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RECRUITING

NCT05947955

PHASE2

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Sponsor: BioAegis Therapeutics Inc.

View on ClinicalTrials.gov

Summary

BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.

Official title: A Phase 2 Randomized Double-blind Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Care For Moderate-to-Severe ARDS Due To Pneumonia Or Other Infections

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-10-03

Completion Date

2027-03-01

Last Updated

2026-01-14

Healthy Volunteers

Conditions

Acute Respiratory Distress Syndrome Infections

Interventions

DRUG

Rhu-pGSN

Intravenous administration based on actual body weight

DRUG

normal saline

intravenous administration in the same volume as the active therapy

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.

Locations (76)

University of California Irvine Medical Center

Irvine, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Wellstar MCG Augusta University

Augusta, Georgia, United States

Northwestern University - Pulmonary and Critical Care Medicine

Chicago, Illinois, United States

University of Louisville Hospital - Jewish Hospital

Louisville, Kentucky, United States

University of Louisville-Jewish Hospital

Louisville, Kentucky, United States

Mayo Clinic

Rochester, Minnesota, United States

Hannibal Regional Hospital

Hannibal, Missouri, United States

Bryan Medical Center

Lincoln, Nebraska, United States

New York University Grossman School of Medicine

New York, New York, United States

Penn State Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Penn State Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

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

Houston, Texas, United States

Baylor Scott & White Health

Temple, Texas, United States

HUB - Hôpital Erasme

Brussels, Belgium

CHU Charleroi Marie Curie Hospital

Charleroi, Belgium

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Clinique Saint-Pierre Ottignies

Ottignies, Belgium

Acibadem City Clinic UMHAT Tokuda - Sofia

Sofia, Bulgaria

Military Medical Academy

Sofia, Bulgaria

UMHAT "Alexandrovska" EAD

Sofia, Bulgaria

Foothills Medical Centre

Calgary, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Grey Nuns Hospital

Edmonton, Alberta, Canada

Lions Gate Hospital

North Vancouver, British Columbia, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

Peter Lougheed Centre

Calgary, Canada

Rocky View General Hospital

Calgary, Canada

South Health Campus

Calgary, Canada

St. Anne's University Hospital

Brno, Czechia

University Hospital Královské Vinohrady

Prague, Czechia

General University Hospital

Prague, Czechia

Centre Hospitalier Departemental (CHD) Vendee

La Roche-sur-Yon, France

Hôpital du Kremlin Bicêtre, APHP

Le Kremlin-Bicêtre, France

Centre Hospitalier de Melun-Senart

Melun, France

CHU Nantes

Nantes, France

Centre Hospitalier Lyon Sud

Oullins-Pierre-Bénite, France

Hopital Pitie-Salpetriere

Paris, France

Tenon Hospital

Paris, France

Nouvel Hopital Civil

Strasbourg, France

Saarland University Hospital

Homburg, Germany

Jena University Hospital

Jena, Germany

University Hospital LMU Munich

Munich, Germany

National Institute of Pulmonology

Budapest, Hungary

Petz Aladár University Teaching Hospital

Győr, Hungary

Szent Damján Greek Catholic Hospital

Kisvárda, Hungary

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

Nyíregyháza, Hungary

Hospital of Siofok

Siófok, Hungary

Teaching Hospital of Vas County

Szombathely, Hungary

Ferenc Csolnoky Hospital of Veszprem County

Veszprém, Hungary

Asst-Spedali Civili di Brescia

Brescia, Italy

Fondazione Policlinico A. Gemelli IRCCS

Rome, Italy

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Gelre Hospitals, Department of ICU

Apeldoorn, Netherlands

Gelderse Vallei Hospital

Ede, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

University Hospital of Bucharest

Bucharest, Romania

Spital Universitar de Urgenta ELIAS (University Emergency Hospital Elias)

Bucharest, Romania

County Clinical Hospital Tirgu Mures

Târgu Mureş, Romania

Clinical County Hospital Timisoara

Timișoara, Romania

Hospital Clínic Barcelona

Barcelona, Spain

University Hospital of Bucharest

Barcelona, Spain

Bellvitge University Hospital

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario de Getafe

Madrid, Spain

Clínico San Carlos

Madrid, Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

Hospital Universitari Sant Joan de Reus

Tarragona, Spain

University Hospital of Wales

Cardiff, United Kingdom

Derriford Hospital (University Hospitals Plymouth Hospital Trust)

Plymouth, United Kingdom

Pinderfields Hospital (Mid Yorkshire Teaching NHS Trust)

Wakefield, United Kingdom

Clinical Research Directory

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (76)