NCT04854837已完成不适用
Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Adverse event frequency
研究概览
简要总结
The FDA approved the antiviral drug remdesivir for use in adults for the treatment of COVID-19 requiring hospitalization.
There are only limited data about the safety of the drug in hemodialysed patents. Chronic kidney disease is a risk factor in COVID-19 for developing severe disease.
The aim of our investigation is to observe the safety of remdesivir among hemodialysed patients requiring hospitalization for COVID-19.
We are going to compare two group's data:
- Hemodialysed COVID-19 patients requiring hospitalization because of pneumonia and need of oxygen supplementation, and admitted after 12/Apr/2021 - these patients received remdesivir.
- Hemodialysed COVID-19 patients requiring hospitalization because of pneumonia and need of oxygen supplementation, and admitted before 12/Apr/2021 - these patients did not receive remdesivir.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adult patients at least 18 ys. of age
- •Ability to understand and sign informed consent form
- •End stage kidney disease of any cause, requiring hemodialysis
- •COVID-19 disease (with at least one positive SARS-CoV-2 RT-PCR or COVID-19 antigene quick test)
- •Radiologic evidence for pneumonia
- •Need for oxygen supplemental oxygen
排除标准
- •Hemodynamically unstable patients (systolic blood pressure <90Hgmm; heart rate>120/min)
- •Significant liver enzyme elevation at screening (ASAT or ALAT >2.5×ULN)
- •QTc > 470 msec at baseline ECG (Bazett formule)
- •Need for mechanical ventilation or intensive care unit admission
- •Limited life expectancy (<3 months)
研究组 & 干预措施
Hemodialysed patients received remdesivir
Remdesivir: day-1: 200 mg intravenously; day 2-5: 100 mg intravenously
干预措施: Remdesivir (Drug)
结局指标
主要结局
Adverse event frequency
时间窗: 14 days after completion of treatment
Number of adverse events occuring through the observational period
次要结局
- Significant ALAT elevation(continuously, 14 days after completion of treatment)
- Significant ASAT elevation(continuously, 14 days after completion of treatment)
- Significant ALP elevation(continuously, 14 days after completion of treatment)
- Significant seBi elevation(continuously, 14 days after completion of treatment)
- Frequency of suspected drug-induced injury(continuously, 14 days after completion of treatment)
- QTc prolongation(continuously, 14 days after completion of treatment)
- Arrhythmia occurence(continuously, 14 days after completion of treatment)
研究者
Istvan Takacs
Head of department
Semmelweis University
研究点 (1)
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