EUCTR2020-001882-36-GR进行中(未招募)1 期
ANTI-INFLAMMATORY CLARITHROMYCIN TO IMPROVE SARS-CoV-2 (COVID-19) INFECTION EARLY: THE ACHIEVE OPEN-LABEL NON-RANDOMIZED CLINICAL TRIA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 90
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
- •Age =18 years
- •Male of female gender
- •Written informed consent provided by the patients or by a first-degree relative in case of patients unable to consent
- •In case of women, unwillingness to remain pregnant during the study period achieved either by their partner using condom or by themselves using oral contraceptives.
- •Confirmed infection by SARS-CoV-2 virus
- •Infection of the upper respiratory tract or of the lower respiratory tract
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Age below 18 years
- •Denial of written informed consent
- •Presence of severe respiratory failure
- •Intake of any macrolide for the current episode of infection under study
- •Intake of hydroxychloroquine or chloroquine phosphate.
- •Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 3 days
- •Neutropenia defined as an absolute neutrophil count below 1,000/mm3
- •Presence of any contraindications for the study drugs as stated in local label information
- •QTc interval at rest ECG =500 msec or history of known congenital long QT syndrome
- •Pregnancy or lactation
研究者
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