Recruiting

PIP-2

Sponsor:

University of Pennsylvania

Code:

NCT07125079

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Study ID

NCT07125079

Start date

May 20, 2025

Status verified date

Jun, 2026

Completion date

Nov 20, 2027

Anticipated

Primary completion date

Dec 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

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Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects with ARDS

Primary outcome measure

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

Central Contacts and Locations

Locations

Hospital Of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

University of Pennsylvania

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • ROS
  • ARDS
  • PIP-2
  • immune cells
  • peripheral blood mononuclear cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-06-10.