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

Phase 2

Not yet recruiting

• Conditions: Acute Respiratory Distress Syndrome; ARDS
• Interventions: Drug: Placebo; Drug: Fostamatinib

• Registration Number: NCT06564207
• Lead Sponsor: Inova Health Care Services

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 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 Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Study Start: 2025-05-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥ 18 years old.
• Subject (or legal representative) provides informed consent to study participation.
• Subject (or legal representative) understands and agrees to comply with planned study procedures.
• Hospitalized with acute respiratory failure from ARDS with ratio of partial pressure of arterial oxygen to fraction of inspired oxygen PaO2/FiO2 of 200 mm of Hg or less with positive end expiratory pressure (PEEP) equal to or higher than 5 cm of H2O and requiring invasive mechanical ventilation or extracorporeal support.
• Functional respiratory imaging (FRI) compatible CT scan of the chest within the prior 7 days.
• Duration of invasive mechanical ventilation < 10 days.
• Females of childbearing potential must agree to be abstinent or seek a highly effective form of contraception from the time of enrollment through 30 days after the last day of study drug.

Exclusion Criteria

• Severe hepatic impairment (Child-Pugh Class C).
• Abnormal liver function tests (AST or ALT > 3x ULN or AST or ALT > 3x ULN)
• Pregnant or nursing.
• Participation in any other clinical trial, or receipt of an investigational medicinal product within 30 days prior.
• Known concomitant life-threatening disease with a life expectancy < 6 months.
• Known hypersensitivity to fostamatinib.
• Uncontrolled hypertension (Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
• Neutrophil count < 1000/uL
• Death expected within 72 hours
• Received a live vaccine in the last 30 days
• Those who were cognitively impaired or mentally disabled prior to acute illness
• Patients with acute coronary syndrome, ejection fraction <30%, or active unstable arrhythmias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cumulative Incidence of Serious Adverse Events (SAEs) Through Day 30	Up to 30 days post-intervention	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)