drugset / Trial / NCT05822583

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

NCT05822583

Phase 4 Completed 285 enrolled University of Minnesota
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-07-06
Primary completion
2025-06-21
Completion
2025-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 10 mg/kg Intravenous

Indications