Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
United States, Belgium, Bulgaria600 participantsStarted 2024-10-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
. Informed consent obtained from subject/next of kin/legal proxy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial testing rhu-pGSN for ARDS, what does that mean for how much we already know about whether it's safe and effective compared to treatments that are already approved?
2The trial's main goal is to measure all-cause mortality at 28 days — does that mean participants may be critically ill when they enroll, and how would that affect my ability to make decisions or give consent if my condition gets worse quickly?
3ARDS can progress very fast — how would I or my family actually get enrolled in a trial like this in time, and what does participation realistically look like day-to-day in an ICU setting?
4Would joining this trial mean I'd be giving up or delaying any standard-of-care treatments for ARDS, or would rhu-pGSN be used alongside them?
5Given that this trial also involves patients with infections, would my specific infection history or current infection status affect whether this might be worth discussing as an option for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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
. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days