BridgeMD
New treatment option for Acute Respiratory Distress Syndrome (ARDS)
Official title JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab
ClinicalTrials.gov ID: NCT06701656
What this study is testing
What is Cohort C: bevacizumab?
Cohort C: bevacizumab 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. Cohort C: Participants will be randomized to receive either a placebo or bevacizumab.
- 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
- The following are in addition to the
You likely can't join if
- specified in the Master Protocol NCT06703073.
- ARDS Severity of mild, moderate or severe, based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization. Exclusion Criteria: The following...
- Participant has a known allergy or hypersensitivity to the active substance/excipients, or Chinese Hamster Ovary cell products or other recombinant...
- Participant with established cirrhosis and Child-Pugh Score of 7 or greater
- Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \< 2+
- The hospitalized participant has a history or currently experiencing the following:
See the full eligibility criteria
- The following are in addition to the
- specified in the Master Protocol NCT06703073.
- ARDS Severity of mild, moderate or severe, based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization. Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria...
- Participant has a known allergy or hypersensitivity to the active substance/excipients, or Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies
- Participant with established cirrhosis and Child-Pugh Score of 7 or greater
- Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \< 2+
- The hospitalized participant has a history or currently experiencing the following:
- Participant must not have an international normalized ratio (INR) \>1.5 and/or aPTT \>1.5 × upper limit of normal (ULN) within 7 days prior to initiation of study treatment for participants not receiving...
- Participant with recent serious hemorrhage or history of recent hemoptysis \> 2 episodes (defined as ≥2.5 mL of bright red blood per episode) within 1 month of screening.
- Participant with inadequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg). Antihypertensive therapy is permitted to achieve these parameters.
- Participant with a history of hypertensive crisis or hypertensive encephalopathy.
- Participant with a history of Grade ≥ 4 venous thromboembolisms.
- Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.
- Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.
- Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.
- Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).
- Participant with clinically significant cardiovascular disease including cerebrovascular accident or myocardial infarction within previous 6 months, unstable angina, congestive heart failure, or serious cardiac...
- Participant with a platelet count of \<75×109/L.
- Participant with current or recent (\ 325 mg/day) or clopidogrel (\>75 mg/day).
- Participant is receiving a direct anticoagulant (DOAC) such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) without the availability of a reversal agent at the site.
- Participant is receiving a DOAC such as betrixaban (Bevyxxa®) and edoxaban (Lixiana®) for which there is no approved reversal agent.
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.