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