Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564207
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Fostamatinib for Treating Acute Respiratory Distress Syndrome ARDS in Hospitalized Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOSTA-ARDS
Brief 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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None