NCT06701656 JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab
| NCT ID | NCT06701656 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | PPD Development, LP |
| Condition | Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-10-28 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06701656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06701656 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06701656 currently recruiting?
Yes, NCT06701656 is actively recruiting participants. Contact the research team at crgjustbreathealerts.sm@thermofisher.com for enrollment information.
Where is the NCT06701656 trial being conducted?
This trial is being conducted at Birmingham, United States, Fresno, United States, Long Beach, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT06701656 clinical trial?
NCT06701656 is sponsored by PPD Development, LP. The trial plans to enroll 200 participants.