A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure
Start Date
5/26/2026
Completion Date
8/1/2027
Summary
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).
Detailed Description
This trial will be conducted in 2 parts (Run-in Phase; Phase 2). The Run-in Phase is designed to characterize the baseline population of the site, where participants will receive open-label agenT-797 plus SOC. After completion of the Run-in Phase, participants will be enrolled and randomized to receive either agenT-797 plus SOC or placebo plus SOC during the double-blinded Phase 2.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
agenT-797
Placebo
Standard of Care (SOC)
Conditions
Locations
UCSF Medical Center at Parnassus Heights
San Francisco, California 94143
United States
Children's Memorial Hermann Hospital
Houston, Texas 77030
United States
University Hospital
San Antonio, Texas 78229
United States
First Lviv Territorial Medical Union
Lviv, 79059
Ukraine