ARDS (Acute Respiratory Distress Syndrome)ALI/ARDSNCT07125079
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.
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 20 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Hospital Of the University of Pennsylvania at the ICU.
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital Of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Blood-based Biomarkers of Acute Lung Injury/Acute Respiratory Distress Syndrome
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.
Read the 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.
- Keywords
- ROS, ARDS, PIP-2, immune cells, peripheral blood mononuclear cells
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with ARDS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive oxygen species in vitro
Peripheral Blood Mononuclear cells (PBMC) isolated
Measured: From enrollment until 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 May 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Peroxitech Inc
- Responsible party
- Sponsor
- Investigators
- Shampa Chatterjee, PhD, Principal investigator, University of PennsylvaniaChristian Bermudez, MD, Principal investigator, University of PennsylvaniaAsad Usman, MD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125079
- Sponsor's protocol ID
- Biomarkers of Lung Injury
- Acronym
- ALI/ARDS
- Status last verified
- Jun 2026
- First submitted
- 30 May 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-based Biomarkers of Acute Lung Injury/Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07125079
- Acronym / sponsor ID
- ALI/ARDS / Biomarkers of Lung Injury
- Keywords
- ROS, ARDS, PIP-2, immune cells, peripheral blood mononuclear cells
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Peroxitech Inc
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with ARDS | – | – |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Hospital Of the University of Pennsylvania at the ICU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reactive oxygen species in vitro
Time frame: From enrollment until 21 days
Peripheral Blood Mononuclear cells (PBMC) isolated
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shampa Chatterjee, PhD principal investigator
University of Pennsylvania
Christian Bermudez, MD principal investigator
University of Pennsylvania
Asad Usman, MD study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shampa Chatterjee, PhD (215-898-9101, shampac@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive oxygen species in vitro (time frame: From enrollment until 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.