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RecruitingNCT05947955Updated Oct 20, 2026

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

A Phase 2 interventional study of Rhu-pGSN and normal saline in Acute Respiratory Distress Syndrome and Infections, sponsored by BioAegis Therapeutics Inc.. Recruiting at 65 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by BioAegis Therapeutics Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Updated Oct 20, 20265 sites removedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

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:

  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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
  • Infections

Keywords

  • moderate to severe ARDS
  • respiratory failure
  • rhu-pGSN
03

In context

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

This study's planned enrollment of 600 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

BioAegis Therapeutics Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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 must agree to use 2 medically accepted and approved 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

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 clinical trial (e.g., device, drug, or biologic) in the previous 30 days
  8. Known allergy to study drug or
  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, , 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 \<6 months unrelated to acute infection in the opinion of the Investigator.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugRhu-pGSN

    Intravenous administration based on actual body weight

    Also known as: recombinant human gelsolin

  • Drugnormal saline

    intravenous administration in the same volume as the active therapy

    Also known as: 0.9% sterile saline

06

What researchers measure

Primary outcomes

  1. All-cause mortality at day 28

    Death for any reason through Day 28 between treatment groups

    Time frame: 28 days

Secondary outcomes

  1. Ventilator-free days

    Ventilator-free days through Day 28 between treatment groups

    Time frame: 28 days

  2. All-cause mortality at day 60

    Death for any reason through Day 60 between treatment groups

    Time frame: 60 days

  3. Proportion of surviving subjects without respiratory support

    Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups

    Time frame: 28 days

  4. 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

    Time frame: 28 days

  5. 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

    Time frame: 28 days

  6. Frequency of intubation

    For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups

    Time frame: 28 days

  7. Days in the ICU and in the hospital

    Days in the ICU and in the hospital through Day 28 between treatment groups

    Time frame: 28 days

  8. Frequency of RRT

    Frequency of renal replacement therapy (RRT) through Day 28 between treatment groups

    Time frame: 28 days

  9. 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

    Time frame: 28 days

07

Study locations

63 of 65 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Oct 2027, 35 months after the start.

Of 59 phase 2 interventional studies under Respiratory Distress Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2023
First posted
Jul 17, 2023
StartActual
Oct 3, 2024
Primary completionEst.
Oct 1, 2027
CompletionEst.
Mar 1, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
5 sites removed
Show 5 removed
  • Bryan Medical Center · Lincoln, United States
  • Penn State Health - Milton S. Hershey Medical Center · Hershey, United States
  • Baylor Scott & White Health · Temple, United States
  • Spital Universitar de Urgenta ELIAS (University Emergency Hospital Elias) · Bucharest, Romania
  • Hospital Universitari de Tarragona Joan XXIII · Tarragona, Spain
Oct 20, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Penn State Health - Milton S. Hershey Medical Center · Hershey, United StatesContact person changed (no phone or email listed)Contact none listed→•••7508
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    5 sites removed
    Show 5 removed
    • Bryan Medical Center · Lincoln, United States
    • Penn State Health - Milton S. Hershey Medical Center · Hershey, United States
    • Baylor Scott & White Health · Temple, United States
    • Spital Universitar de Urgenta ELIAS (University Emergency Hospital Elias) · Bucharest, Romania
    • Hospital Universitari de Tarragona Joan XXIII · Tarragona, Spain
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Penn State Health - Milton S. Hershey Medical Center · Hershey, United StatesContact person changed (no phone or email listed)Contact none listed→•••7508
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05947955
Lead sponsor
BioAegis Therapeutics Inc.
Collaborators
Biomedical Advanced Research and Development Authority
Responsible party
Sponsor
First posted
Jul 17, 2023
Start date
Oct 3, 2024
Primary completion
Oct 1, 2027 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Howard Levy, MD PhD
Contact
hlevy@hlevyconsulting.com
848-992-5888
Dmytro Pomishchyk
Contact
dmytro.pomishchyk@ergomedgroup.com
502-648-2138

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Gelsolin

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