Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
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
- 否
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
Pedro Abizanda
Prof.
Complejo Hospitalario Universitario de Albacete
