JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPPD Development, LP

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

200 Participants
are divided into 2 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