NCT06701656 · PPD Development, LP
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab
What this study is about
This is a Phase 2 conducted at multiple hospitals, randomly assigned, double-blinded, compared against an inactive treatment study that will evaluate the safety and effectiveness of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.
View original scientific description
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. This record describes the default procedures and analyses for Cohort C.
Interventions
DRUG
Cohort C: bevacizumab
Administered as a single IV dose of 500 mg on Day 1
DRUG
Cohort C: placebo
Administered as a single IV dose of placebo on Day 1
Primary outcome measures
All-cause mortality (ACM) rate at Day 28
Time frame: Day 28
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The following inclusion criteria are in addition to the
Exclusion criteria
- 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 specified in the Master Protocol NCT06703073.
- 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 a modified 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 anticoagulation. For participants on full dose oral or parenteral anticoagulants for therapeutic purposes the INR and/or activated partial thromboplastin time (aPTT) must be within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment.
- 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 arrhythmia uncontrolled by medication.
- Participant with a platelet count of \<75×109/L.
- Participant with current or recent (\<10 days prior to initiation of study treatment) use of aspirin (\>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.
- Participant has urine dipstick for proteinuria ≥ 2+
Where
- Birmingham, Alabama
- Fresno, California
- Long Beach, California
- Orange, California
- Sacramento, California
- Stanford, California
- Denver, Colorado
- Washington D.C., District of Columbia
- Bradenton, Florida
- Gainesville, Florida
- Sarasota, Florida
- Boise, Idaho
And 25 more locations — see the full list below.
Collaborators
Biomedical Advanced Research and Development Authority, InflaRx GmbH, Edesa Biotech Inc., Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2026 · Source of record for eligibility and locations