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临床试验/EUCTR2020-001882-36-GR
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

Hellenic Institute for the Study of Sepsis0 个研究点目标入组 90 人开始时间: 2020年4月30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)
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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