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Clinical Trials in the UK / NCT05947955
Recruiting Phase 2

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

NCT05947955 · tracked via the Priya Life Science UK tracker
Sponsor
BioAegis Therapeutics Inc.
Phase
Phase 2
Started
2024-10-03
Last updated
2026-09-10

Condition(s) studied

Acute Respiratory Distress SyndromeInfections

Investigational drug(s) / intervention(s)

Rhu-pGSNnormal saline

Rhu-pGSN: Intravenous administration based on actual body weight

normal saline: intravenous administration in the same volume as the active therapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California Recruiting
Wellstar MCG Augusta University Augusta Georgia Recruiting
Northwestern University - Pulmonary and Critical Care Medicine Chicago Illinois Recruiting
University of Louisville Hospital - Jewish Hospital Louisville Kentucky Recruiting
University of Louisville-Jewish Hospital Louisville Kentucky Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Hannibal Regional Hospital Hannibal Missouri Recruiting
Bryan Medical Center Lincoln Nebraska Recruiting
New York University Grossman School of Medicine New York New York Not Yet Recruiting
Penn State Health - Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
Penn State Health - Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center Houston Texas Recruiting
Baylor Scott & White Health Temple Texas Recruiting
HUB - Hôpital Erasme Brussels Belgium Recruiting
CHU Charleroi Marie Curie Hospital Charleroi Belgium Recruiting
Centre Hospitalier Regional de la Citadelle Liège Belgium Recruiting
Clinique Saint-Pierre Ottignies Ottignies Belgium Recruiting
UMHAT "Alexandrovska" EAD Sofia Bulgaria Recruiting
Foothills Medical Centre Calgary Alberta Recruiting
Grey Nuns Hospital Edmonton Alberta Recruiting
Lions Gate Hospital North Vancouver British Columbia Recruiting
Sunnybrook Health Sciences Centre Toronto Ontario Recruiting
University Health Network (UHN)-Toronto General Hospital (TGH) Toronto Ontario Recruiting
McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH) Montreal Quebec Recruiting
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 Recruiting
Peter Lougheed Centre Calgary Canada Recruiting
Rocky View General Hospital Calgary Canada Recruiting
South Health Campus Calgary Canada Recruiting
St. Anne's University Hospital Brno Czechia Recruiting
University Hospital Královské Vinohrady Prague Czechia Recruiting
General University Hospital Prague Czechia Recruiting
Centre Hospitalier Departemental (CHD) Vendee La Roche-sur-Yon France Recruiting
Hôpital du Kremlin Bicêtre, APHP Le Kremlin-Bicêtre France Recruiting
Centre Hospitalier de Melun-Senart Melun France Recruiting
CHU Nantes Nantes France Recruiting
Centre Hospitalier Lyon Sud Oullins-Pierre-Bénite France Recruiting
Hopital Pitie-Salpetriere Paris France Recruiting
Tenon Hospital Paris France Recruiting
Nouvel Hopital Civil Strasbourg France Not Yet Recruiting

+ 30 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05947955 on ClinicalTrials.gov ↗ ← All trials in the UK