NL-OMON49040已完成不适用
A phase 1b, randomized, double-blinded, placebo-controlled study of hydroxychloroquine in outpatient adults with COVID-19 - EFC16855
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Participants * 18 years and * 80 years of age
- •- Participants with a diagnosis of COVID-19 via an approved or authorized
- •molecular test
- •- Presence of symptoms compatible with COVID-19 at the time of screening
- •- Time between onset of symptoms and first dose of hydroxychloroquine or
- •placebo is 96 hours or less
- •- Female participants must use an acceptable birth control method, as specified
- •by each site and country
排除标准
- •- COVID-19 disease requiring the use of suplemental oxygen
- •- Electrocardiogram (ECG) tracing with QTc interval > 450 ms for men, > 470 ms
- •for women (Fridericia algorithm recommended)
- •- Bradycardia (< 50 beats/min)
- •- History of cardiac disease (e.g. congestive heart failure, myocardial
- •infarction)
- •- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •- Women who are pregnant or breastfeeding
- •- Concurrent antimicrobial therapy
- •- Hydroxychloroquine use within 2 months before enrollment
- •- Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline
- •- History of severe skin reactions such as Sevens-Johnson syndrome and toxic
- •- History of retinopathy
- •- Concurrent use of antiepileptic medications
- •- History of arrythmia, concurrent use of anti-arrhythmic drugs, or family
- •history of sudden
- •cardiac death
- •- History of severe renal disease (treatment with dialysis or phosphate
- •binders) or hepatic
- •- History of organ transplant or stem cell transplant
- •- Body weight below 60 kg
研究者
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