JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

Conditions: Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE2

Enrollment: 200

Sponsor: PPD Development, LP

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 A: Participants will be randomized to receive either a placebo or vilobelimab. This record describes the default procedures and analyses for Cohort A. 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 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 with established cirrhosis and a modified Child-Pugh Score of 12 or greater

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06701682). StuddyBuddy aggregates publicly available trial information.