Phase 2 Study of Intravenous agenT-797 Plus Standard Care Compared to Placebo in Adults with Severe Pneumonia and Moderate to Severe Acute Hypoxemic Respiratory Failure

What this Trial Is About

Researchers are evaluating the efficacy and safety of a single intravenous dose of agenT-797 combined with standard of care SOC compared to placebo plus SOC in adults with severe pneumonia and moderate to severe acute hypoxemic respiratory failure AHRF. This trial includes a run-in phase and a double-blinded phase 2, designed to reduce short-term mortality and improve clinical outcomes in this serious condition. The trial consists of two parts an initial open-label Run-in Phase where participants receive agenT-797 plus SOC to characterize the baseline population, followed by a randomized, double-blinded Phase 2 where participants receive either agenT-797 plus SOC or placebo plus SOC. SOC includes antimicrobial therapy and corticosteroids based on applicable guidelines. Treatments are given as intravenous infusions. Participants will be monitored from Day 1 through Day 28 for outcomes such as mortality, oxygenation support-free days, ventilator-free days, ICU-free days, new infections, antibiotic-free days, and time to hospital discharge. Additional assessments include cytokine profile changes at baseline, Day 3, Day 7, and Day 14. The study continues monitoring mortality up to Day 90. Overall, participants undergo intensive evaluations, including safety and efficacy assessments, during the study period lasting until 2027.

A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure