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临床试验/NCT04362943
NCT04362943已完成不适用

Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults

Complejo Hospitalario Universitario de Albacete1 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2020年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
576
试验地点
1
主要终点
Mortality

研究概览

简要总结

Retrospective clinical-epidemiological study aimed at characterizing COVID-19 disease in adults older than 70 years, hospitalized in the "Perpetuo Socorro" Hospital of Albacete (Spain) from 09/03/2020 until 20/04/2020. Secondary objectives will be to analyze clinical-epidemiological characteristics of COVID-19 patients treated with Baricitinib or Anakinra, and to describe the efficacy and secondary effects of those drugs.

详细描述

Design: Retrospective postauthorization study. Registry study. Setting: COVID Unit, "Perpetuo Socorro" Hospital of Albacete (Spain). Participants: Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020. All patients will be included without exclussion criteria.

Measurements:

  • Age, sex, residency.
  • Functional assessment: Barthel index, Katz index, Functional Ambulation Classification.
  • Cognitive assessment: Reisberg´s Global Deteriorating Scale.
  • Comorbidity: Charlson index, disease count.
  • Chronic medicines consumed.
  • Disease related symptoms.
  • Lab determinations: White cells, neutrophyl count, lymphocyte count, platelets, haemoglobin, INR, fibrinogen, D-Dimer, Ferritin, CRP, IL-6, urea, creatinin, AST, ALT, CK.
  • Thorax X-ray findings: COVID affectation, severity, pleural effusion, heart failure signs, pneumothorax.
  • Drugs used during hospitalization, number of days of treatment and total doses: Anakinra, Baricitinib, Glucocorticoids, Antivirals (Lopinavir/Ritonavir, Emtricitabina/Tenofovir), Azitromycin, Ceftriaxone, Hidroxychloroquin.
  • Geriatric syndroms: Delirium, immobility, dysphagia, pressure ulcers.
  • Outcomes: Mortality at discharge, institucionalización at discharge, length of stay, change in lab results, change in X-ray results, change in function at discharge.

Registry procedures: Medical chart review by trained Geriatricians, pharmachological chart review by expert Pharmacists, X-ray review by trained radiologists. All data will be included in an anonimyzed database for further analysis by investigators, and supervised by Principal Investigator.

Regulatory status: The protocol was approved by the Ethics review committee of Albacete (number 2020-21 from 20/04/2020) and by the Spanish Medicines Agency (AEMPS) who gave a "Postauthorization Study" classification (number PAS-BAR-2020-04. 20/04/2020).

研究设计

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

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020, in the "Perpetuo Socorro" Hospital of Albacete (Spain).

排除标准

  • 未提供

研究组 & 干预措施

Complete sample

Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 in the "Perpetuo Socorro" Hospital of Albacete (Spain)

干预措施: Baricitinib or Anakinra (Drug)

Baricitinib

Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib.

干预措施: Baricitinib or Anakinra (Drug)

Anakinra

Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra.

干预措施: Baricitinib or Anakinra (Drug)

结局指标

主要结局

Mortality

时间窗: 1 month

Mortality for all causes

次要结局

  • Disability changes(1 month)
  • lymphocyte count changes(1 month)
  • C-Reactive Protein changes(1 month)
  • Ferritin changes(1 month)
  • Ambulation changes(1 month)
  • D-Dimer changes(1 month)
  • X-ray changes(1 month)

研究者

发起方
Complejo Hospitalario Universitario de Albacete
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Abizanda

Prof.

Complejo Hospitalario Universitario de Albacete

研究点 (1)

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