NCT05822583

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-06-21
• Completion: 2025-08-11
• First posted: 2023-04-21
• Last updated: 2025-09-04

Locations

127 sites across 19 countries: United States, Australia, Denmark, France, Georgia, Germany, Greece, India, Ireland, Nigeria, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study