EUCTR2020-001453-49-ES进行中（未招募）1 期
Expanded Access Treatment Protocol: Remdesivir (RDV;GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection- COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,191
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this
- •1) Willing and able to provide written informed consent, or with a legal representative who can
- •provide informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as
- •deemed necessary by the investigator (participants = 18 years of age)
- •2) Age = 18 years
- •3) Hospitalized with confirmed SARS-CoV2 by PCR or known contact of confirmed case with
- •syndrome consistent with COVID-19 with PCR pending
- •4) Requiring invasive mechanical ventilation (e.g., via endotracheal intubation or tracheostomy)
- •5) Adequate renal function with estimated glomerular filtration rate = 30 ml/min by local
- •laboratory measure
- •6) ALT = 5 x upper limit of normal (ULN) by local laboratory measure
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1) Evidence of multiorgan failure
- •2) Pressor requirement to maintain blood pressure
- •3) Renal failure (eGRF < 30 mL/min or dialysis or continuous Veno-Venous Hemofiltration
- •4) Pregnancy
研究者
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