CTRI/2020/05/025216已完成不适用
Evaluation of Cardiac Safety of Hydroxychloroquin for pre COVID 19 Exposure Prophylaxis : Smart Remote Continuous Ambulatory Electrocardiographic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Rohit Walia
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- No of patients with QT prolongation by 25 percentage of baseline
研究概览
简要总结
Normal people taking hydroxchloroquin for COVID 19 pre exposure prophylaxis will be monitored through contnous ambulatory telemetry device for any QT prolongation and arrhythmias for continuous seven days from start of medicine to generate cardiac safety data.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •people taking pre exposure COVID 19 hydroxychloroquin prophylaxis Written informed consent.
排除标准
- •Corrected QT greater than 480 ms Known congenital Long QT Co moralities and contraindications to hydroxychloroquin Retinopathy Known hypersensitivity to chloroquine Cardiomyopathy, prolonged QTc, cardiac arrhythmias • History of psoriasis, porphyria cutanea tarda Epilepsy Myasthenia gravis, myopathy of any cause Serious hepatic or renal disease Known glucose-6-phosphate dehydrogenase deficiency Current use of medication with known serious hepatotoxic effects or known interaction with chloroquine Severe depression Electrolyte imbalance Anti arrhythmic drugs Cardiac devices like pacemaker , defibrillators.
结局指标
主要结局
No of patients with QT prolongation by 25 percentage of baseline
时间窗: 7 days
No of patients with QT prolongation greater than 500 ms
时间窗: 7 days
No of patients with ventricular arrhythmias
时间窗: 7 days
Syncope
时间窗: 7 days
Sudden cardiac Death
时间窗: 7 days
次要结局
- Any drug related adverse events(Any Syncope , all cause mortality)
研究者
研究点 (1)
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