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临床试验/EUCTR2015-002340-14-FR
EUCTR2015-002340-14-FR进行中(未招募)1 期

Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia Coronavirus COVID-19 (REMAP-CAP-COVID-19) - REMAP-CAP

niversity Medical Center Utrecht0 个研究点目标入组 4,000 人开始时间: 2020年3月27日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
4,000

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

  • 1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with
  • a. symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND
  • b. Radiological evidence of new onset infiltrate of infective origin (in patients with pre-existing radiological changes, evidence of new infiltrate)
  • 2. Up to 48 hours after ICU admission, receiving organ support with one or more of:
  • a. Non-invasive or invasive ventilatory support;
  • b. Receiving infusion of vasopressor or inotropes or both
  • 3. Proven or suspected COVID-19 infection
  • Precisions for the French part :
  • 1.Patients under guardianship or curatorship
  • 2.Informed written consent of the patient or a legally authorized close relative, or emergency procedure.
  • In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.
  • 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 2000
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2000

排除标准

  • 1.Non COVID-19 pneumonia
  • Precisions for the French part :
  • 1.Patients under guardianship or curatorship
  • 2.Informed written consent of the patient or a legally authorized close relative, or emergency procedure.
  • In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.

研究者

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