Randomized open label trial assessing efficacy and safety of hydroxychloroquine plus azithromycin versus hydroxychloroquine for hospitalized patients with COVID-19

niversity Hospital of Montpellier0 个研究点目标入组 120 人开始时间: 2020年4月3日最近更新: 2021年4月12日

适应症

试验速览

暂无简介。

•Written informed consent
•Adult under 75 years old
•- documented infection with SARS CoV 2 (positive virological test) within 96 h before randomization
•- COVID-19 symptoms occurring within 10 days of randomization
•- Radiographic or tomography signs of pneumonia (infiltrates)
•- Hospitalized patient (outside the intensive care unit) with either a moderate clinical form (defined as not requiring oxygen therapy at the time of randomization), or a severe non-resuscitative clinical form (defined as requiring oxygen therapy by nasal tube or mask with an oxygen flow <6 l / min)
•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 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•-- admission to intensive care at the time of selection
•- contraindication to IMPs
•Oxygen saturation rate low defined as
•- <90% in ambient air
•- <94% with oxygen therapy ? 3 l / min
•need for oxygen therapy= 6 l / min or mechanical ventilation
•ALT or ASAT rate> 5 LSN
•renal failure (DGFe <30 ml / min) or dialysis
•Pregnancy or breastfeeding
•Retinopathy
•Known G6PD deficiency
•History of heart rhythm disorder or QT prolongation
•Prolongation of the QT space on an ECG dating at the time of selection of less than 24 hours: QTc> 450 ms
•- hydoxychloroquine contra indication (citalopram, escitalopram, hydroxyzine, domperidone and piperaquine);
•- Taking drugs known to prolong the QT interval or likely to induce a cardiac arrhythmia such as anti-arrhythmics of class IA and III, tricyclic antidepressants, antipsychotics
•- Participation in another clinical trial with an experimental treatment of COVID-19
•- A Concomitant treatment with possible action on SARS-CoV-2 is not authorized if it is administered less than 24 hours before the administration of the IMP

发起方

niversity Hospital of Montpellier