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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Run-in Phase is open label and non-randomized, Phase 2 is double blind and randomized.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo plus SOC
Participants will receive placebo and SOC.
干预措施: Placebo (Drug)
Placebo plus SOC
Participants will receive placebo and SOC.
干预措施: Standard of Care (SOC) (Drug)
agenT-797 plus SOC
Participants will receive agenT-797 and SOC.
干预措施: Standard of Care (SOC) (Drug)
agenT-797 plus SOC
Participants will receive agenT-797 and SOC.
干预措施: agenT-797 (Drug)