Evaluating Bevacizumab for Acute Respiratory Distress Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 multicenter, randomized, double-blinded, placebo-controlled trial aims to assess the safety and efficacy of bevacizumab, a host-directed therapeutic, in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS). Participants will be randomly assigned to receive either bevacizumab or a placebo while continuing standard ARDS treatments. The study will monitor various outcomes, including ventilatory status, oxygenation, and survival, over a period of approximately 90 days. Data will be collected through physical exams, laboratory assessments, and questionnaires to evaluate the treatment's impact.

Why it matters

Who can join: the full rules

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:

  1. 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.
  2. 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.
  3. 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.
  4. Participant with a history of hypertensive crisis or hypertensive encephalopathy.
  5. Participant with a history of Grade ≥ 4 venous thromboembolisms.
  6. Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.
  7. Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.
  8. Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.
  9. Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).
  10. 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.
  11. Participant with a platelet count of \<75×109/L.
  12. Participant with current or recent (\<10 days prior to initiation of study treatment) use of aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day).
  13. Participant is receiving a direct anticoagulant (DOAC) such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) without the availability of a reversal agent at the site.
  14. Participant is receiving a DOAC such as betrixaban (Bevyxxa®) and edoxaban (Lixiana®) for which there is no approved reversal agent.
  15. Participant has urine dipstick for proteinuria ≥ 2+

Where it's running

• Community Regional Medical Center
  Fresno, California, United States Recruiting
• Long Beach Memorial Medical Center
  Long Beach, California, United States Recruiting
• University of California Irvine Medical Center
  Orange, California, United States Recruiting
• University of California Davis Medical Center - Pulmonary Medicine
  Sacramento, California, United States Recruiting
• Stanford Medical Center
  Stanford, California, United States Recruiting
• Denver Health Hospital and Authority
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Just Breathe Trial Team
• Email: crgjustbreathealerts.sm@thermofisher.com
• Phone: Please email

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Innovative therapies for Acute Respiratory Distress Syndrome

  This study is testing new treatments for adults in the hospital with Acute Respiratory Distress Syndrome to see if they can improve breathing and overall recovery compared to a placebo.

  Recruiting at 27 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06703073

• Evaluating vilobelimab for treating Acute Respiratory Distress Syndrome

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  Recruiting at 28 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06701682

• Evaluating a new treatment for Acute Respiratory Distress Syndrome

  This study is testing a new treatment called paridiprubart to see if it can help hospitalized adults with Acute Respiratory Distress Syndrome breathe better and improve their chances of recovery.

  Recruiting at 28 sites Phase 2 PPD Development, LP · Birmingham, Alabama and 40 other locations · NCT06701669

• Treatment for Acute Respiratory Distress Syndrome using Extracellular Vesicles

  This study is testing a new treatment called ExoFlo to see if it can help hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome breathe better and improve their overall health.

  Recruiting at 31 sites Phase 3 Direct Biologics, LLC · Phoenix, Arizona and 31 other locations · NCT05354141

• Pulse Wave vs Saline Bolus EIT to measure lung perfusion in ARDS

  This study tests whether pulse wave EIT or saline bolus EIT can best show lung blood flow in ARDS patients on mechanical ventilation.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07908368

• Multicenter group study of sepsis and ARDS in China

  This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.

  Recruiting at 24 sites Shanghai Zhongshan Hospital · Xiamen, Fujian and 23 other locations · NCT07863908

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.