NCT06701682 JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
| NCT ID | NCT06701682 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | PPD Development, LP |
| Condition | Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-21 |
| Primary Completion | 2028-07 |
Trial Parameters
Eligibility Fast-Check
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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 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: * No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.