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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome; ARDS
• Intervention / Treatment: Drug: Placebo; Drug: Fostamatinib

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Edwinia Battle, RN, MSN; Phone Number: (703) 776-3067; Email: edwinia.battle@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Placebo; Placebo to be 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	Drug: Fostamatinib; Fostamatinib 150mg to be given twice daily for 14 days; Other Names: fostamatinib disodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 30 days post-intervention

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: Biomedical Advanced Research and Development Authority; Rigel Pharmaceuticals
• Investigators: Principal Investigator: Christopher S. King, MD, FACP, Inova Schar Heart and Vascular

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome; Substandard Drugs; Pharmaceutical Preparations; fostamatinib
• Other Study ID Numbers: INOVA-2023-169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No