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临床试验/EUCTR2020-003363-25-DK
EUCTR2020-003363-25-DK进行中(未招募)1 期

Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia: the COVID STEROID 2 trial - COVID STEROID 2

Department of Intensive Care, Rigshospitalet0 个研究点目标入组 1,000 人开始时间: 2020年7月17日最近更新:
适应症
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
1,000

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

  • All the following criteria must be fulfilled:
  • - Aged 18 years or above AND
  • - Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND
  • - Use of one of the following:
  • Invasive mechanical ventilation OR
  • Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR
  • Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system
  • 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 400
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 600

排除标准

  • We will exclude patients who fulfil any of the following criteria:
  • - Use of systemic corticosteroids in doses higher than 6 mg dexamethasone equivalents for other indications than COVID-19
  • - Use of systemic corticosteroids for COVID-19 for 5 days or more
  • - Invasive fungal infection
  • - Active tuberculosis
  • - Fertile woman (< 60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
  • - Known hypersensitivity to dexamethasone
  • - Previously randomised into the COVID STEROID 2 trial
  • - Informed consent not obtainable

研究者

发起方
Department of Intensive Care, Rigshospitalet

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