Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652451
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Covid-19 Data Analyses in Brazil
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAVO
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None