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.

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07125079
Status
Recruiting

Conditions

  • ARDS (Acute Respiratory Distress Syndrome)

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Jun 2026
Primary completion
Dec 20, 2026
Completion
Nov 20, 2027

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: Subjects with ARDS

Primary Outcome Measure

Reactive oxygen species in vitro [ Time Frame: From enrollment until 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital Of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

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