About this trial
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
Qualifiers
None
Disqualifiers
ARDS Severity of mild, moderate or severe, based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization.
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+
Trial design
Treatments tested in this trial
- Cohort C: bevacizumab
- Cohort C: placebo
Treatment groups
Sponsors and collaborators
PPD Development, LP
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
InflaRx GmbH
Collaborator
Edesa Biotech Inc.
Collaborator
Genentech, Inc.
Collaborator