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New drug trial aims to boost survival in severe lung failure patients

NCT ID NCT06701682

Disease control Sponsor: PPD Development, LP Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests a medicine called vilobelimab in adults hospitalized with moderate to severe acute respiratory distress syndrome (ARDS), a life-threatening lung condition. About 200 participants will receive either the drug or a placebo to see if it improves survival and is safe. The main goal is to measure how many patients are alive 28 days after treatment.

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 200 people

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

Started

Jun 2025

Expected to finish

Sep 2028

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: The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073. * ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073. * Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome Acute respiratory distress syndrome (ARDS) ARDS ARDS (acute respiratory distress syndrome)

How to take part

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

  1. The places running it

    40 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

  • Baylor All Saints Medical Center

    RECRUITING

    Fort Worth, Texas, 76104-4110, United States

  • Baylor St Luke's Medical Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030-4202, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Community Regional Medical Center

    RECRUITING

    Fresno, California, 93721-1324, United States

  • Denver Health Hospital and Authority

    RECRUITING

    Denver, Colorado, 80204-4532, United States

  • Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710-4000, United States

  • Durham VA Medical Center

    RECRUITING

    Durham, North Carolina, 27705-3875, United States

  • Henry Ford Health Hospital

    RECRUITING

    Detroit, Michigan, 48202-2608, United States

  • Houston Methodist Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107-5701, United States

  • Lahey Hospital and Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805-0001, United States

  • Long Beach Memorial Medical Center

    RECRUITING

    Long Beach, California, 90806-1701, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010-3017, United States

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425-8908, United States

  • Memorial Sloan Kettering Cancer Center

    NOT_YET_RECRUITING

    New York, New York, 10065-6007, United States

  • Mercy Health - St. Vincent Medical Center

    RECRUITING

    Toledo, Ohio, 43608-2603, United States

  • Montefiore Hospital - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • North Florida / South Georgia Veterans Health System

    RECRUITING

    Gainesville, Florida, 32608-1135, United States

  • Northshore University Healthsystem Research Institute

    NOT_YET_RECRUITING

    Evanston, Illinois, 60201-1700, United States

  • Nova Clinical Research

    RECRUITING

    Bradenton, Florida, 34209-4617, United States

  • OSF Saint Francis Medical Center-

    RECRUITING

    Peoria, Illinois, 61637-0001, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239-3011, United States

  • Renown Institute for Heart & Vascular Health

    WITHDRAWN

    Reno, Nevada, 89502-1576, United States

  • Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901-1928, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • St. Luke's Boise Medical Center

    RECRUITING

    Boise, Idaho, 83712-6241, United States

  • Stanford Medical Center

    RECRUITING

    Stanford, California, 94305-2200, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122-4379, United States

  • The University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104-3609, United States

  • Tufts Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02111, United States

  • University Hospitals Cleveland Medical Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106-1716, United States

  • University of Alabama Hospital

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233-1932, United States

  • University of California Davis Medical Center - Pulmonary Medicine

    RECRUITING

    Sacramento, California, 95816-4300, United States

  • University of California Irvine Medical Center

    RECRUITING

    Orange, California, 92868-3201, United States

  • University of Michigan Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599-0001, United States

  • University of Virginia Health System

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22908-0816, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232-0004, United States

  • Weill Cornell Medical College

    NOT_YET_RECRUITING

    New York, New York, 10065-8722, United States

  • Westchester Medical Center

    NOT_YET_RECRUITING

    Valhalla, New York, 10595-1530, United States

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