A Randomized, Double-blind, Dose-ranging, Placebo Controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19 (INTEGRIS-ARDS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0
研究概览
简要总结
Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
详细描述
Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to placebo (3:1 ratio).
- In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD
- In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809 or placebo QD
- In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809 or placebo QD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of ARDS (Berlin Criteria)
- •Hospitalized with at least severe COVID-19 (FDA 2020)
- •Receiving support for acute lung injury/respiratory distress via supplemental oxygen
- •Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine aminotransferase (ALT) concentration ≤ 150 U/L
- •Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis
排除标准
- •Greater than 72 hours since time of onset of ARDS.
- •Greater than 7 days since start of mechanical ventilation.
- •Currently receiving or anticipated to receive extracorporeal life support (ECLS), extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation
- •Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6 mL/kg of predicted body weight and prone positioning) and fluid management protocol (Fluids and Catheters Treatment Trial [FACTT] Conservative or Lite) per local institutional standards (HFOV).
研究组 & 干预措施
PLN-74809 Dose Level 2
Dose Level 2 of PLN-74809
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level1
Dose Level 1 of PLN-74809
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level1
Dose Level 1 of PLN-74809
干预措施: Placebo (Drug)
PLN-74809 Dose Level 2
Dose Level 2 of PLN-74809
干预措施: Placebo (Drug)
PLN74809 Dose Level 3
Dose Level 3 of PLN-74809
干预措施: PLN-74809 (Drug)
PLN74809 Dose Level 3
Dose Level 3 of PLN-74809
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0
时间窗: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.
次要结局
未报告次要终点