CovidBRAVONCT06652451
Covid-19 Data Analyses in Brazil
An observational study of Covid, run by AstraZeneca at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid
- How many people
- 361,000 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Nov 2024to 29 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All individuals with COVID-19-related hospitalization. Individuals aged ≥18 years at the time of entry into the database.
Who cannot join
- Hospitalized patients with incomplete or missing data related to data linked in DATASUS.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Covid
- Keywords
- Covid
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
Descriptive statistics of individuals with COVID-19-related hospitalization for age (mean, SD), age groups (≥18<64, 65-69, 70-79, 80+);
Measured: through study completion, an average of 1 year
Incidence of hospital mortality
Evaluate the hospital mortality rate due to covid
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start12 Nov 2024
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CovidStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 361,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652451
- Sponsor's protocol ID
- D7000R00020
- Acronym
- BRAVO
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06652451
- Acronym / sponsor ID
- BRAVO / D7000R00020
- Conditions
- Covid
- Keywords
- Covid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All individuals with COVID-19-related hospitalization. Individuals aged ≥18 years at the time of entry into the database.
Key exclusion criteria (1 listed)
- Hospitalized patients with incomplete or missing data related to data linked in DATASUS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospitalization
Time frame: 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
Time frame: through study completion, an average of 1 year
Evaluate the hospital mortality rate due to covid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid, run by AstraZeneca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.