Testing Rhu-pGSN against a placebo for acute respiratory distress syndrome
Official title: Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
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
- Phase 2
- 2 groups
- Sites in Calgary, Edmonton and 3 more cities
- Recruiting
Interventions
- Medication
Rhu-pGSN
Intravenous administration based on actual body weight
- Medication
normal saline
intravenous administration in the same volume as the active therapy
Canadian Sites (10)
10 of 10 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
- Recruiting
Grey Nuns Hospital
Edmonton, Alberta
- Recruiting
Lions Gate Hospital
North Vancouver, British Columbia
- Recruiting
Peter Lougheed Centre
Calgary
- Recruiting
Rocky View General Hospital
Calgary
- Recruiting
South Health Campus
Calgary
- 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
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years
- +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
- +InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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.
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or primary care team
- +During the course of the study starting at screening and for at least 3 months after their final study treatment:
- +All subjects must agree not to donate sperm or eggs
- +Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth controlControl groupThe group a new treatment is measured against.Read more → 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
Exclusion
- −Known allergy to study drug or excipients
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →; 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)
- −Previous splenectomy
- −Any vaccination in the previous 30 days
- −Participation in an investigational clinical trialInterventional studyA study where participants are given something to see what happens.Read more → (e.g., device, drug, or biologic) in the previous 30 days
- −Weight \>125 kg
- −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.
- −Pregnant or lactating women
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Rhu-pGSN.
Registry label: A: Rhu-pGSN Treatment
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives normal saline.
Registry label: B: Normal Saline Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 600 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: 28 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
All-cause mortality at day 28 — measured over 28 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05947955 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Rhu-pGSNDrug
Intravenous administration based on actual body weight
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About normal salineDrug
intravenous administration in the same volume as the active therapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 28 days.
The study as a whole is currently expected to finish around 2027-03-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Calgary, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; North Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (2)
Mayo Clinic
Rochester, Minnesota, United States
New York University Grossman School of Medicine
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.