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

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+