Covid-19 Data Analyses in Brazil

NCT06652451 | Completed

• 1 other identifier: D7000R00020
• Study Type: observational
• Target: 361,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid

Keywords

Covid

Outcome Measures

Primary Outcomes (2)

• Hospitalization

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

  through study completion, an average of 1 year

• Incidence of hospital mortality

  Evaluate the hospital mortality rate due to covid

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population included in this study are hospitalized patients with COVID-19 registered in the SRAG and SIH databases; representative of a significant sample of individuals present in the public health registry system in Brazil.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

São Paulo, Brazil

Location

Related Links

• CSR Synopsis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 22, 2024
• Study Start: November 12, 2024
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

BR (1)