A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Safety
研究概览
简要总结
Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.
详细描述
Up to 160 patients with ARDS will be randomized to receive either IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 or placebo for 4 days beginning within 48 hours of meeting inclusion criteria. Study participation will be for 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU admission
- •Age 18-70 years
- •Presence of a known ARDS clinical risk within 7 days of onset:
- •Pancreatitis
- •Presence of ARDS (per Berlin criteria) defined as follows:
- •Acute onset (<48 hours)
- •PaO2/FiO2<300 on PEEP≥5
- •Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules.
- •Requirement for positive pressure ventilation via endotracheal tube
- •Anticipated duration of mechanical ventilation >48 hrs
排除标准
- •Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
- •Intubation for cardiopulmonary arrest
- •Do-not-attempt resuscitation (DNAR) status
- •Intubation for status asthmaticus, pulmonary embolus, myocardial infarction
- •Anticipated survival <48 hours from intubation
- •Anticipated survival <28 days due to pre-existing medical condition
- •Significant pre-existing organ dysfunction
- •Lung: Currently receiving home oxygen therapy as documented in medical record
- •Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record
- •Renal: Chronic renal failure requiring renal replacement therapy
- •Liver: Severe chronic liver disease defined as Child-Pugh Class C
- •Pre-existing, ongoing immunosuppression
- •Solid organ transplant recipient
- •Chronic high-dose corticosteroids (equivalent to >20 mg/prednisone/day for >14 days in the last 30 days)
- •Oncolytic drug therapy within the past 14 days
- •Known HIV positive with CD4 count <200 cells/mm3
- •Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept)
- •History of hypersensitivity or idiosyncratic reaction to IC14
- •Deprivation of freedom by administrative or court order
研究组 & 干预措施
IC14
IC14 4 mg/kg IV on Study Day 1, then IC14 2 mg/kg IV once daily on Study Days 2-4.
干预措施: IC14 (Drug)
Placebo
Placebo IV once daily on Study Day 1-4
干预措施: Placebo (Other)
结局指标
主要结局
Safety
时间窗: 28 days
Treatment-emergent adverse events
Ventilator-free days
时间窗: 28 days
The number of days alive and free of mechanical ventilation through Day 28.
Safety
时间窗: 28 days
Treatment-emergent adverse events
Ventilator-free days
时间窗: 28 days
The number of days alive and free of mechanical ventilation through Day 28.
次要结局
- Change in ARDS biologic markers.(28 days)