BridgeMD
New treatment option for Acute Respiratory Distress Syndrome (ARDS)
Official title JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
ClinicalTrials.gov ID: NCT06703073
What this study is testing
What is Cohort A: vilobelimab?
Cohort A: vilobelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute respiratory distress syndrome (ards).
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
- This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.
- 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
- Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements
- Participant is at least 18 years of age or older at the time of consent.
- Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS. Note that participants on noninvasive ventilation may be...
- Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal...
- Participant agrees to not participate in another investigational treatment study while participating in this study (i.e., through Day 90).
You likely can't join if
- Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.
- Participant with pulmonary edema due to cardiogenic pulmonary edema/fluid overload or hypoxemia primarily attributable atelectasis, in the absence of...
- Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such...
- Participant is known to be pregnant, nursing, or with a positive (urine and/or serum test) pregnancy test.
- Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.
- Participant is not expected to survive for 72 hours.
See the full eligibility criteria
- Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements
- Participant is at least 18 years of age or older at the time of consent.
- Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS. Note that participants on noninvasive ventilation may be screened.
- Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional...
- Participant agrees to not participate in another investigational treatment study while participating in this study (i.e., through Day 90).
- Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.
- Participant with pulmonary edema due to cardiogenic pulmonary edema/fluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.
- Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to...
- Participant is known to be pregnant, nursing, or with a positive (urine and/or serum test) pregnancy test.
- Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.
- Participant is not expected to survive for 72 hours.
- Participant has been on invasive mechanical ventilation or ECMO for more than 48 hours for ARDS at the time of consent.
- Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation
- Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for...
- Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.
- Participant has NY Heart Association Class IV congestive heart failure.
- Participant has a known allergy to any study medication or any of its excipients.
- Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication. NOTE: Patients on chronic low dose immunosuppressive therapy may be enrolled...
- Participant is undergoing active cancer systemic chemotherapy.
- Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.
- Participant with concurrent infections or history of the following:
- Known active tuberculosis,
- Known active Hepatitis B, or
- HIV and a CD4 count less than 50 or a detectable viral load of \>200 copies/mL HIV RNA.
- Participant received treatment with any other investigational drugs within 30 days prior to consent.
- Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of...
- Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. Participant may have additional cohort-specific requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fresno, California, United States
- Long Beach, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Bradenton, Florida, United States
- Gainesville, Florida, United States
- Sarasota, Florida, United States
- Boise, Idaho, United States
- Evanston, Illinois, United States
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Reno, Nevada, United States
- New Brunswick, New Jersey, United States
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Birmingham, Alabama, United States; Fresno, California, United States; Long Beach, California, United States; Orange, California, United States; Sacramento, California, United States; Denver, Colorado, United States and 30 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.