[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559444":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":26,"responsibleParty":44,"collaborators":46,"id":53,"slug":26,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":26,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":26},{"fullName":5,"class":6},"Inova Health Care Services","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"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",[19],"Drug: Fostamatinib",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Placebo","Placebo to be given twice daily for 14 days",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Fostamatinib","Fostamatinib 150mg to be given twice daily for 14 days",[15],[32],"fostamatinib disodium",[34],{"name":35,"affiliation":36,"role":37},"Christopher S. King, MD, FACP","Inova Schar Heart and Vascular","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Edwinia Battle, RN, MSN","CONTACT","(703) 776-3067","edwinia.battle@inova.org",{"type":45,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[47,50],{"name":48,"class":49},"Rigel Pharmaceuticals","INDUSTRY",{"name":51,"class":52},"Biomedical Advanced Research and Development Authority","FED","100559444",false,"NCT06564207","Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults","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)","FOSTA-ARDS","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Subject (or legal representative) provides informed consent to study participation.\n* Subject (or legal representative) understands and agrees to comply with planned study procedures.\n* Hospitalized with acute respiratory failure from ARDS with ratio of partial pressure of arterial oxygen to fraction of inspired oxygen PaO2\u002FFiO2 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.\n* Functional respiratory imaging (FRI) compatible CT scan of the chest within the prior 7 days.\n* Duration of invasive mechanical ventilation \\\u003C 10 days.\n* 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.\n\nExclusion Criteria:\n\n* Severe hepatic impairment (Child-Pugh Class C).\n* Abnormal liver function tests (AST or ALT \\> 3x ULN or AST or ALT \\> 3x ULN)\n* Pregnant or nursing.\n* Participation in any other clinical trial, or receipt of an investigational medicinal product within 30 days prior.\n* Known concomitant life-threatening disease with a life expectancy \\\u003C 6 months.\n* Known hypersensitivity to fostamatinib.\n* Uncontrolled hypertension (Systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n* Neutrophil count \\\u003C 1000\u002FuL\n* Death expected within 72 hours\n* Received a live vaccine in the last 30 days\n* Those who were cognitively impaired or mentally disabled prior to acute illness\n* Patients with acute coronary syndrome, ejection fraction \\\u003C30%, or active unstable arrhythmias","ALL","18 Years",{"count":63,"type":64},40,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).",[70,71],"Acute Respiratory Distress Syndrome","ARDS","NOT_YET_RECRUITING","2026-01-30",{"date":75,"type":76},"2026-02-02","ACTUAL",{"date":78,"type":64},"2026-08-30",{"date":80,"type":64},"2027-10-31",{"name":5,"class":6}]