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

NCT05822583 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2025-09-04

No results posted yet for this study

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

Interventions

DRUG

abatacept infusion

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)

DRUG

Placebo group

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

Sponsors & Collaborators

Principal Investigators

  • Cavan Reilly, PhD · University of Minnesota

  • Christina Barkauskas, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2025-06-21
Completion
2025-08-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Georgia
  • Germany
  • Greece
  • India
  • Ireland
  • Nigeria
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822583 on ClinicalTrials.gov