EUCTR2020-001224-33-DE进行中(未招募)1 期
Randomized controlled trial of hydroxychloroquine versus placebo for the treatment of adult patients with acute coronavirus disease 2019 – COVID-19
niversitätsklinikum Tübingen0 个研究点目标入组 220 人开始时间: 2020年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 220
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
- •Written informed consent
- •Age above 18 years
- •Women of childbearing age only: Must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year)
- •Disease severe enough to require hospitalisation
- •QTc interval lower than 450 msec
- •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 195
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Respiratory rate >24/min
- •Pregnancy or lactation
- •Weight <50 kg
- •Hemodynamic/rhythm instability
- •Acute myocardial infarction Type 1
- •Use of concomitant medications that prolong the QT/QTc interval.
- •Any regular concomitant medication which is contraindicated in the use together with HCQ
- •Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines
- •Pre-existing retinopathy or maculopathy
- •Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)
- •Haematopoietic systems diseases
- •Myasthenia gravis
- •Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
研究者
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