Phase 2 Adaptive Randomized, Placebo -Controlled Trial of agenT-797 + Standard of Care Vs. Placebo + Standard of Care in Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure (AHRF) By Global ARDS Criteria
This clinical trial will evaluate the efficacy and safety of a single intravenous dose of agenT-797 administered in addition to standard of care (SOC), compared with placebo plus SOC, in reducing short-term mortality in adult participants with severe pneumonia and moderate to severe AHRF. All participants will receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS).
• Admission to an intensive care unit (ICU) with severe pneumonia of any etiology (viral, bacterial, fungal, or mixed), with and without trauma based on clinical suspicion
• Acute hypoxemic respiratory failure (AHRF)
• Evidence of moderate to severe acute respiratory distress syndrome (ARDS) based on Global ARDS criteria
• Onset of severe pneumonia with AHRF ≤7 days prior to informed consent