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Can a single antibody turn down the immune storm in ARDS?

NCT ID NCT06513949

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This trial tests whether an antibody called IC14 can reduce dangerous lung inflammation in people with acute respiratory distress syndrome (ARDS), a severe condition where the lungs fill with fluid. Hospitalized patients on a ventilator receive either IC14 or a placebo, and researchers measure oxygen levels and markers of inflammation over 28 days. The goal is to see if blocking a protein called CD14 can calm the immune system and improve breathing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a monoclonal antibody called atibuclimab (IC14) that blocks CD14 to reduce inflammation
What this could lead to
If effective, IC14 could offer a new way to treat acute respiratory distress syndrome by calming the immune system's overreaction in the lungs.
What could go wrong
This is an early Phase 2 trial with only 56 participants, so results may not apply broadly. Blocking CD14 could also impair the body's ability to fight infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients may be included in the study only if they meet all the following criteria: 1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours) 1. P:F ratio \< 300 2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O 3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar/lung collapse, or nodules 4. Respiratory failure not fully explained by cardiac failure or fluid overload 5. Within 1 week of known clinical insult or new or worsening respiratory symptoms i. Common Risk Factors for ARDS: Pneumonia, aspiration, inhalation injury, pulmonary contusion, pulmonary vasculitis, drowning, non-pulmonary sepsis, major trauma, pancreatitis, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions 2. Patient or Legal authorized representative able to understand and give written informed consent Exclusion Criteria: An individual fulfilling any of the following criteria should be excluded from enrollment in the study: 1. Significant pre-existing organ dysfunction prior to hospitalization 1. Lung: Currently receiving home oxygen therapy as documented in medical record 2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record 3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \<30 mL/min. 4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \>5 times upper limit of normal 5. Hematologic: Baseline platelet count \<50,000/mm3 2. Presence of co-existing infection, including, but not limited to: 1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm3 2. Active tuberculosis or a history of inadequately treated tuberculosis 3. Active hepatitis B or hepatitis C viral infection 3. Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments 4. Receiving comfort measures only 5. Requiring \>2 vasopressors 6. Pregnant 7. Prisoners 8. History of hypersensitivity or idiosyncratic reaction to IC14 9. Women who are currently breastfeeding 10. Bronchoscopy safety exclusions 1. P:F \<100 on 100% FiO2 2. Mean pulmonary artery pressure \> 55 mmHg 3. Marked cardiovascular instability (Mean arterial pressure \<55 mmHg with vasopressor support) 4. Intracranial pressure ≥20 mmHg 5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction) 6. Supported on extracorporeal membrane oxygenation 7. Endotracheal tube \<6.5 mm

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

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