Phase 2 Trial of Recombinant Human Plasma Gelsolin with Standard Care for Moderate-to-Severe ARDS from Pneumonia or Infection

What this Trial Is About

Researchers are evaluating recombinant human plasma gelsolin rhu-pGSN combined with standard care for adults with moderate-to-severe Acute Respiratory Distress Syndrome ARDS caused by pneumonia or other infections. This Phase 2 study aims to assess the safety and effectiveness of rhu-pGSN in patients who develop acute hypoxemic respiratory failure within seven days of infection and require mechanical or noninvasive ventilation or high-flow oxygen support. Potential participants are screened within 24 hours of ARDS diagnosis to confirm eligibility based on oxygenation levels and infection status. Participants are randomly assigned to receive either rhu-pGSN or a saline placebo alongside standard care. Treatment consists of a single loading dose of 24 mgkg rhu-pGSN followed by five daily doses of 12 mgkg, delivered intravenously through a filter. The study drug or placebo is administered within 48 hours of moderate-to-severe ARDS diagnosis. The study includes detailed assessments such as medical history, imaging, blood tests, cultures, and pregnancy tests when applicable. Safety is monitored by an independent board with periodic reviews. During the study, participants undergo regular evaluations including blood sampling for immune response and biomarker analysis, imaging tests, and cultures as needed. The primary outcome is all-cause mortality at 28 days, with additional assessments of survival, ventilator use, ICU and hospital stay lengths, and adverse events up to 60 days. Follow-up visits occur at 14 and 28 days after discharge, including telephone checks at 60 days. The total participation duration varies depending on individual progress and clinical status.

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)