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 B: Participants will be randomized to receive either a placebo or paridiprubart.
This record describes the default procedures and analyses for Cohort B. 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.
Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80
Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater
PPD Development, LP
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
InflaRx GmbH
Collaborator
Edesa Biotech Inc.
Collaborator
Genentech, Inc.
Collaborator