Investigation of IRAK4 Inhibition to Mitigate the Impact of COVID-19 in Severe SARS-CoV-2 (I-RAMIC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- All-cause mortality at Day 29
研究概览
简要总结
The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19.
详细描述
Proposed is a randomized, double-blind, placebo-controlled, parallel group Phase 2 study of the efficacy and safety of PF-06650833, an investigational drug, in hospitalized adult male and female patients with SARS-CoV-2-induced ARDS who need mechanical ventilation.
The primary objective of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19, evidence of increased inflammation, and ARDS requiring mechanical ventilation or extracorporeal membrane oxygenation at time of admission.
The secondary objectives of this study are to evaluate:
- Proportion of patients alive, extubated, and receiving no more that low flow oxygen supplementation by nasal cannula or face mask (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 2-point improvement in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale (1 = non hospitalized, no limitations on activity, and 8 = death) at Days 29 and 61
- Proportion of patients alive, extubated, and receiving any level oxygen supplementation, including non-invasive positive pressure ventilation or high flow oxygen device (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 1-point improvement in the NIAID ordinal scale (1 = non hospitalized, no limitations on activity, and 8 = death) at Days 29 and 61
- Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity (Days 8, 15, 22, 29, and 61). The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows:
- Not hospitalized, no limitations on activities;
- Not hospitalized, limitation on activities and/or requiring home oxygen*
- Hospitalized, not requiring supplemental oxygen* - no longer requires ongoing medical care
- Hospitalized, not requiring supplemental oxygen* - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, requiring supplemental oxygen*;
- Hospitalized, on non-invasive ventilation (NIV)** or high flow oxygen device;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PF-06650833 + Standard of Care
Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric [NG] tube, orogastric [OG] tube, or equivalent) if unable to take tablets by mouth (PO). All dosing of PF-06650833 will be in addition to current hospital SOC therapy.
干预措施: PF-06650833 (Drug)
Placebo + Standard of Care
Matching placebo tablets will be administered.
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause mortality at Day 29
时间窗: Up to 29 days
All-cause mortality at Day 29 (end of planned treatment period).
次要结局
- Disease Severity (8 point scale)(29 days)
- Mortality(61 days)
- P/F ratio(Up to 29 days)
- Change of the SOFA score.(Up to 29 days)
- Duration (days) of mechanical ventilation(Up to 29 days)
- Ventilator free days.(Up to 29 days)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 29 days)
研究者
Hyung Chun
Associate Professor
Yale University