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New treatment option for Acute Respiratory Distress Syndrome
Official title Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
ClinicalTrials.gov ID: NCT05947955
What this study is testing
What is Rhu-pGSN?
Rhu-pGSN is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute respiratory distress syndrome.
Also referred to as recombinant human gelsolin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency...
- 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...
You likely can't join if
- Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac...
- 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
See the full eligibility 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...
- 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...
- Age ≥18 years
- 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 people of childbearing potential must agree to use 2 medically accepted and approved birth control methods
- Male people 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 people must agree not to donate sperm or eggs
- 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Rochester, Minnesota, United States
- Hannibal, Missouri, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Hershey, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Temple, Texas, United States
- Brussels, Belgium
- Charleroi, Belgium
- Liège, Belgium
- Ottignies, Belgium
- Sofia, Bulgaria
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- North Vancouver, British Columbia, Canada
+ 36 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Augusta, Georgia, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States; Rochester, Minnesota, United States; Hannibal, Missouri, United States and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.