Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

January 13, 2026 updated by: BioAegis Therapeutics Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS. The Sponsor aims to identify as early as possible patients in the hospital who have developed acute hypoxemic respiratory failure within 7 days of the precipitating infection (often fever, rigors, chills, increased heart rate, increased respiratory rate, pain, cough, etc.) leading to ARDS resulting in mechanical or noninvasive ventilation or high-flow nasal oxygen (HFNO) supplementation with ≥50% O2 at a flow rate of ≥30 L/min. Patients who do not qualify for the study at the initial screening visit because of mild ARDS may subsequently progress to moderate-to-severe ARDS and should be reassessed at least daily for the 7 days following the precipitating infection.

Once informed consent is obtained, the following assessments/procedures will be performed:

  1. Confirm the potential participant has acute hypoxemic respiratory failure qualifying as moderate-to-severe ARDS for ≤48 hours following a suspected or confirmed infection within the preceding week. Moderate-to-severe ARDS is defined by the calculated or estimated ratio of arterial pressure of O2 to the fraction of inspired O2 [P/F ratio] ≤150. The P/F ratio will be computed from the most recent arterial blood gas obtained no more than 12 hours earlier than randomization. For potential subjects on high-flow nasal oxygen with ≥50% O2 at a flow rate of ≥30 L/min, the P/F ratio will be estimated assuming 50% delivered O2. If eligible and entered in the trial, the following steps should be taken.
  2. Record medical history, including concomitant medications and current clinical status. Specify the site and etiology (if known) of infection, indicating if the lung ("direct ARDS") or another organ ("indirect ARDS") is the primary site of infection.
  3. Perform pregnancy test (urine or blood) for women of childbearing potential if not already performed during the current hospitalization.
  4. Collect pretreatment blood samples for measurement of baseline pGSN and analysis of antibodies against pGSN.
  5. Perform physical examination and document results of the chest x-ray (CXR) and/or computed tomography (CT) scan, if CXR is inadequate if not already available as per SOC.
  6. Obtain blood and sputum cultures and electrocardiogram (EKG) per SOC (if not already performed). Document the site of infection by collecting specimens as indicated: sputum (bacterial, viral, and mycobacterial, as indicated) and blood cultures, sputum Gram-stains, antigen detection on respiratory and urine specimens, and syndromic nucleic acid amplification tests (NAATs) on respiratory specimens (including a viral and other respiratory pathogen polymerase chain reaction [PCR] panel), where possible. Other specimens from possible sites of infection (e.g., urine, intra-abdominal drainage, skin or soft-tissue abscesses) should be cultured when available.
  7. Measure routine lab tests at local (hospital) laboratory per local custom/SOC collect aliquots f- blood for subsequent biomarker assays (including, but not limited to C-reactive protein [CRP], procalcitonin, interleukin [IL]1β, IL6, IL10, and tumor necrosis factor [TNF]) for analysis at the central laboratory.
  8. If eligibility criteria are satisfied, the subject will be randomized 1:1 (rhu-pGSN:placebo) by site to a treatment group and treated within 12 hours of randomization and no later than 48 hours after the diagnosis of moderate-to-severe ARDS.

Randomized subjects will receive the assigned dose of rhu-pGSN or an equal volume of visibly indistinguishable sterile saline placebo as soon as possible but beginning no later than 48 hours after the diagnosis of moderate-to-severe ARDS. After reconstitution, rhu-pGSN is not to be kept at room temperature for >2 hours prior to beginning study drug administration.

A single loading dose of rhu-pGSN at 24 mg/kg followed by 5 daily doses of rhu-pGSN at 12 mg/kg of measured or estimated actual body weight starting 24 hours after the loading dose or an equal volume of indistinguishable saline placebo will be administered. A window of ±2 hours will be allowed around dosing times. Study drug is administered by an IV push through a 0.2 μm filter. The syringe, filter, and extension tubing for administration of study drug are to be connected as close to the subjects as possible.

The primary efficacy endpoint of all-cause mortality will be assessed at Day 28. All-cause mortality will also be assessed on Days 7 and 14. Discharged subjects will undergo follow-up evaluation on Days 14 and 28, preferably but not necessarily in person. Survival at Day 60 will be confirmed by telephonic contact or after 3 failed attempts, review of hospital and public records that document survival or death.

Screening laboratory and other tests may be used as baseline values and do not need to be repeated if performed within 24 hours prior to randomization unless otherwise dictated by SOC. However, the blood sample for analysis of pGSN levels is to be repeated if not collected within 15 minutes before initiating the first dose of study drug.

Repeat CXRs and/or CT scans and labs/cultures are to be obtained during the hospitalization if/when indicated by SOC. On Days 1 (predose) and 28, blood samples for analysis of antibodies against pGSN are to be collected, if possible. Repeat blood and other cultures should be obtained per SOC.

An independent Data and Safety Monitoring Board (DSMB) consisting of at least 2 physicians and 1 statistician with appropriate scientific and medical expertise will be formed, and its roles and responsibilities will be described in the DSMB charter. The DSMB will perform 5 periodic reviews of safety data emphasizing deaths and SAEs and will monitor stopping rules to pause enrollment. There will be no pause on enrollment during the planned unblinded periodic reviews. These reviews will be performed after the first 50, 100, 200, 300, and 400 subjects in the Safety Analysis Set have either completed 28 days of follow-up, have died, or have discontinued from the study prior to completing 28 days of follow-up. DSMB members will be provided with unblinded data. Based on the results of each of the planned periodic reviews, the study will be paused only if there is a relative increase of 25 percentage points in the incidence of death or SAEs in the rhu-pGSN treatment group compared to the placebo group. A futility analysis will be performed at the 300-subject review. The Sponsor will take appropriate action based on the recommendation of the DSMB.

The DSMB will also review expedited reports of any SAEs throughout the study and may request additional looks at safety data at their discretion. Enrollment will continue during all safety analyses unless otherwise recommended by the DSMB chair.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • HUB - Hôpital Erasme
        • Contact:
        • Principal Investigator:
          • Fabio Taccone, MD
      • Charleroi, Belgium, 6042
        • Recruiting
        • CHU Charleroi Marie Curie Hospital
        • Contact:
        • Principal Investigator:
          • Michael Piagnerelli, MD
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Regional de la Citadelle
        • Principal Investigator:
          • Vincent Fraipont, MD
        • Contact:
      • Ottignies, Belgium, 1340
        • Recruiting
        • Clinique Saint-Pierre Ottignies
        • Principal Investigator:
          • Nicolas De Schryver, MD
        • Contact:
  • Bulgaria
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Military Medical Academy
        • Contact:
        • Principal Investigator:
          • Nikolay Petrov, MD
      • Sofia, Bulgaria
        • Recruiting
        • UMHAT "Alexandrovska" EAD
        • Contact:
        • Principal Investigator:
          • Yordanka Yamakova, MD
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic UMHAT Tokuda - Sofia
        • Contact:
        • Principal Investigator:
          • Nikolay Mladenov, MD
  • Canada
      • Calgary, Canada, T1Y 6J4
        • Recruiting
        • Peter Lougheed Centre
        • Contact:
        • Principal Investigator:
          • Christopher Doig, MD
      • Calgary, Canada, T2V 1P9
        • Recruiting
        • Rocky View General Hospital
        • Contact:
        • Principal Investigator:
          • Christopher Doig, MD
      • Calgary, Canada, T3M 1M4
        • Recruiting
        • South Health Campus
        • Contact:
        • Principal Investigator:
          • Christopher Doig, MD
    • Alberta
      • Calgary, Alberta, Canada, AB T2N 5A1
        • Recruiting
        • Foothills Medical Centre
        • Contact:
        • Principal Investigator:
          • Christopher Doig, MD
      • Edmonton, Alberta, Canada, T6L 5X8
      • Edmonton, Alberta, Canada, T5H3V9
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Recruiting
        • Lions Gate Hospital
        • Contact:
        • Principal Investigator:
          • James Joshua Douglas, MD
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Principal Investigator:
          • Neill Adhikari, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G 2N2
        • Recruiting
        • University Health Network (UHN)-Toronto General Hospital (TGH)
        • Contact:
        • Principal Investigator:
          • Niall Ferguson, MD
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH)
        • Contact:
        • Principal Investigator:
          • Peter Goldberg, MD
      • Montreal, Quebec, Canada, H4J1C5
        • Recruiting
        • Centre intégré universitaire de santé et services sociaux du nord de l'île de Montréal-Hôpital du Sacré de Montréal (CIUSSS-NÎM-HSCM)
        • Contact:
        • Principal Investigator:
          • Martin Albert, MD
  • Czechia
      • Brno, Czechia, 602 00
        • Recruiting
        • St. Anne's University Hospital
        • Contact:
        • Principal Investigator:
          • Pavel Suk, MD
      • Prague, Czechia, 100 34 10
        • Recruiting
        • University Hospital Královské Vinohrady
        • Principal Investigator:
          • František Duška, MD
        • Contact:
      • Prague, Czechia, 2, 12000
        • Recruiting
        • General University Hospital
        • Contact:
        • Principal Investigator:
          • Michal Otáhal, MD
  • France
      • La Roche-sur-Yon, France
        • Recruiting
        • Centre Hospitalier Departemental (CHD) Vendee
        • Principal Investigator:
          • Jean-Claude Lacherade, MD
        • Contact:
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • Hôpital du Kremlin Bicêtre, APHP
        • Contact:
        • Principal Investigator:
          • Tai Pham, MD
      • Melun, France, 77000
        • Recruiting
        • Centre Hospitalier de Melun-Senart
        • Principal Investigator:
          • Mehran MONCHI, MD
        • Contact:
      • Nantes, France, 1
        • Recruiting
        • CHU Nantes
        • Principal Investigator:
          • Jean-Baptiste Lascarrou, MD
        • Contact:
      • Oullins-Pierre-Bénite, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
        • Principal Investigator:
          • Bernard Allaouchiche, MD
      • Paris, France, 75013
        • Recruiting
        • Hôpital Pitié-Salpêtrière
        • Contact:
        • Principal Investigator:
          • Alexandre Demoule, MD
      • Paris, France, 75020
        • Recruiting
        • Tenon Hospital
        • Principal Investigator:
          • Muriel Fartoukh, MD
        • Contact:
      • Strasbourg, France, 67091
        • Not yet recruiting
        • Nouvel Hôpital Civil
        • Contact:
        • Principal Investigator:
          • Julie Helms, MD
  • Germany
      • Homburg, Germany, 66421
        • Recruiting
        • Saarland University Hospital
        • Contact:
        • Principal Investigator:
          • Andreas Meiser, MD
      • Jena, Germany, 07747
        • Recruiting
        • Jena University Hospital
        • Contact:
        • Principal Investigator:
          • Johannes Ehler, MD
      • Munich, Germany, D-81377
        • Recruiting
        • University Hospital LMU Munich
        • Contact:
        • Principal Investigator:
          • Sandra Kristina Frank, MD
  • Hungary
      • Budapest, Hungary, H-1121
        • Recruiting
        • National Institute of Pulmonology
        • Contact:
        • Principal Investigator:
          • Szabolcs Szigeti, MD
      • Győr, Hungary, H-9023
        • Recruiting
        • Petz Aladár University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Csaba Hermann, MD
      • Kisvárda, Hungary, 4600
        • Recruiting
        • Szent Damján Greek Catholic Hospital
        • Principal Investigator:
          • Norbert Erdélyi, MD
        • Contact:
      • Nyíregyháza, Hungary, H-4400
        • Recruiting
        • Szabolcs-Szatmar-Bereg County Teaching Hospital, Andras Josa Hospital
        • Principal Investigator:
          • Attila Szucs, MD
        • Contact:
      • Siófok, Hungary, 8600
        • Recruiting
        • Hospital of Siofok
        • Principal Investigator:
          • Agnes Seer, MD
        • Contact:
      • Szombathely, Hungary
        • Recruiting
        • Teaching Hospital of Vas County
        • Contact:
        • Principal Investigator:
          • Peter Nemeth, MD
      • Veszprém, Hungary, H-8200
        • Recruiting
        • Ferenc Csolnoky Hospital of Veszprem County
        • Contact:
        • Principal Investigator:
          • Bela Gal, MD
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Asst-Spedali Civili di Brescia
        • Contact:
        • Principal Investigator:
          • Michele Bertoni, MD
      • Rome, Italy, 00165
        • Recruiting
        • Fondazione Policlinico A. Gemelli IRCCS
        • Principal Investigator:
          • Domenico Luca Grieco, MD
        • Contact:
  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Recruiting
        • Jeroen Bosch Ziekenhuis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koen Simons, MD
      • Apeldoorn, Netherlands
        • Recruiting
        • Gelre Hospitals, Department of ICU
        • Contact:
        • Principal Investigator:
          • Peter E Spronk, MD PhD
      • Ede, Netherlands
        • Recruiting
        • Gelderse Vallei Hospital
        • Contact:
          • Yvonne Swaen
          • Phone Number: +31(0)318434126
          • Email: SwaenY@zgv.nl
        • Contact:
        • Principal Investigator:
          • Arthur R.H. van Zanten, MD PhD
      • Enschede, Netherlands, 7512 KZ
        • Recruiting
        • Medisch Spectrum Twente
        • Contact:
        • Contact:
        • Principal Investigator:
          • Albertus Beishuizen, MD
      • Nijmegen, Netherlands, 6532 SZ
        • Recruiting
        • Canisius Wilhelmina Ziekenhuis
        • Principal Investigator:
          • Oscar Hoiting, MD
        • Contact:
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Spital Universitar de Urgenta ELIAS (University Emergency Hospital Elias)
        • Contact:
        • Principal Investigator:
          • Sylvius Negoita, MD
      • Bucharest, Romania, 050098
        • Recruiting
        • University Hospital of Bucharest
        • Contact:
        • Principal Investigator:
          • Andreea Monica Birjaru, MD
      • Timișoara, Romania, 300723
        • Recruiting
        • Clinical County Hospital Timisoara
        • Principal Investigator:
          • Ovidiu Bedreag, MD
        • Contact:
      • Târgu Mureş, Romania, 540103
        • Recruiting
        • County Clinical Hospital Tirgu Mures
        • Contact:
        • Principal Investigator:
          • Mircea Stoian, MD
  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Bellvitge University Hospital
        • Contact:
        • Principal Investigator:
          • Oriol Roca, MD
      • Barcelona, Spain, 08030
        • Recruiting
        • Hospital Clinic Barcelona
        • Principal Investigator:
          • Pedro Castro Rebollo, MD
        • Contact:
      • Barcelona, Spain, 08208
        • Recruiting
        • University Hospital of Bucharest
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilio Diaz Santos, MD
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Mario Chico-Fernández, MD
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Clinico San Carlos
        • Contact:
        • Principal Investigator:
          • Miguel Sanchez Garcia, MD
      • Madrid, Spain, 28905
        • Recruiting
        • Hospital Universitario de Getafe
        • Principal Investigator:
          • Jose Lorente, MD
        • Contact:
      • Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitari de Tarragona Joan XXIII
        • Contact:
        • Principal Investigator:
          • Alejandro Hugo Rodriguez Oviedo, MD
      • Tarragona, Spain, 43204
        • Recruiting
        • Hospital Universitari Sant Joan de Reus
        • Contact:
        • Principal Investigator:
          • Juan Antonio Brito Piris, MD
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
        • Contact:
        • Principal Investigator:
          • Matt P Wise, MD
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital (University Hospitals Plymouth Hospital Trust)
        • Contact:
        • Principal Investigator:
          • Nikitas Nikitas, MD
      • Wakefield, United Kingdom, WF1 4DG
        • Recruiting
        • Pinderfields Hospital (Mid Yorkshire Teaching NHS Trust)
        • Contact:
        • Principal Investigator:
          • Brendan Sloan, MD
  • United States
    • California
      • Irvine, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center
        • Principal Investigator:
          • Alpesh Amin, MD
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Yuri Matusov, MD
        • Contact:
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Wellstar MCG Augusta University
        • Contact:
        • Principal Investigator:
          • Shaheen Islam, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University - Pulmonary and Critical Care Medicine
        • Contact:
        • Principal Investigator:
          • Richard G Wunderink, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Hospital - Jewish Hospital
        • Principal Investigator:
          • Mohamed Saad, MD
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville-Jewish Hospital
        • Principal Investigator:
          • Mohamed Saad, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Yewande Odeyemi, M.B.B.S.
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Recruiting
        • Hannibal Regional Hospital
        • Principal Investigator:
          • Humam Farah, MD
        • Contact:
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Bryan Medical Center
        • Principal Investigator:
          • Radu Neamu, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Not yet recruiting
        • New York University Grossman School of Medicine
        • Contact:
        • Principal Investigator:
          • Sam Parnia, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health - Milton S. Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Lauren Van Scoy, MD
      • Pittsburgh, Pennsylvania, United States, 15261
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan McVerry, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center
        • Principal Investigator:
          • Bela Patel, MD
        • Contact:
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Health
        • Contact:
        • Principal Investigator:
          • Alfredo Vazquez Sandoval, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rhu-pGSN Treatment
Subjects will receive rhu-pGSN 24 mg/kg once, followed by 5 daily doses of 12 mg/kg based on actual body weight in addition to standard care .
Drug: Rhu-pGSN
Intravenous administration based on actual body weight
Other Names:
  • recombinant human gelsolin
Placebo Comparator: Normal Saline Placebo
Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care.
Drug: normal saline
intravenous administration in the same volume as the active therapy
Other Names:
  • 0.9% sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality at day 28
Time Frame: 28 days
Death for any reason through Day 28 between treatment groups
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free days
Time Frame: 28 days
Ventilator-free days through Day 28 between treatment groups
28 days
All-cause mortality at day 60
Time Frame: 60 days
Death for any reason through Day 60 between treatment groups
60 days
Proportion of surviving subjects without respiratory support
Time Frame: 28 days
Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups
28 days
Time to death and proportions of subjects dying over time
Time Frame: 28 days
Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups
28 days
Time to discontinuation of respiratory support and proportions without respiratory support
Time Frame: 28 days
Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups
28 days
Frequency of intubation
Time Frame: 28 days
For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups
28 days
Days in the ICU and in the hospital
Time Frame: 28 days
Days in the ICU and in the hospital through Day 28 between treatment groups
28 days
Frequency of RRT
Time Frame: 28 days
Frequency of renal replacement therapy (RRT) through Day 28 between treatment groups
28 days
SAEs and AEs
Time Frame: 28 days
Incidence, causality, and severity of SAEs and AEs (graded according to the NCI CTCAE version 5.0 [or higher]) between treatment groups
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAegis Therapeutics Inc.

Collaborators

Biomedical Advanced Research and Development Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 9, 2023

First Submitted That Met QC Criteria

July 9, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTI-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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