Phase 2 Study Testing New Treatments for Adults Hospitalized with Acute Respiratory Distress Syndrome ARDS

What this Trial Is About

Researchers are conducting a Phase 2 multicenter, randomized, double-blinded, placebo-controlled platform trial to evaluate host-directed therapeutic candidates for hospitalized adults diagnosed with Acute Respiratory Distress Syndrome ARDS. The study aims to assess the safety and efficacy of multiple investigational treatments compared to placebo, while all participants continue receiving standard ARDS care as determined by their doctors. Each treatment is studied in its own cohort within the overall platform design. Participants will be randomized to receive one of several treatments or placebo. Cohort A receives vilobelimab, administered as up to six intravenous doses on specified days if still hospitalized and appropriate. Cohort B receives a single intravenous dose of paridiprubart on Day 1, and Cohort C receives a single intravenous dose of bevacizumab on Day 1. Matching placebos are given accordingly. Treatment starts after screening, which must occur within 24 hours of consent, and continues through hospital discharge. Participants will be followed for about 90 days total, including a screening period, in-hospital treatment, and post-discharge follow-up extending two weeks after Day 90. They will undergo physical exams, laboratory tests, biomarker collections, ECGs, chest imaging, and questionnaires throughout the study. Researchers will measure outcomes such as mortality at Day 28 and later, oxygenation improvements, ventilator use, functional status, hospital resource use, and adverse events to evaluate treatment effects and safety.

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)