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Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT05822583•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•Investigator agrees that the pneumonia is due to COVID-19.
•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).
+9 more criteria

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.)

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

Key Dates

Start Date

July 6, 2023

Primary Completion Date

June 21, 2025

Completion Date

August 11, 2025

Last Updated

September 4, 2025

Enrollment

285

ACTUAL participants

Conditions

COVID-19

Interventions

abatacept infusion

DRUG

Placebo group

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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