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.
None
ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.
PPD Development, LP
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
InflaRx GmbH
Collaborator
Edesa Biotech Inc.
Collaborator
Genentech, Inc.
Collaborator