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

Launched by PPD DEVELOPMENT, LP · Nov 20, 2024

Keywords

ClinConnect Summary

The JUST BREATHE trial is studying a treatment called bevacizumab for adults who are hospitalized with Acute Respiratory Distress Syndrome (ARDS), a serious condition that affects breathing. This trial is in its second phase and aims to find out if this treatment is safe and effective compared to a placebo, which is a substance with no active medication. Participants will be randomly assigned to receive either the treatment or the placebo, and the study is currently recruiting individuals aged 65 and older who have mild to severe ARDS.

To be eligible for the trial, participants should not have certain medical conditions, such as serious heart problems, significant bleeding disorders, or allergies to specific medications. During the study, participants will receive close monitoring to ensure their safety and to evaluate how well the treatment works. This trial is important because it could lead to new therapies for ARDS, which can significantly impact patients' lives.

Gender

ALL

Eligibility criteria

• 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 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.