Clinical Trial

Lung Injury is One of the Primary Causes of Morbidity and Mortality in Critically Ill Patients. These Patients Will be Monitored for: 1) Immune Cell Activation 2) Blood-based Biomarkers. In Vitro Models Derived From These Samples Will be Treated With Novel Agent PIP-2 to Evaluate Its Efficacy.

Study acronym: ALI/ARDS
Recruiting
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Summary
Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) is a condition where high levels of inflammation damage the lung. This is a highly morbid condition with no specific pharmacologic therapies. The investigators posit that ARDS is caused due to an exaggerated activation of immune cells and that blockade of this activation may reduce lung damage/injury and help in ARDS management and possibly recovery. To test this hypothesis, the investigators propose to generate an in vitro immune cell model and test a novel (reactive oxygen species) blocking agent PIP-2 on this model. The investigating team will obtain blood of ARDS patients and isolate immune cells (specifically peripheral blood mononuclear cells or PBMC) and monitor the activation of these cells and their blockade by PIP-2. This is entirely an in vitro study.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-07.
Trial Details
NCT Number NCT07125079
Lead Sponsor University of Pennsylvania
Collaborators: Peroxitech Inc
Conditions ARDS (Acute Respiratory Distress Syndrome)
Enrollment 36 participants
Start Date 2025-05-20
Primary Completion 2026-12-20 (estimated)
Study Completion 2027-11-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-10