NL-OMON49317已完成不适用
An open label randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19 - ARCHAIC studie
niversitair Medisch Centrum Utrecht0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients (>=18 years of age) admitted to the hospital with confirmed COVID-19
- •and not needing admission to MC or ICU
- •Patient has moderate to severe COVID-19. This will be defined as patients with
- •NEWS-2 score <= 5
排除标准
- •- Severe Covid-19 defined as NEWS-2 score >5 or admission to the ICU needing
- •ventilation or pressure support.
- •- Contra-indications for hydroxychloroquine or chloroquine
- •- Known pregnancy, not using adequate contraception and having a chance of
- •being pregnant (unless a negative pregnancy test is documented).
- •- Unable to take oral medication (chloroquine and hydroxychloroquine can be
- •administered through tube feeding which is considered oral administration)
- •- Identified allergies to 4-aminoquinoline
- •- Severe diseases of the blood system
- •- 6-phosphate dehydrogenase deficiency
- •- History of acute myocardial infarction, unstable angina pectoris, severe
- •arrhythmia (frequent ventricular, ventricular tachycardia, ventricular
- •fibrillation) in recent 6 months; New York Heart Association (NYHA) level III-IV
- •- Corrected QT interval (QTc) >= 500ms on baseline electrocardiogram.
- •- Uncorrected severe hypokalaemia (< 2,5 mmol/l) or uncorrected severe
- •hypomagnesemia (< 0.6 mmol/l)
- •- Pancreatitis
- •- Refusal to participate expressed by patient or legally authorized
- •representative if they are present
研究者
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