跳至主要内容
临床试验/NCT06652451
NCT06652451已完成不适用

Covid-19 Data Analyses in Brazil. Retrospective Study Using an Open Data Plataform (DataSUS) to Describe and Analyze Patient Characteristics and Covid-19 Outcomes in Brazil.

AstraZeneca1 个研究点 分布在 1 个国家目标入组 361,000 人开始时间: 2024年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
361,000
试验地点
1
主要终点
Hospitalization

研究概览

简要总结

This descriptive study aims to describe the Brazilian scenario of patients hospitalized due to COVID-19 and to analyze the impact of COVID-19 on the Brazilian public health system. Data will be extracted from the largest secondary database of the Brazilian public health system, DATASUS ("Departamento de Informática do Sistema Único de Saúde"), responsible for collecting, processing, analyzing and disseminating health information and statistics in the country. The analysis, performed only on patients hospitalized during the hospitalization episode, will also evaluate the impact of vaccination against COVID-19 on the immunocompromised population compared to the general population.

详细描述

This is an observational, retrospective, descriptive study based on a secondary database from the Brazilian public health system. Data were collected from three public databases in a large system (DATASUS). These databases are SRAG ("Síndrome Respiratória Acuta"), SIH ("Sistema de Informação Hospitalar"). All data collected are de-identified, which does not allow the identification of sensitive data of participants. The population of this study would be representative of a significant sample of individuals present in the health records system registered with COVID-19. The data included in this study were acquired between January 2021 and December 2023. This analysis will not include data from specific vaccine brands. The data described refer only to the episode of hospitalization related to COVID-19. The primary objective is to describe the demographic and clinical characteristics of individuals hospitalized for COVID-19 between January 2021 and December 2023, stratified by underlying CI, number of vaccine doses received, age, and period of the predominant variant.

As a secondary objective, it is to describe in-hospital mortality due to COVID-19 among individuals hospitalized for COVID-19 between January 2021 and December 2023, stratified by underlying CI, number of non-CI comorbidities, number of vaccine doses received, age, and period of the predominant variant. And also as an exploratory objective, it is expected to describe the use of hospital healthcare resources (HCRU) and the costs associated with hospitalizations related to COVID-19 between January 2021 and December 2023.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All individuals with COVID-19-related hospitalization. Individuals aged ≥18 years at the time of entry into the database.

排除标准

  • Hospitalized patients with incomplete or missing data related to data linked in DATASUS.

结局指标

主要结局

Hospitalization

时间窗: through study completion, an average of 1 year

Descriptive statistics of individuals with COVID-19-related hospitalization for age (mean, SD), age groups (≥18\<64, 65-69, 70-79, 80+);

Incidence of hospital mortality

时间窗: through study completion, an average of 1 year

Evaluate the hospital mortality rate due to covid

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验