbor, Michigan, 48109

United States

Henry Ford Health System (014-001)

Detroit, Michigan, 48202

United States

Sinai-Grace Hospital (Site 205-005)

Detroit, Michigan, 48235

United States

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

Minneapolis, Minnesota, 55455

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

University of Mississippi Medical Center (Site 202-005)

Jackson, Mississippi, 39216

United States

Washington University School of Medicine (Site 003-001)

St Louis, Missouri, 63310

United States

University of Nebraska Medical Center (Site 080-045)

Omaha, Nebraska, 68198

United States

Dartmouth-Hitchcock Medical Center (301-024)

Lebanon, New Hampshire, 03756

United States

Cooper University Hospital (019-001)

Camden, New Jersey, 08103

United States

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

Newark, New Jersey, 07103

United States

University of New Mexico Hospital (Site 213-008)

Albuquerque, New Mexico, 87106

United States

NYU Brooklyn (301-033)

Brooklyn, New York, 11220

United States

New York Presbyterian Queens (003-005)

Flushing, New York, 11355

United States

NYU Long Island (301-034)

Mineola, New York, 11501

United States

New York University Langone Health (301-013)

New York, New York, 10016

United States

NYC Health + Hospital Harlem (Site 003-003)

New York, New York, 10037

United States

Weill Cornell Clinical Research Unit (065-001)

New York, New York, 10065

United States

Mount Sinai Medical Center (Site 301-012)

New York, New York, 11234

United States

Lincoln Medical Center (Site 003-016)

The Bronx, New York, 10451

United States

James J. Peters VAMC (Site 023-003)

The Bronx, New York, 10468

United States

Duke University Hospital (Site 301-006)

Durham, North Carolina, 27710

United States

Wake Forest Baptist Health (Site 210-001)

Winston-Salem, North Carolina, 27157

United States

Cleveland Clinic Foundation (Site 207-001)

Cleveland, Ohio, 44195

United States

Oregon Health and Science University (208-003)

Portland, Oregon, 97239

United States

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

Hershey, Pennsylvania, 17033

United States

Rhode Island Hospital (Site 080-036)

Providence, Rhode Island, 02903

United States

The Miriam Hospital (Site 080-039)

Providence, Rhode Island, 02906

United States

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

Charleston, South Carolina, 29401

United States

Medical University of South Carolina (Site 210-002)

Charleston, South Carolina, 29425

United States

Vanderbilt University Medical Center (Site 212-001)

Nashville, Tennessee, 37232

United States

Hendrick Medical Center (Site 080-014)

Abilene, Texas, 79602

United States

CHRISTUS Spohn Shoreline Hospital (080-001)

Corpus Christi, Texas, 78404

United States

Parkland Health and Hospital Systems (084-002)

Dallas, Texas, 75235

United States

Baylor, Scott and White Health (301-003)

Dallas, Texas, 75246

United States

UT Southwestern Medical Center (084-001)

Dallas, Texas, 75390

United States

Houston Methodist Research Institute (Site 301-028)

Houston, Texas, 77030

United States

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

Houston, Texas, 77030

United States

UT Health San Antonio (Site 009-022)

San Antonio, Texas, 78229

United States

Intermountain Medical Center (Site 211-001)

Murray, Utah, 84107

United States

University of Utah Hospital (211-002)

Salt Lake City, Utah, 84108

United States

Salem VA Medical Center (Site 074-014)

Salem, Virginia, 24153

United States

Harborview Medical Center (208-001)

Seattle, Washington, 98104

United States

Providence (Sacred Heart) (213-004)

Spokane, Washington, 99204

United States

West Virginia University Medicine (Site 301-023)

Morgantown, West Virginia, 26506

United States

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

Madison, Wisconsin, 53705

United States

Froedtert Memorial Lutheran Hospital (052-001)

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Cavan Reilly, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota
Christina Barkauskas, MD, STUDY_CHAIR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-06

Study Completion Date2025-08-11

Study Record Updates

Study Start Date2023-07-06

Study Completion Date2025-08-11

Terms related to this study

Additional Relevant MeSH Terms

COVID-19