Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services
About this trial
This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Placebo
- Fostamatinib
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Inova Health Care Services
Lead sponsor
Rigel Pharmaceuticals
Collaborator
Biomedical Advanced Research and Development Authority
Collaborator
Source ClinicalTrials.gov