NCT07199192

Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial

A Multicenter, Randomized, Controlled Trial to Evaluate the Effectiveness and Safety of Systemic Corticosteroid Treatment for Hospitalized Patients With Severe Acute Respiratory Infection and Hypoxemia (STRIVE 003)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, parallel-group, randomized clinical trial comparing the administration of systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days vs no corticosteroid administration among adults hospitalized with severe acute respiratory infection and hypoxemia.

Conditions

• Hypoxemia
• Severe Acute Respiratory Syndrome

Interventions

Type	Name	Description
DRUG	Corticosteroid	systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-30
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study