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
More than two vasopressors to maintain a mean arterial pressure ≥65 millimeters of mercury at the time of informed consent
Pregnancy or breastfeeding
History of cytokine release syndrome, as documented in the medical record or reported by the participant, legally authorized representative, or close relative
Current participation in another interventional clinical trial, or receipt of an investigational medicinal product within 30 days prior to screening, unless reviewed and approved in writing by the medical monitor
Sequential
agenT-797
DrugIntravenous infusion
Placebo
DrugIntravenous infusion
Standard of Care (SOC)
DrugAntimicrobial therapy and corticosteroids per applicable guidelines.
Number of Deaths (All-cause Mortality)
Number of Oxygenation Support-free Days
Time to Resolution of Hypoxemia
Number of Ventilator-free Days
Number of Intensive Care Unit-free Days
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