跳至主要内容
临床试验/EUCTR2020-001934-37-ES
EUCTR2020-001934-37-ES进行中(未招募)1 期

SE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTION (GLUCOCOVID). Pragmatic trial inserted in real practice during a pandemic COVID-19 - USE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTIO

IDIVAL Instituto de Investigación Sanitaria Valdecilla0 个研究点目标入组 200 人开始时间: 2020年5月8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
200

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

  • - Patients admitted to hospital with Covid-19, confirmed by microbiological tests or compatible clinical manifestations, with exclusion of other infections.
  • - Age: 18-85 years old.
  • - Time of evolution: more than 7 days since the beginning of symptoms.
  • - Evidence of inflammation, defined by: Lung infiltrates + Gas exchange disturbance: PaO2 < 65 or Sat<93% (breathing air), or PAFI <300, or SAFI <440, or BCRSS =2 + Elevated biomarkers: PCR >15, or DD>800, or Ferritin >1000, or IL6>20
  • - Absence of bacterial infection or other disease that explains the lung disorder.
  • - Verbal informed consent, which will be recorded in history.
  • 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 120
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 80

排除标准

  • - Refusal to participate
  • - Pregnancy
  • - Established indication for mechanical ventilation, non-invasive ventilation or ICU admission
  • - Immunosuppression
  • - Chronic renal failure on dialysis

研究者

发起方
IDIVAL Instituto de Investigación Sanitaria Valdecilla

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