EUCTR2020-001456-18-CZ进行中（未招募）1 期
Azithromycin added to Hydrochloroquine in Patients Admitted to Intensive Care due to Coronavirus Disease 2019 (COVID-19) - Randomised Controlled Trial, phase III - AZIQUINE-ICU-25032020
adacní fond Donatio intensivistam0 个研究点目标入组 240 人开始时间: 2020年4月8日最近更新:
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
- 240
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
- •1) adult (>18 years)
- •2) within 24 hours of admission to intensive care unit
- •3) proven or suspected COVID-19 infection
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1) Symptoms of febrile disease for =1 week at enrolement
- •2) Pregnancy or inability/unwillingness to perform pregnancy test at and 28 days after enrolment
- •3) Treatment limitations in place or moribund patients
- •4) Allergy, intolerance or contraindication to any study drug, incl. long QT syndromes, myasthenia gravis, allergies or known deficiency of glucose-6-phosphate dehydrogenase
- •5) Known HIV positivity
- •6) Significant liver disease such as cirrhosis Child-Pugh C or active hepatitis B or C
- •7) Known stage IV chronic kidney disease, on dialysis at enrolment or imminent need of it
- •8) Participation in another outcome-based interventional trial within last 30 days
- •9) Patients taking Hydroxychloroquine for other indication than to treat COVID-19.
- •Criteria for withdrawal from the study:
- •1) Consent withdrawal by study subject
- •2) In case – in the opinion of the investigator – the study procedures are considered unsafe for the study subject or the risks outweigh the potential benefits
研究者
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