Using patient blood cells to test whether PIP-2 calms immune activation in ARDS
Official title: Blood-based Biomarkers of Acute Lung Injury/Acute Respiratory Distress Syndrome
Run by University of Pennsylvania · NCT07125079 · Data updated 2026-11-12
This project will test whether a drug called PIP-2 can calm overactive immune cells taken from people with ARDS.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years to 90 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | December 20, 2026 |
| Study ends | November 20, 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07125079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult patients with ARDS (PaO2/FiO2 approximately 100–300 mmHg, covering mild to severe cases) who can provide blood samples and are not pregnant are the intended participants.
✕Probably not a fit
Pregnant people, children, individuals without ARDS, or those unable to give blood are not eligible and would not receive any direct benefit from this in vitro work.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will collect blood from adults with mild to severe ARDS and isolate peripheral blood mononuclear cells (PBMCs). In the laboratory, they will measure immune cell activation and reactive oxygen species production in these patient-derived cells. The isolated cells will be treated in vitro with the experimental agent PIP-2 to see whether it reduces markers of activation and oxidative stress. No investigational drug will be given to patients; all testing is performed on cells in the lab.
Why it matters
Potential benefit: If PIP-2 lowers harmful immune activation in patient cells, it could point to a new treatment approach that reduces immune-driven lung injury in ARDS.
How similar studies have gone: Targeting reactive oxygen species and immune overactivation has shown benefit in animal and laboratory models, but PIP-2 itself is a novel agent not yet tested in patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: ARDS patients with mild and moderate to severe ARDS. This will be based on PaO2/FiO2 in the range of 100 mmHg (severe) and moderate (100-200 mm Hg) and mild (200-300 mm Hg) - Exclusion Criteria: Pregnant women, children will be excluded. \-
Where it's running
-
Hospital Of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Shampa Chatterjee, PhD — University of Pennsylvania
- Study coordinator: Shampa Chatterjee, PhD
- Email: shampac@pennmedicine.upenn.edu
- Phone: 215-898-9101
Similar studies
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In adults with ARDS on mechanical ventilation, the study tests whether a simple manual chest compression method can set the right PEEP as well as electrical impedance tomography (EIT).
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This pilot study tests two personalized PEEP strategies in adults with ARDS to see which approach better supports breathing mechanics by using a recruitment potential measure.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.