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临床试验/NCT04355871
NCT04355871已完成不适用

Characteristics and Predictors of Death Among Hospitalized Patients With COVID-19 in Spain

Fundacion SEIMC-GESIDA128 个研究点 分布在 1 个国家目标入组 4,035 人开始时间: 2020年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,035
试验地点
128
主要终点
Overall mortality

研究概览

简要总结

COVID-19@Spain is a retrospective cohort study that aims to determine the clinical characteristics of hospitalized patients with COVID-19 in Spain and to identify prognostic factors of mortality and the need for mechanical ventilation

详细描述

COVID-19@Spain is a retrospective cohort study of patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The Ethics Committee for Research with Medicines of Hospital General Universitario Gregorio Marañón approved the study and waived informed consent for the collection of clinical data.

Investigators from participating centers were asked to include the first consecutive hospitalized patients (up to 100) meeting the study criteria from the start of the epidemic until March 17, 2020.

The data source was the electronic medical records. All data were entered directly by personnel at each institution using an online case report form (CRF), that satisfied local requirements of data confidentiality.

The variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, and the RT-PCR cycle threshold (Ct) of the confirmatory gene. We also registered demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results, chest X-ray findings at baseline and during follow-up, complications during hospitalization, medications with potential activity against COVID-19, and supportive treatments including oxygen therapy, admission to intensive care unit (ICU), mechanical ventilation (intubation), and use of adjuvant anti-inflammatory medications such as tocilizumab and systemic corticosteroids. Drug-related adverse events of medications for COVID-19 needing discontinuation were also recorded. The clinical status of the patients as of April 17, 2020, was categorized as discharged alive (with the date of discharge), alive and currently hospitalized, and death (with the date of death).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay
  • Hospital admission

排除标准

  • 未提供

结局指标

主要结局

Overall mortality

时间窗: 28 days

次要结局

  • Mechanical ventilation(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (128)

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