Phase 2 Adaptive Randomized, Placebo-Controlled Trial of agenT-797 plus Standard of Care versus Placebo plus Standard of Care in Severe Pneumonia with Moderate to Severe Acute Hypoxemic Respiratory Failure by Global ARDS Criteria

What this Trial Is About

Researchers are evaluating the safety and effectiveness 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). The study aims to reduce short-term mortality in this patient group and is conducted in two parts: an initial Run-in Phase and a Phase 2 randomized, double-blinded phase. All participants receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS). In the Run-in Phase, participants receive open-label agenT-797 plus SOC to help characterize the baseline population. After this phase, participants are randomized to one of two groups in Phase 2: agenT-797 plus SOC or placebo plus SOC. Both treatments are given as intravenous infusions, and SOC includes antimicrobial therapy and corticosteroids following guidelines. Participants will be monitored from Day 1 through Day 28 for outcomes such as mortality, days without oxygen support or ventilator use, time to resolution of hypoxemia, ICU-free days, infections, antibiotic-free days, and time to hospital discharge. Additional measurements include mortality at Day 90 and changes in cytokine profiles at baseline and on Days 3, 7, and 14. The study includes safety monitoring and assessments throughout the trial period, which is expected to end in August 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