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

Launched by INOVA HEALTH CARE SERVICES · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called fostamatinib to see if it is safe and effective for treating adults who are hospitalized with Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition where the lungs can't get enough oxygen into the blood, and patients often need help with breathing through machines. The trial is looking for participants who are at least 18 years old and are currently receiving invasive mechanical ventilation due to ARDS. To qualify, they must have certain health conditions and must not have severe liver disease or other serious health issues that could affect their participation.

If someone is eligible and decides to join the trial, they can expect to receive the study medication while being closely monitored by healthcare professionals. The trial is in its early stages, and it has not started recruiting participants yet, so interested individuals should stay informed for when it begins. It’s important for potential participants to understand the study procedures and follow instructions, especially regarding birth control if they are women who can become pregnant. Overall, this trial aims to find out if fostamatinib can improve outcomes for patients with ARDS.

Gender

ALL

Eligibility criteria

• 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