Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Pharmacokinetics of hydroxychloroquine (HCQ)
研究概览
简要总结
To date, no treatment has demonstrated clinical efficacy on COVID 19. However, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. Among these strategies, the use of hydroxychloroquine (HCQ) seems promising. There is very little information on how to precisely administer hydroxychloroquine to patients infected with SARS-CoV-2 in intensive care, which may be responsible for side effects, some of which are potentially serious. In addition, this treatment has a long half-life which increases the risk of accumulation and therefore toxicity. In view of the lack of knowledge on the pharmacokinetic / pharmacodynamic properties of hydroxychloroquine in intensive care patients infected with SARS-CoV-2, we propose to perform a prospective multicenter cohort study in order to collect the biological data necessary for this evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18 years of age and older
- •Patients hospitalized in the intensive care unit infected with CoV-2-SARS for whom a diagnosis of respiratory CoV-2-SARS infection has been made by nasopharyngeal swab or deep respiratory sampling.
- •Patient receiving HCQ treatment as part of care or as part of a clinical trial.
- •Patient affiliated or entitled to a social security scheme
排除标准
- •Hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate.
- •Retinopathies
- •Combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes.
- •Patient with known QT prolongation
- •Known deficit in G6PD
- •Pregnant woman
研究组 & 干预措施
Patients infected by SARS-CoV-2 treated by Hydroxychloroquine
Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine
干预措施: Hydroxychloroquine (HCQ) (Drug)
结局指标
主要结局
Pharmacokinetics of hydroxychloroquine (HCQ)
时间窗: Up to day 21
measured blood concentration by blood sample results.
次要结局
- Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval)(Up to day 21)
- Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ)(Day 1, Day 3, Day 5, Day 7, Day 14, Day 21)
- Pharmacokinetic model(Up to day 21)