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New hope for ARDS: major trial tests multiple therapies in hospitalized patients

NCT ID NCT06703073

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 several experimental treatments for adults hospitalized with acute respiratory distress syndrome (ARDS), a severe lung condition. About 600 participants will receive either a placebo or an active drug to see if the treatments improve survival and are safe. The goal is to find better ways to control this life-threatening illness.

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 600 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 Each participant must meet all of the following criteria to be enrolled in this study: * Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements * Participant is at least 18 years of age or older at the time of consent. * Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS. Note that participants on noninvasive ventilation may be screened. * Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply * Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90). Exclusion Criteria Participants will be excluded from the study if any of the following apply: * Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion. * Participant with pulmonary edema due to cardiogenic pulmonary edema/fluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS. * Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions. * Participant is known to be pregnant, nursing, or with a positive (urine and/or serum test) pregnancy test. * Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours. * Participant is not expected to survive for 72 hours. * Participant has been on invasive mechanical ventilation or ECMO for ARDS for more than 48 hours for ARDS at the time of consent. * Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation * Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing. * Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy. * Participant has NY Heart Association Class IV congestive heart failure. * Participant has a known allergy to any study medication or any of its excipients. * Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication therapy OR systemic immunosuppressive corticosteroids (prednisone ≥20 mg daily or equivalent). NOTE: Patients onreceiving chronic low dose immunosuppressive therapy may be enrolled(e.g., prednisone \<20 mg/day or equivalent) and patients on stable, long-term maintenance immunosuppression (e.g., tacrolimus, mycophenolate, orsirolimus) and patients receiving physiologic replacement and hormonal therapies for breast cancer (e.g., tamoxifen, letrozole) or prostate cancer (leuprolide, bicalutamide) for \>60 days may be eligible at the investigator's discretion of the investigator in consultation with the medical monitor. * Participant is receiving ongoing cytotoxic chemotherapy (IV or oral), OR combination targeted/immunotherapy regimens for cancer within the past 60 days. Note: Participants receiving non-myelosuppressive cancer therapy (e.g., hormonal therapy or selected targeted / immunotherapy regimens) may be eligible if therapy has been stable ≥60 days; The use of hydroxyurea to manage patients with chronic myeloid leukemia, polycythemia vera, essential thrombocythemia or sickle cell disease is permitted. * Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization. * Participant with concurrent infections or history of the following: 1. Known active tuberculosis, 2. Known active Hepatitis B, or 3. HIV and a CD4 count less than 50 or a detectable viral load of \>200 copies/mL HIV RNA. * Participant received treatment with any other investigational drugs within 30 days prior to consent. * Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening. * Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. Participant may have additional cohort-specific requirements.

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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

    NOT_YET_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

More trials for these conditions

Other studies related to the condition(s) this trial covers.