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.

NCT ID: NCT07125079

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2026-11-20

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.

Detailed Description

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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with ARDS

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peroxitech Inc

UNKNOWN

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shampa Chatterjee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Christian Bermudez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Asad Usman, MD

Role: STUDY_DIRECTOR

University of Pennsylvania

Locations

Hospital Of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shampa Chatterjee, PhD

Role: CONTACT

shampac@pennmedicine.upenn.edu

215-898-9101

Christian Bermudez, MD

Role: CONTACT

christian.bermudez@pennmedicine.upenn.edu

215-615-5864

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Biomarkers of Lung Injury

Identifier Type: -

Identifier Source: org_study_id