NCT04470622终止2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Proportion of Subjects Alive and Discharged From the Hospital.
研究概览
简要总结
The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.
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
- •Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain reaction (PCR), antigen or immunoglobulin M (IgM) antibody test.
- •Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen saturation of <94% by pulse oximetry on room air or requiring supplemental oxygen.
- •Not anticipated to require mechanical ventilation within 48 hours.
排除标准
- •Is taking high-dose hydroxychloroquine or chloroquine.
- •Is taking pimozide or strong or moderate CYP3A4 inhibitors.
- •Is currently receiving treatment with products intended to modify immune response to COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed), chemotherapy or on hemodialysis or peritoneal dialysis.
- •Has known hypersensitivity to any components of aprepitant injectable emulsion.
- •Has evidence of ARDS.
- •Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask, noninvasive positive pressure ventilation, or ECMO.
- •Has multiple organ failure.
- •Has current confirmed Influenza A or B infection, or a a history of organ or hematologic transplant, HIV, or active hepatitis B or hepatitis C infection.
研究组 & 干预措施
Treatment Group 1
Experimental
Aprepitant injectable emulsion.
干预措施: Aprepitant injectable emulsion (Drug)
Treatment Group 2
Placebo Comparator
Saline placebo.
干预措施: Saline Placebo (Drug)
结局指标
主要结局
Proportion of Subjects Alive and Discharged From the Hospital.
时间窗: 14 Days.
ITT Population.
次要结局
- Incidence of Treatment-emergent Adverse Events.(Through Day 56)
- Time to Discharge From Hospital.(56 Days.)
- Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO).(56 Days.)
- Change From Baseline in Interleukin 6 (IL-6).(Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo)))
研究者
研究点 (3)
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