Acute Respiratory Distress SyndromePhase 2NCT05947955
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study testing Rhu-pGSN and normal saline in people with Acute Respiratory Distress Syndrome and Infections, run by BioAegis Therapeutics Inc. at 65 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Infections
- What is being tested?
- Rhu-pGSN and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 65 sitesin 13 countries
- Study dates
- 3 Oct 2024to 1 Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
- Age ≥18 years
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- Informed consent obtained from subject/next of kin/legal proxy
- 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
- During the course of the study starting at screening and for at least 3 months after their final study treatment:
- Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods
- 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
- All subjects must agree not to donate sperm or eggs
Who cannot join
- 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.
- Presence of systemic fungal, yeast, parasitic, or mycobacterial infection
- Current or planned receipt of extracorporeal membrane oxygenation (ECMO)
- Pregnant or lactating women
- Previous splenectomy
- Any vaccination in the previous 30 days
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- Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days
- Known allergy to study drug or excipients
- Weight >125 kg
- 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
- Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease
- Chronic mechanical ventilation or dialysis
- 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.
Trial locations and contacts
65 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
65 sites in 13 countries
United States11 sites, 11 recruiting
- Recruiting
Wellstar MCG Augusta University
Augusta, Georgia, 30912
Marti Farrough, RN, 706-723-0106, mfarrough@augusta.edu
Shaheen Islam, MD
- Recruiting
Northwestern University - Pulmonary and Critical Care Medicine
Chicago, Illinois, 60611
Helen K Donnelly, MS, BSN, RN, CCRC, 312-503-1097, Helen K Donnelly <h-donnelly@northwestern.edu>
Richard G Wunderink, MD
- Recruiting
Hannibal Regional Hospital
Hannibal, Missouri, 63401
Lindsey Gander, RN CRC, 573-629-3926, Lindsey.Gander@hannibalregional.org
Humam Farah, MD
- Recruiting
Penn State Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Kylee Kimbel, (717) 802-7508, kkimbel@pennstatehealth.psu.edu
Lauren Van Scoy, MD
- Recruiting
McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center
Houston, Texas, 77030
Elizabeth Vidales, 713-486-6154, Elizabeth.Vidales@uth.tmc.edu
Bela Patel, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vivian Hwe, 424-314-0585, Vivian.Hwe@cshs.org
Yuri Matusov, MD
- Recruiting
University of Louisville Hospital - Jewish Hospital
Louisville, Kentucky, 40202
Julie Burmester, 502-852-2601, julie.burmester@louisville.edu
Mohamed Saad, MD
- Recruiting
University of Louisville-Jewish Hospital
Louisville, Kentucky, 40202
Julie Burmester, 502-852-2601, Julie.burmester@louisville.edu
Mohamed Saad, MD
- Not yet recruiting
New York University Grossman School of Medicine
New York, New York, 10016
Natalia Leontovich, 917-227-0932, Natalia.Leontovich@nyulangone.org
Sam Parnia, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Chelsea Peet, michelessic2@upmc.edu
Bryan McVerry, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Amy Schuchard, 507-293-7023, schuchard.amy@mayo.edu
Yewande Odeyemi, M.B.B.S.
Canada10 sites, 10 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, AB T2N 5A1
Maha Khaleel, 403-944-0740 /403-944-4334, maha.khaleel@albertahealthservices.ca
Christopher Doig, MD
- Recruiting
Peter Lougheed Centre
Calgary, T1Y 6J4
Maha Khaleel, 403-944-0740 /403-944-4334, maha.khaleel@albertahealthservices.ca
Christopher Doig, MD
- Recruiting
Rocky View General Hospital
Calgary, T2V 1P9
Maha Khaleel, 403-944-0740 /403-944-4334, maha.khaleel@albertahealthservices.ca
Christopher Doig, MD
- Recruiting
South Health Campus
Calgary, T3M 1M4
Maha Khaleel, 403-944-0740 /403-944-4334, maha.khaleel@albertahealthservices.ca
Christopher Doig, MD
- Recruiting
Grey Nuns Hospital
Edmonton, Alberta, T6L 5X8
Anushka Jayasekara, 780-735-7068, Anushka.Jayasekara@covenanthealth.ca
Janek Senaratne, MD
- Recruiting
McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH)
Montreal, Quebec, H4A 3J1
Rayhaneh Rahgoshai, (514) 934-1934 ext. ext. 65542, rayhaneh.rahgoshai@muhc.mcgill.ca
Peter Goldberg, MD
- 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, H4J1C5
Virginie Williams, 514 338 2222 ext. 5833272, virginie.williams.cnmtl@ssss.gouv.qc.ca
Martin Albert, MD
- Recruiting
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7
Valla Sahraei, 604 988 3131 ext. 4934, Valla.Sahraei@vch.ca
James Joshua Douglas, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Nicole Marinoff, 416-480-6100 ext. ext. 83734, nicole.marinoff@sunnybrook.ca
Neill Adhikari, MD
- Recruiting
University Health Network (UHN)-Toronto General Hospital (TGH)
Toronto, Ontario, M5G 2N2
Clarissa Chau, 416-340-4800 ext. 6056, Clarissa.Chau2@uhn.ca
Niall Ferguson, MD
France8 sites, 8 recruiting
- Recruiting
Centre Hospitalier Departemental (CHD) Vendee
La Roche-sur-Yon
Natacha Maquigneau, 02 51 44 60 26, natacha.maquigneau@ght85.fr
Jean-Claude Lacherade, MD
- Recruiting
Hôpital du Kremlin Bicêtre, APHP
Le Kremlin-Bicêtre, 94275
Alain FOURREAU, 01 45 21 70 68, alain.fourreau@aphp.fr
Tai Pham, MD
- Recruiting
Centre Hospitalier de Melun-Senart
Melun, 77000
Abdelkader ROUAB, 0181742801, abdelkader.rouab@ghsif.fr
Mehran MONCHI, MD
- Recruiting
CHU Nantes
Nantes, 1
Camille JUHEL, 276643944, camille.juhel@chu-nantes.fr
Jean-Baptiste Lascarrou, MD
- Recruiting
Centre Hospitalier Lyon Sud
Oullins-Pierre-Bénite, 69495
Bernard Allaouchiche, MD, +33 478 861 918, bernard.allaouchiche@gmail.com
Bernard Allaouchiche, MD
- Recruiting
Hopital Pitie-Salpetriere
Paris, 75013
Nabila Fares, 33142167813, nabila.fares@aphp.fr
Alexandre Demoule, MD
- Recruiting
Tenon Hospital
Paris, 75020
Muriel Fartoukh, MD, 01 56 01 65 72, muriel.fartoukh@aphp.fr
Muriel Fartoukh, MD
- Not yet recruiting
Nouvel Hopital Civil
Strasbourg, 67091
Allam Hayat, +33 369 55 04 86, hayat.allam@chru-strasbourg.fr
Julie Helms, MD
Spain7 sites, 7 recruiting
- Recruiting
Hospital Clínic Barcelona
Barcelona, 08030
Montserrat Solá, +34 932 275 708, MSOLA@recerca.clinic.cat
Pedro Castro Rebollo, MD
- Recruiting
University Hospital of Bucharest
Barcelona, 08208
Emilio Diaz Santos, MD, +34 937233923, ediazsan@tauli.cat
Gemma Goma, 937231010 ext 81109, ggoma@tauli.cat
- Recruiting
Bellvitge University Hospital
Barcelona, 08907
Diana Kaptoul, +34 93.260.75.00 ext. ext: 8147, dkaptoul@idibell.cat
Oriol Roca, MD
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Adrián Marcos, +34 644 85 70 72, adrian_m16@hotmail.com
Mario Chico-Fernández, MD
- Recruiting
Hospital Universitario de Getafe
Madrid, 28905
Alejandro Selas, +34 648 649 364, alejandro.selas@salud.madrid.org
Jose Lorente, MD
- Recruiting
Clínico San Carlos
Madrid
Belén de la Hera, +34 913 30 30 00 ext. 484242, belenhhernanz@gmail.com
Miguel Sanchez Garcia, MD
- Recruiting
Hospital Universitari Sant Joan de Reus
Tarragona, 43204
Juan Antonio Brito Piris Piris, MD, +34 636519135, britopiris@gmail.com
Juan Antonio Brito Piris, MD
Hungary5 sites, 5 recruiting
- Recruiting
National Institute of Pulmonology
Budapest, H-1121
Szabolcs Szigeti, MD, 36303987917, szigeti.szabolcs@koranyi.hu
Szabolcs Szigeti, MD
- Recruiting
Szent Damján Greek Catholic Hospital
Kisvárda, 4600
Norbert Erdélyi, MD, 36703277123, erdelyi.norbert@kisvardakorhaz.hu
Norbert Erdélyi, MD
- Recruiting
Szabolcs-Szatmar-Bereg County Teaching Hospital, Andras Josa Hospital
Nyíregyháza, H-4400
Attila Szucs, MD, 36203609577, dr.szucs.attila@szszbmk.hu
Attila Szucs, MD
- Recruiting
Hospital of Siofok
Siófok, 8600
Agnes Seer, MD, 36209305293, seeragnes@gmail.com
Agnes Seer, MD
- Recruiting
Ferenc Csolnoky Hospital of Veszprem County
Veszprém, H-8200
Bela Gal, MD, 36301600308, gal.bela@vmkorhaz.hu
Bela Gal, MD
Netherlands5 sites, 5 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Angela Bouman, +31(0)735532857, An.bouman@jbz.nl
Tamara van Zuylen, +31(0)735532857, t.v.zuylen@jbz.nl
- Recruiting
Gelre Hospitals, Department of ICU
Apeldoorn
Peter E Spronk, MD PhD, +31(0) 55 5818451, p.spronk@gelre.nl
Peter E Spronk, MD PhD
- Recruiting
Gelderse Vallei Hospital
Ede
Yvonne Swaen, +31(0)318434126, SwaenY@zgv.nl
Mireille Salakory, +31(0)318436317, SalakoryM@zgv.nl
- Recruiting
Medisch Spectrum Twente
Enschede, 7512 KZ
Martin Rinket, +31(0)650883300, m.rinket@mst.nl
Tim Krol, +31(0)652733962, t.krol@mst.nl
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ
Mirjam Evers, +31 (0)24 365 7915, researchic@cwz.nl
Oscar Hoiting, MD
Belgium4 sites, 4 recruiting
- Recruiting
HUB - Hôpital Erasme
Brussels, 1070
Durand Dominique, 0032 (0)2555 44 54, Dominique.durand@hubruxelles.be
Fabio Taccone, MD
- Recruiting
CHU Charleroi Marie Curie Hospital
Charleroi, 6042
Michaël Piagnerelli, 0032 (0)71922125, Michael.piagnerelli@humani.be
Michael Piagnerelli, MD
- Recruiting
Centre Hospitalier Regional de la Citadelle
Liège, 4000
Sophie Jacquet, 0032 (0)4 321 85 01, sophie.jacquet@citadelle.be
Vincent Fraipont, MD
- Recruiting
Clinique Saint-Pierre Ottignies
Ottignies, 1340
Nicolas De Schryver, MD, 0032 (0)10 43 77 34, nicolas.deschryver@cspo.be
Nicolas De Schryver, MD
Czechia3 sites, 3 recruiting
- Recruiting
St. Anne's University Hospital
Brno, 602 00
Pavel Suk, MD, +420 605 436 695, pavel.suk@fnusa.cz
Pavel Suk, MD
- Recruiting
University Hospital Královské Vinohrady
Prague, 100 34 10
Marie Chaloupecká, +420 267 162 461, studijnisestry@gmail.com
František Duška, MD
- Recruiting
General University Hospital
Prague, 2, 12000
Michal Otáhal, MD, +420 724 120 970, michal.otahal@vfn.cz
Michal Otáhal, MD
Germany3 sites, 3 recruiting
- Recruiting
Saarland University Hospital
Homburg, 66421
Kathrin Meiers, +49 (0)6841-16 30080, kathrin.meiers@uks.eu
Andreas Meiser, MD
- Recruiting
Jena University Hospital
Jena, 07747
Petra Bloos, +49 (0) 3641 9 32 33 90, Petra.Bloos@med.uni-jena.de
Johannes Ehler, MD
- Recruiting
University Hospital LMU Munich
Munich, D-81377
Janine Coppa, +49 152 54889271, Janine.Coppa@med.uni-muenchen.de
Sandra Kristina Frank, MD
Romania3 sites, 3 recruiting
- Recruiting
University Hospital of Bucharest
Bucharest, 050098
Andreea Monica Birjaru, MD, 40721537566, andreea.birjaru@gmail.com
Andreea Monica Birjaru, MD
- Recruiting
County Clinical Hospital Tirgu Mures
Târgu Mureş, 540103
Mircea Stoian, MD, +40 745200362, mircea.stoian@umfst.ro
Mircea Stoian, MD
- Recruiting
Clinical County Hospital Timisoara
Timișoara, 300723
Ovidiu Bedreag, MD, +40722371641, ovidiu.bedreag@yahoo.com
Ovidiu Bedreag, MD
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
Helen Hill, +44 (0) 29 2184 3608 ext. 7440, helen.hill@wales.nhs.uk
Matt P Wise, MD
- Recruiting
Derriford Hospital (University Hospitals Plymouth Hospital Trust)
Plymouth, PL6 8DH
Liana Stapleton, 07902034859, liana.stapleton@nhs.net
Nikitas Nikitas, MD
- Recruiting
Pinderfields Hospital (Mid Yorkshire Teaching NHS Trust)
Wakefield, WF1 4DG
Abigail Crew, 01924 544156 ext. x54156, abigail.crew@nhs.net
Brendan Sloan, MD
Italy2 sites, 2 recruiting
- Recruiting
Asst-Spedali Civili di Brescia
Brescia, 25123
Michele Bertoni, MD, 0039 3388558175, michele.bertoni@unibs.it
Michele Bertoni, MD
- Recruiting
Fondazione Policlinico A. Gemelli IRCCS
Rome, 00165
Domenico Luca Grieco, 0039 3397681623, dlgrieco@outlook.it
Domenico Luca Grieco, MD
Bulgaria1 site, 1 recruiting
- Recruiting
UMHAT "Alexandrovska" EAD
Sofia
Monika Spirova, 359882067375, monika.spirova@clineca.net
Yordanka Yamakova, MD
About this study
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
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.
Read the 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:
- 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.
- 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.
- Perform pregnancy test (urine or blood) for women of childbearing potential if not already performed during the current hospitalization.
- Collect pretreatment blood samples for measurement of baseline pGSN and analysis of antibodies against pGSN.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Acute Respiratory Distress Syndrome, Infections
- Being tested
- Rhu-pGSN, normal saline
- Keywords
- moderate to severe ARDS, respiratory failure, rhu-pGSN
- Medical subject headings
- Respiratory Distress Syndrome, Infections, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhu-pGSNDrug
Also called recombinant human gelsolin
Intravenous administration based on actual body weight
normal salineDrug
Also called 0.9% sterile saline
intravenous administration in the same volume as the active therapy
| Study group | Role | What they receive |
|---|---|---|
| Rhu-pGSN Treatment | Experimental | 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 . Receives: Drug: Rhu-pGSN |
| Normal Saline Placebo | Placebo comparator | Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at day 28
Death for any reason through Day 28 between treatment groups
Measured: 28 days
Secondary outcomes (9)
Ventilator-free days
Ventilator-free days through Day 28 between treatment groups
Measured: 28 days
All-cause mortality at day 60
Death for any reason through Day 60 between treatment groups
Measured: 60 days
Proportion of surviving subjects without respiratory support
Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups
Measured: 28 days
Time to death and proportions of subjects dying over time
Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups
Measured: 28 days
Time to discontinuation of respiratory support and proportions without respiratory support
Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups
Measured: 28 days
Frequency of intubation
For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups
Measured: 28 days
Days in the ICU and in the hospital
Days in the ICU and in the hospital through Day 28 between treatment groups
Measured: 28 days
Frequency of RRT
Frequency of renal replacement therapy (RRT) through Day 28 between treatment groups
Measured: 28 days
SAEs and AEs
Incidence, causality, and severity of SAEs and AEs (graded according to the NCI CTCAE version 5.0 [or higher]) between treatment groups
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start3 Oct 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to rhu-pGSN or saline placebo arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAegis Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947955
- Sponsor's protocol ID
- BTI-203
- Other IDs
- 75A50123C00067
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes