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New drug aims to reduce deaths from severe lung failure

NCT ID NCT05947955

Disease control Sponsor: BioAegis Therapeutics Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This study tests an experimental drug called recombinant human plasma gelsolin (rhu-pGSN) added to standard care for people with moderate-to-severe acute respiratory distress syndrome (ARDS) caused by pneumonia or other infections. About 600 hospitalized adults will receive either the drug or a placebo, and researchers will measure how many survive at 28 days, how many days they need a ventilator, and other outcomes. The goal is to see if this drug can improve survival and recovery.

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

Oct 2024

Expected to finish

Mar 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: 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist * Investigator or designee to note radiologic findings in the electronic case report form (eCRF) * Radiology report and conclusion should be summarized in the eCRF * A digital copy of the radiograph uploaded and saved for review 2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria. 3. Age ≥18 years 4. Informed consent obtained from subject/next of kin/legal proxy 5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team 6. During the course of the study starting at screening and for at least 3 months after their final study treatment: 1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods 2. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner 3. All subjects must agree not to donate sperm or eggs Exclusion Criteria: 1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload. 2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection 3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO) 4. Pregnant or lactating women 5. Previous splenectomy 6. Any vaccination in the previous 30 days 7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days 8. Known allergy to study drug or excipients 9. Weight \>125 kg 10. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months 11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease 12. Chronic mechanical ventilation or dialysis 13. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy \<6 months unrelated to acute infection in the opinion of the Investigator.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Infections infectious disease respiratory failure

As listed by the trial registrant

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

Acute respiratory distress syndrome Infections

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    70 sites in 13 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Asst-Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Baylor Scott & White Health

    RECRUITING

    Temple, Texas, 76508, United States

  • Bellvitge University Hospital

    RECRUITING

    Barcelona, 08907, Spain

  • Bryan Medical Center

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • CHU Charleroi Marie Curie Hospital

    RECRUITING

    Charleroi, 6042, Belgium

  • CHU Nantes

    RECRUITING

    Nantes, 1, France

  • Canisius Wilhelmina Ziekenhuis

    RECRUITING

    Nijmegen, 6532 SZ, Netherlands

    Contact Email: •••••@•••••

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Departemental (CHD) Vendee

    RECRUITING

    La Roche-sur-Yon, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Oullins-Pierre-Bénite, 69495, France

  • Centre Hospitalier Regional de la Citadelle

    RECRUITING

    Liège, 4000, Belgium

  • Centre Hospitalier de Melun-Senart

    RECRUITING

    Melun, 77000, France

  • Centre intégré universitaire de santé et services sociaux du nord de l'île de Montréal-Hôpital du Sacré de Montréal (CIUSSS-NÎM-HSCM)

    RECRUITING

    Montreal, Quebec, H4J1C5, Canada

  • Clinical County Hospital Timisoara

    RECRUITING

    Timișoara, 300723, Romania

  • Clinique Saint-Pierre Ottignies

    RECRUITING

    Ottignies, 1340, Belgium

  • Clínico San Carlos

    RECRUITING

    Madrid, Spain

  • County Clinical Hospital Tirgu Mures

    RECRUITING

    Târgu Mureş, 540103, Romania

  • Derriford Hospital (University Hospitals Plymouth Hospital Trust)

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Ferenc Csolnoky Hospital of Veszprem County

    RECRUITING

    Veszprém, H-8200, Hungary

  • Fondazione Policlinico A. Gemelli IRCCS

    RECRUITING

    Rome, 00165, Italy

  • Foothills Medical Centre

    RECRUITING

    Calgary, Alberta, AB T2N 5A1, Canada

  • Gelderse Vallei Hospital

    RECRUITING

    Ede, Netherlands

  • Gelre Hospitals, Department of ICU

    RECRUITING

    Apeldoorn, Netherlands

  • General University Hospital

    RECRUITING

    Prague, 2, 12000, Czechia

  • Grey Nuns Hospital

    RECRUITING

    Edmonton, Alberta, T6L 5X8, Canada

  • HUB - Hôpital Erasme

    RECRUITING

    Brussels, 1070, Belgium

  • Hannibal Regional Hospital

    RECRUITING

    Hannibal, Missouri, 63401, United States

  • Hopital Pitie-Salpetriere

    RECRUITING

    Paris, 75013, France

  • Hospital Clínic Barcelona

    RECRUITING

    Barcelona, 08030, Spain

  • Hospital Universitari Sant Joan de Reus

    RECRUITING

    Tarragona, 43204, Spain

  • Hospital Universitari de Tarragona Joan XXIII

    RECRUITING

    Tarragona, 43005, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario de Getafe

    RECRUITING

    Madrid, 28905, Spain

  • Hospital of Siofok

    RECRUITING

    Siófok, 8600, Hungary

  • Hôpital du Kremlin Bicêtre, APHP

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • Jena University Hospital

    RECRUITING

    Jena, 07747, Germany

  • Jeroen Bosch Ziekenhuis

    RECRUITING

    's-Hertogenbosch, Netherlands

  • Lions Gate Hospital

    RECRUITING

    North Vancouver, British Columbia, V7L 2L7, Canada

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH)

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, 7512 KZ, Netherlands

  • National Institute of Pulmonology

    RECRUITING

    Budapest, H-1121, Hungary

  • New York University Grossman School of Medicine

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Northwestern University - Pulmonary and Critical Care Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Nouvel Hopital Civil

    NOT_YET_RECRUITING

    Strasbourg, 67091, France

  • Penn State Health - Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Penn State Health - Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Peter Lougheed Centre

    RECRUITING

    Calgary, T1Y 6J4, Canada

  • Pinderfields Hospital (Mid Yorkshire Teaching NHS Trust)

    RECRUITING

    Wakefield, WF1 4DG, United Kingdom

  • Rocky View General Hospital

    RECRUITING

    Calgary, T2V 1P9, Canada

  • Saarland University Hospital

    RECRUITING

    Homburg, 66421, Germany

  • South Health Campus

    RECRUITING

    Calgary, T3M 1M4, Canada

  • Spital Universitar de Urgenta ELIAS (University Emergency Hospital Elias)

    RECRUITING

    Bucharest, Romania

  • St. Anne's University Hospital

    RECRUITING

    Brno, 602 00, Czechia

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Szabolcs-Szatmar-Bereg County Teaching Hospital, Andras Josa Hospital

    RECRUITING

    Nyíregyháza, H-4400, Hungary

  • Szent Damján Greek Catholic Hospital

    RECRUITING

    Kisvárda, 4600, Hungary

  • Tenon Hospital

    RECRUITING

    Paris, 75020, France

  • UMHAT "Alexandrovska" EAD

    RECRUITING

    Sofia, Bulgaria

  • University Health Network (UHN)-Toronto General Hospital (TGH)

    RECRUITING

    Toronto, Ontario, M5G 2N2, Canada

  • University Hospital Královské Vinohrady

    RECRUITING

    Prague, 100 34 10, Czechia

  • University Hospital LMU Munich

    RECRUITING

    Munich, D-81377, Germany

  • University Hospital of Bucharest

    RECRUITING

    Bucharest, 050098, Romania

  • University Hospital of Bucharest

    RECRUITING

    Barcelona, 08208, Spain

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • University of Louisville Hospital - Jewish Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Louisville-Jewish Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15261, United States

  • Wellstar MCG Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

More trials for these conditions

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