Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death
研究概览
简要总结
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients.
Many raised concerns regarding the potential cardiac toxicity of this association.
The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure.
The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin.
排除标准
- •cardiac conduction disorders
- •continuous anti-arrhythmic therapy
- •heart failure
- •chronic renal failure
结局指标
主要结局
occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death
时间窗: 30 days after admission in ICU
次要结局
- assessment of QTc interval prolongation during the treatment period compared to baseline ECG(daily)