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OpenTrials
Recruiting

NCT Number: NCT07125079

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.

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.

Recruiting

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

About this study

The research study is being conducted to understand the behavior of immune cells in a patient with Acute Respiratory Distress Syndrome (ARDS). Immune cells protect humans from external threats like infection. However, if these cells are overactive, they can lead to an infection progressing into ARDS. ARDS arises as a result of extensive damage possibly due to overactivated immune cells. This project aims to understand the link between immune cell activation and ARDS.

To do so, the investigators will isolate immune cells specifically peripheral blood mononuclear cells (PBMC) from blood of ARDS patients. These cells will be utilized for in vitro experiments by checking for overactivation. Cells in vitro will also be treated with a novel synthetic agent PIP-2 (being developed Peroxitech Inc. a Collaborator of this study) to check if PIP-2 can reduce overactivation as monitored by the production of reactive oxygen species.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. Reactive oxygen species in vitro

    Time frame: From enrollment until 21 days

    Peripheral Blood Mononuclear cells (PBMC) isolated

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Bermudez, MD

CONTACT

[email protected]

215-615-5864

Shampa Chatterjee, PhD

CONTACT

[email protected]

215-898-9101

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Peroxitech Inc

Registry information

Official study title

Blood-based Biomarkers of Acute Lung Injury/Acute Respiratory Distress Syndrome

Acronym: ALI/ARDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 15, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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