This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Placebo to be given twice daily for 14 days
Fostamatinib 150mg to be given twice daily for 14 days
Cumulative Incidence of Serious Adverse Events (SAEs) Through Day 30
The cumulative incidence of serious adverse events (SAEs) occurring through day 30 following the intervention. An SAE is defined by the International Conference on Harmonization (ICH) guidelines as any adverse event fulfilling at least one of the following criteria: Results in death; Is life threatening; Requires in-subject hospitalization or prolongation of an existing hospitalization; Results in persistent or significant disability/incapacity; Is considered an important medical event (or medically significant)
Time frame: Up to 30 days post-intervention
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