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

NCT06564207 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: INOVA-2023-169
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome; ARDS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care (SOC) + Placebo (BID for 14 Days)

PLACEBO COMPARATOR

Participants randomized to this arm will receive standard of care (SOC) treatment plus placebo given twice daily for 14 days

Drug: Placebo

Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days)

EXPERIMENTAL

Participants randomized to this arm will receive standard of care (SOC) treatment plus fostamatinib 150mg given twice daily for 14 days

Drug: Fostamatinib

Interventions

Placebo DRUG

Placebo to be given twice daily for 14 days

Standard of Care (SOC) + Placebo (BID for 14 Days)

Fostamatinib DRUG

Fostamatinib 150mg to be given twice daily for 14 days

Also known as: fostamatinib disodium

Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead
• Rigel Pharmaceuticals: collaborator
• Biomedical Advanced Research and Development Authority: collaborator

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Christopher S. King, MD, FACP

  Inova Schar Heart and Vascular

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwinia Battle, RN, MSN

CONTACT

(703) 776-3067; edwinia.battle@inova.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to receive either fostamatinib plus standard of care or placebo plus standard of care.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share