Phase 2 Study of IC14 Monoclonal Antibody Treatment for Adults Hospitalized with Acute Respiratory Distress Syndrome ARDS

What this Trial Is About

Researchers are studying hospitalized adults with Acute Respiratory Distress Syndrome ARDS to evaluate the safety and effectiveness of IC14, a monoclonal antibody targeting the CD14 protein involved in inflammation and infection response. This phase 2, randomized, double-blind, placebo-controlled trial aims to reduce lung injury severity measured by the oxygenation index on day 4. Additional goals include assessing the impact on inflammation, oxygen levels, illness severity, mechanical ventilation duration, and mortality. Participants are randomly assigned to receive either IC14 or a placebo sterile saline. The study treatment is given intravenously while patients are hospitalized. Researchers will monitor IC14 levels in lung fluid and blood and measure a specific blood biomarker related to the CD14 pathway. The treatment period covers at least the first 4 days, with follow-up lasting 28 days. During the study, participants will be closely observed with various assessments including lung function tests, blood and lung fluid sampling for inflammation markers, oxygenation measurements, and organ failure scores. Safety will be monitored by tracking adverse events and serious complications throughout the 28-day follow-up. The main outcome is the oxygenation index at day 4, which reflects lung function and respiratory support needs.

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients