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临床试验/NCT05792891
NCT05792891已完成不适用

Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19.

Regina Elena Cancer Institute2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年12月22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
150
试验地点
2
主要终点
Develop general guidelines for clinical care of frail patients

研究概览

简要总结

The COVID-19 pandemic started in December 2019 in Wuhan, the Chinese province of Hubei. Compared to the period of the first epidemic wave (March to May 2020), in the period of the second epidemic wave (October 2020 to July 2021), deceased people have a more significant clinical complexit, as demonstrated by the higher number of comorbidities.The need to allocate significant amounts of healthcare resources to the COVID-19 emergency, deferral of routine healthcare visits, and invitation to avoid medical controls, if not strictly necessary, may have led to interruptions of disease management undersupply of chronic treatments. Consequently, the health status of patients with chronic pathologic conditions have worsened during and beyond the crisis. Patients with cancer, autoimmune disease, and immune deficiencies represented populations with varying immunocompetence, which made translate into higher susceptibility to SARS-CoV-2 and, for this reason, we defined them as frail populations.The main goal of the study was to propel the field of COVID-19 impact on particularly vulnerable categories of patients. The findings of this study could aid in determining the conditions under which healthcare organizations must operate in the event of a pandemic in order to protect patient's rights to care.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Written informed consent for participation in the study
  • In the period between April 1, 2021, and September 31, 2022, all COVID-19 positive frail patients identified by molecular swabs taken at participating institutions were included in the study; ii) on a quarterly basis, a cohort of equal numbers of COVID-19 negative frail patients wre identified and paired by disease , gender, and age.

排除标准

  • No exclusion criteria were identified

结局指标

主要结局

Develop general guidelines for clinical care of frail patients

时间窗: 18 months

Presence or not of SARS-COV2 infection Presence of specific tumor or HIV-1 infection or psoriasis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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