JPRN-jRCTs051200060已完成1 期
Evaluation of safety and efficacy of post exposure prophylaxis with hydroxychloroquine aiming at prevention of COVID-19 for medical care workers
Kakeya Hiroshi0 个研究点目标入组 0 人开始时间: 2020年9月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
Since all the papers reported so far on the preventive effe ct of hydroxychloroquine on COVID-19 are negative, and s ince the WHO has announced that it does not recommend the use of hydroxychloroquine as a prophylactic agent for covid-19, we concluded to cancel the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Male or female with age 18 or greater at the time of consent
- •(2) Is able to administrate the drug orally
- •(3) Is able to follow the schedule for medical exam defined in the research protocol
- •(4) Has provided written consent for participation
- •*The participants from age 18 to 20 have to provide written consents from both the subject and a legal guardian
- •*The participants are not limited to the workers who involve in infection control zone
排除标准
- •(1) History of COVID-19
- •(2) History of allergy for hydroxychroloquine
- •(3) weight less than 31kg
- •(4) Under medication with the drugs which are listed as contraindications for coadministration with HCQ
- •(5) History of retinopathy or macular degeneration
- •(6) Pregnant or planning pregnancy
- •(7) Breastfeeding
- •(8) Performance status of 2 or greater
- •(9) Advanced liver function abnormalities classified as grade C by the Child-Pugh criteria
- •(10) Renal disease classified CKD stage more than 4
- •(11) Allergy for quinine
- •(12) G-6-PD dificiency
- •(13) Porphyria
- •(14) scabies
- •(15) Under medication with gastrointestinal/neural/hematologic disorders
- •(16) Risk for ophthalmopathy
- •(17) Ventricular arrhythmia
- •(18) History of long QTc
- •(19) Deemed ineligible as determined by the principal investigator or a co-investigator
研究者
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