Health Trials

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 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

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cohort A: vilobelimab
  • Cohort A: placebo

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

40
Alabama
University of Alabama Hospital35233-1932, Birmingham United States
California
Community Regional Medical Center93721-1324, Fresno United States
Long Beach Memorial Medical Center90806-1701, Long Beach United States
University of California Irvine Medical Center92868-3201, Orange United States

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

Source ClinicalTrials.gov