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

Sponsor
Inova Health Care Services
Study ID
NCT06564207
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • ARDS
  • Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo to be given twice daily for 14 days
  • Fostamatinib — DRUG
    Fostamatinib 150mg to be given twice daily for 14 days

Study Details

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

Key Dates

Start date
Aug 30, 2026
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Standard of Care (SOC) + Placebo (BID for 14 Days)
    Participants randomized to this arm will receive standard of care (SOC) treatment plus placebo given twice daily for 14 days
  • Experimental: Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days)
    Participants randomized to this arm will receive standard of care (SOC) treatment plus fostamatinib 150mg given twice daily for 14 days

Primary Outcome Measure

Cumulative Incidence of Serious Adverse Events (SAEs) Through Day 30 [ Time Frame: Up to 30 days post-intervention ]

Central Contacts

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