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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Intravenous infusion
Intravenous infusion
Antimicrobial therapy and corticosteroids per applicable guidelines.
UCSF Medical Center at Parnassus Heights
San Francisco, California, United States
NOT_YET_RECRUITINGChildren's Memorial Hermann Hospital
Houston, Texas, United States
NOT_YET_RECRUITINGUniversity Hospital
San Antonio, Texas, United States
NOT_YET_RECRUITINGFirst Lviv Territorial Medical Union
Lviv, Ukraine
RECRUITINGNumber of Deaths (All-cause Mortality)
Time frame: Day 1 through Day 28
Number of Oxygenation Support-free Days
Time frame: Day 1 through Day 28
Time to Resolution of Hypoxemia
Time frame: Day 1 through Day 28
Number of Ventilator-free Days
Time frame: Day 1 through Day 28
Number of Intensive Care Unit-free Days
Time frame: Day 1 through Day 28
Number of Participants Experiencing New Secondary Bacterial, Antimicrobial-resistant, or Fungal Infections
Time frame: Day 1 through Day 28
Number of Antibiotic-free Days
Time frame: Day 1 through Day 28
Time to Hospital Discharge
Time frame: Day 1 through Day 28
Number of Deaths (All-cause Mortality)
Time frame: Day 1 through Day 90
Change From Baseline in Cytokine Profiles
Cytokine profiles analyzed may include interleukin-6, tumor necrosis factor-alpha, interleukin-1-beta, interleukin-1 receptor antagonist, soluble receptor for advanced glycation end product, angiopoietin-1 and -2, and tumor necrosis factor receptor 1.
Time frame: Baseline, Day 3, Day 7, Day 14
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