EUCTR2020-001605-23-ES进行中（未招募）1 期
Effectiveness of the combined treatment with hydroxycloroquine and azithromycin vs lopinavir/ritonavir + hydroxycloroquine in hospitalized patients with confirmed COVID-19 infection
Basque Health Service0 个研究点目标入组 108 人开始时间: 2020年5月31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
- 108
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
- •- RT-PCR confirmed.
- •- 18-80 years.
- •- Pneumonia confirmed by Rx chest: pneumonia CURB<=1 y Sat O2>92%
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •->7 days from the onset of symptoms
- •- Severe disease Covid 19, defined by any of the following: FR<30 per min, sat O2 breathing ambient air<92%, sepsis or septic shock
- •- Pregnancy
- •- Kidney or liver terminal disease
- •- History of allergy to hydroxycloroquine and/or azithromycin
- •- Patients presenting contraindications to study drugs
- •- Hyprsensitivity to azithromycin, erythromycin, to any other macrolide or ketolide antibioticor any of the following excipients: pregelatinized corn starch, sodium crocarmellose, sodium laurel sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose, titanium dioxide (E-171), triacetin.
- •- Electrocardiographic abnormalities: treatment is not started or discontinued if QTc (Brazett formula)>500ms and risk-benefit is valued between a460-500 ms. Does not start treatment if ECG shows changes in channel-patties and risk-benefit is valued if there are other abnormalities.
- •- Patients with glucose 6 phosphate dehydrogenase deficiency.
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