NCT06564207

Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults

Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study for the Long Term Evaluation of Fostamatinib for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome (ARDS)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).

Detailed description

This is a randomized, double-blind, placebo-controlled phase 2 study for long-term evaluation of fostamatinib for the treatment of adult patients with acute respiratory distress syndrome. Subjects will be randomly assigned 1:1 to either standard of care treatment plus fostamatinib or standard or care plus placebo. Th study drug will be taken twice daily for 14 days. The primary objective will be to evaluate drug safety in hospitalized patients with severe ARDS. Other objectives include assessment of the efficacy and clinically relevant endpoints, such as mortality and effects on resolution of this disease entity. The ability of fostamatinib to impact the short term and long term outcomes for patients with ARDS will be directly evaluated.

Conditions

• Acute Respiratory Distress Syndrome
• ARDS

Interventions

Type	Name	Description
DRUG	Placebo	Placebo to be given twice daily for 14 days
DRUG	Fostamatinib	Fostamatinib 150mg to be given twice daily for 14 days

Timeline

• Start date: 2026-08-30
• Primary completion: 2027-05-31
• Completion: 2027-10-31
• First posted: 2024-08-21
• Last updated: 2026-02-02

Regulatory

• FDA-regulated drug study