JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome

In brief

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. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

Key facts

Study ID: NCT06701656
Run by: PPD Development, LP
People needed: 200
Starts: 2025-10-28
Expected to finish: 2028-09-01
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Swedish Medical Center — Seattle, Washington, United States (enrolling)
Community Regional Medical Center — Fresno, California, United States (enrolling)
Long Beach Memorial Medical Center — Long Beach, California, United States (enrolling)
University of California Irvine Medical Center — Orange, California, United States (enrolling)
University of California Davis Medical Center - Pulmonary Medicine — Sacramento, California, United States (enrolling)
Stanford Medical Center — Stanford, California, United States (enrolling)
Denver Health Hospital and Authority — Denver, Colorado, United States (enrolling)
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
Nova Clinical Research — Bradenton, Florida, United States (enrolling)
North Florida / South Georgia Veterans Health System — Gainesville, Florida, United States (enrolling)
Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
St. Luke's Boise Medical Center — Boise, Idaho, United States (enrolling)
Henry Ford Health Hospital — Detroit, Michigan, United States (enrolling)
Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)
Montefiore Hospital - Moses Campus — The Bronx, New York, United States (enrolling)
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
Durham VA Medical Center — Durham, North Carolina, United States (enrolling)
Mercy Health - St. Vincent Medical Center — Toledo, Ohio, United States (enrolling)
The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
Oregon Health and Science University — Portland, Oregon, United States (enrolling)
Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (enrolling)
Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
Baylor All Saints Medical Center — Fort Worth, Texas, United States (enrolling)
Intermountain Medical Center — Murray, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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