Actively Recruiting
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Led by BioAegis Therapeutics Inc. · Updated on 2026-01-14
600
Participants Needed
76
Research Sites
125 weeks
Total Duration
On this page
Sponsors
B
BioAegis Therapeutics Inc.
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infection within 7 days before documented bilateral lung infiltrates or opacities consistent with ARDS
- Moderate-to-severe ARDS for 48 hours with a P/F ratio of 150 or less
- Receiving mechanical ventilation, noninvasive ventilation, or high-flow nasal oxygen of at least 30 L/min and 50% oxygen or more
- Age 18 years or older
- Informed consent obtained from the participant or their legal representative
- Clear evidence of infection causing ARDS within the past 7 days
- Female participants of childbearing potential must use two approved birth control methods during the study and for 3 months after
- Male participants with partners who may become pregnant must use reliable contraception, or partners must use acceptable birth control
- Participants must agree not to donate sperm or eggs during the study and for at least 3 months after
You will not qualify if you...
- Heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis contributing to symptoms
- Systemic fungal, yeast, parasitic, or mycobacterial infections
- Current or planned extracorporeal membrane oxygenation (ECMO) treatment
- Pregnant or breastfeeding women
- Previous removal of the spleen (splenectomy)
- Vaccination within the past 30 days
- Participation in another investigational clinical trial within the past 30 days
- Known allergy to the study drug or its components
- Body weight greater than 125 kg
- Active cancer or recent cancer treatment within the last 60 days or expected treatment in the next 6 months
- Organ or hematopoietic transplantation or related diseases
- Chronic mechanical ventilation or dialysis
- Severe, life-limiting diseases unrelated to infection that affect study participation or life expectancy less than 6 months not related to the current infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 76 locations
1
University of California Irvine Medical Center
Irvine, California, United States, 92868
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Wellstar MCG Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
4
Northwestern University - Pulmonary and Critical Care Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
5
University of Louisville Hospital - Jewish Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
University of Louisville-Jewish Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Hannibal Regional Hospital
Hannibal, Missouri, United States, 63401
Actively Recruiting
9
Bryan Medical Center
Lincoln, Nebraska, United States, 68506
Actively Recruiting
10
New York University Grossman School of Medicine
New York, New York, United States, 10016
Not Yet Recruiting
11
Penn State Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
12
Penn State Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
13
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Actively Recruiting
14
McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Baylor Scott & White Health
Temple, Texas, United States, 76508
Actively Recruiting
16
HUB - Hôpital Erasme
Brussels, Belgium, 1070
Actively Recruiting
17
CHU Charleroi Marie Curie Hospital
Charleroi, Belgium, 6042
Actively Recruiting
18
Centre Hospitalier Regional de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
19
Clinique Saint-Pierre Ottignies
Ottignies, Belgium, 1340
Actively Recruiting
20
Acibadem City Clinic UMHAT Tokuda - Sofia
Sofia, Bulgaria, 1407
Actively Recruiting
21
Military Medical Academy
Sofia, Bulgaria, 1606
Actively Recruiting
22
UMHAT "Alexandrovska" EAD
Sofia, Bulgaria
Actively Recruiting
23
Foothills Medical Centre
Calgary, Alberta, Canada, AB T2N 5A1
Actively Recruiting
24
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9
Actively Recruiting
25
Grey Nuns Hospital
Edmonton, Alberta, Canada, T6L 5X8
Actively Recruiting
26
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Actively Recruiting
27
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
28
University Health Network (UHN)-Toronto General Hospital (TGH)
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
29
McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
30
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, H4J1C5
Actively Recruiting
31
Peter Lougheed Centre
Calgary, Canada, T1Y 6J4
Actively Recruiting
32
Rocky View General Hospital
Calgary, Canada, T2V 1P9
Actively Recruiting
33
South Health Campus
Calgary, Canada, T3M 1M4
Actively Recruiting
34
St. Anne's University Hospital
Brno, Czechia, 602 00
Actively Recruiting
35
University Hospital Královské Vinohrady
Prague, Czechia, 100 34 10
Actively Recruiting
36
General University Hospital
Prague, Czechia, 2, 12000
Actively Recruiting
37
Centre Hospitalier Departemental (CHD) Vendee
La Roche-sur-Yon, France
Actively Recruiting
38
Hôpital du Kremlin Bicêtre, APHP
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
39
Centre Hospitalier de Melun-Senart
Melun, France, 77000
Actively Recruiting
40
CHU Nantes
Nantes, France, 1
Actively Recruiting
41
Centre Hospitalier Lyon Sud
Oullins-Pierre-Bénite, France, 69495
Actively Recruiting
42
Hopital Pitie-Salpetriere
Paris, France, 75013
Actively Recruiting
43
Tenon Hospital
Paris, France, 75020
Actively Recruiting
44
Nouvel Hopital Civil
Strasbourg, France, 67091
Not Yet Recruiting
45
Saarland University Hospital
Homburg, Germany, 66421
Actively Recruiting
46
Jena University Hospital
Jena, Germany, 07747
Actively Recruiting
47
University Hospital LMU Munich
Munich, Germany, D-81377
Actively Recruiting
48
National Institute of Pulmonology
Budapest, Hungary, H-1121
Actively Recruiting
49
Petz Aladár University Teaching Hospital
Győr, Hungary, H-9023
Actively Recruiting
50
Szent Damján Greek Catholic Hospital
Kisvárda, Hungary, 4600
Actively Recruiting
51
Szabolcs-Szatmar-Bereg County Teaching Hospital, Andras Josa Hospital
Nyíregyháza, Hungary, H-4400
Actively Recruiting
52
Hospital of Siofok
Siófok, Hungary, 8600
Actively Recruiting
53
Teaching Hospital of Vas County
Szombathely, Hungary
Actively Recruiting
54
Ferenc Csolnoky Hospital of Veszprem County
Veszprém, Hungary, H-8200
Actively Recruiting
55
Asst-Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
56
Fondazione Policlinico A. Gemelli IRCCS
Rome, Italy, 00165
Actively Recruiting
57
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Actively Recruiting
58
Gelre Hospitals, Department of ICU
Apeldoorn, Netherlands
Actively Recruiting
59
Gelderse Vallei Hospital
Ede, Netherlands
Actively Recruiting
60
Medisch Spectrum Twente
Enschede, Netherlands, 7512 KZ
Actively Recruiting
61
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532 SZ
Actively Recruiting
62
University Hospital of Bucharest
Bucharest, Romania, 050098
Actively Recruiting
63
Spital Universitar de Urgenta ELIAS (University Emergency Hospital Elias)
Bucharest, Romania
Actively Recruiting
64
County Clinical Hospital Tirgu Mures
Târgu Mureş, Romania, 540103
Actively Recruiting
65
Clinical County Hospital Timisoara
Timișoara, Romania, 300723
Actively Recruiting
66
Hospital Clínic Barcelona
Barcelona, Spain, 08030
Actively Recruiting
67
University Hospital of Bucharest
Barcelona, Spain, 08208
Actively Recruiting
68
Bellvitge University Hospital
Barcelona, Spain, 08907
Actively Recruiting
69
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
70
Hospital Universitario de Getafe
Madrid, Spain, 28905
Actively Recruiting
71
Clínico San Carlos
Madrid, Spain
Actively Recruiting
72
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43005
Actively Recruiting
73
Hospital Universitari Sant Joan de Reus
Tarragona, Spain, 43204
Actively Recruiting
74
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
75
Derriford Hospital (University Hospitals Plymouth Hospital Trust)
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
76
Pinderfields Hospital (Mid Yorkshire Teaching NHS Trust)
Wakefield, United Kingdom, WF1 4DG
Actively Recruiting
Research Team
H
Howard Levy, MD PhD
CONTACT
D
Dmytro Pomishchyk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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