Status:
NOT_YET_RECRUITING
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Lead Sponsor:
Inova Health Care Services
Collaborating Sponsors:
Rigel Pharmaceuticals
Biomedical Advanced Research and Development Authority
Conditions:
Acute Respiratory Distress Syndrome
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06564207
Start Date
November 30 2025
End Date
October 31 2026
Last Update
September 17 2025
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