A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure

Official title

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

Overview

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.

Interventions

• Drug agenT-797
  Intravenous infusion
• Drug Placebo
  Intravenous infusion
• Drug Standard of Care (SOC)
  Antimicrobial therapy and corticosteroids per applicable guidelines.

Primary outcome measures

• Number of Deaths (All-cause Mortality) [Time frame: Day 1 through Day 28]

Secondary outcome measures (9)

• 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 [Time frame: Baseline, Day 3, Day 7, Day 14]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• UCSF Medical Center at Parnassus Heights — San Francisco
• Children's Memorial Hermann Hospital — Houston
• University Hospital — San Antonio

Ukraine · 1 center

• First Lviv Territorial Medical Union — Lviv

Identifiers

NCT: NCT07615010 · C-1300-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗