Covid19SARS-BrazilNCT04479488
Brazilian Registry for Clinical Presentation of Individuals With COVID-19 (SARS-Brazil)
An observational study of Covid19 and SARS-CoV Infection, run by Hospital Israelita Albert Einstein at 14 sites in Brazil.
Trial summary
This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection. The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Hospital admission and Non-hospitalization procedures
- How many people
- 1,587 participants
- Where
- 14 sitesBrazil
- Study dates
- 27 Jul 2020to 30 Dec 2022
- How long will I take part?
- 2 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SARS-Brazil Registry is designed as multicenter observational cohort of adult patients (≥18 years old), that are confirmed or suspected SARS-CoV-2 infection in Brazilian hospitals.
Who may be able to join
- Adult patients (≥18 years);
- Confirmed or suspected SARS-CoV2 infection
Who cannot join
- Patient who expressed opposition to participation in the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Brazil14 sites
Hospital de Emergencia Dr. Daniel Houly
Arapiraca, Alagoas
Alencar Serviços Médicos Ltda
Barbalha, Ceará
Fundação Educacional Lucas Machado
Belo Horizonte, Minas Gerais
Fundação Hopitalar São Francisco de Assis
Belo Horizonte, Minas Gerais
Hospital Giselda Trigueiro
Natal, Rio Grande do Norte
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul
Hospital Santa Lucia
Poços de Caldas, Minas Gerais
Hospital Municipal Vila Santa Catarina
São Paulo
Hospital São Camilo - Ipiranga
São Paulo
Hospital São Camilo - Pompéia
São Paulo
Hospital Estadual Jayme dos Santos Neves
Serra, Espírito Santo
Hospital Santa Rita de Cássia
Vitória, Espírito Santo
Universidade Federal da Bahia
Vitória da Conquista, Estado de Bahia
Santa Casa de Votuporanga
Votuporanga, São Paulo
About this study
Official title: Brazilian COVID-19 Registry for Clinical Presentation of Individuals With COVID-19: a National, Multicentre, Prospective Observational Study (SARS-Brazil)
This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection.
The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients.
A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.
Read the detailed description
Registry on characteristics and outcomes of hospitalized and non-hospitalized SARS-CoV2 infected patients in Brazil.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Hospital admission, Non-hospitalization procedures
- Keywords
- COVID-19, SARS-CoV2 infection, Intensive care unit, Oxygen supplementation, Invasive ventilation, Mortality
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital admissionOther
Usual care.
Non-hospitalization proceduresOther
Usual care.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients | Patient who are suspected or confirmed SARS-CoV2 infection need hospitalization. Receives: Other: Hospital admission | |
| Non-hospitalized patients | Patient who are suspected or confirmed SARS-CoV2 infection non-hospitalized. Receives: Other: Non-hospitalization procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality rates at 60 days
Measured: 60 Days
Secondary outcomes (5)
Incidence and course of symptoms of COVID-19 infection
To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days
Measured: 60 Days
Hospitalizations
Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)
Measured: 60 Days
Oxygen supplementation
Rate of patients requiring oxygen therapy
Measured: 60 Days
Use of invasive mechanical ventilation
Rate of patients requiring invasive mechanical ventilation
Measured: 60 Days
Intensive care unit length of stay
ICU length of stay
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start27 Jul 2020
- Primary completion30 Mar 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,587 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Otávio Berwanger, PhD, Study director, Hospital Israelita Albert EinsteinHenrique A Fonseca, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479488
- Sponsor's protocol ID
- 30047620.3.0000.0071
- Acronym
- SARS-Brazil
- Status last verified
- Dec 2022
- First submitted
- 13 Jul 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fonseca HAR, Pereira AJ, Nawa RK, Sant'Anna VAR, Almeida TF, Guimaraes HP, Tognon AP, Marques LM, Silva LSCD, Bittencourt RS, Gomes CP, Martins PA, Oliveira AL, Milan EP, Dall'Orto FTC, Hoffman Filho CR, Almeida G, Hohmann FB, Moia DDF, Piano LPA, Machado FP, Soares RVP, Damiani LP, Assis SRL, Amaro Junior E, Rizzo LV, Berwanger O. Mortality, hospitalizations, and persistence of symptoms in the outpatient setting of the first COVID-19 wave in Brazil: results of SARS-Brazil cohort study. Einstein (Sao Paulo). 2024 Aug 9;22:eAO0652. doi: 10.31744/einstein_journal/2024AO0652. eCollection 2024.
PubMed 39140573
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian COVID-19 Registry for Clinical Presentation of Individuals With COVID-19: a National, Multicentre, Prospective Observational Study (SARS-Brazil)
- ClinicalTrials.gov ID
- NCT04479488
- Acronym / sponsor ID
- SARS-Brazil / 30047620.3.0000.0071
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- COVID-19, SARS-CoV2 infection, Intensive care unit, Oxygen supplementation, Invasive ventilation, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,587 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Jul 2020 (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 is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection.
The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients.
A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.
Detailed description
Registry on characteristics and outcomes of hospitalized and non-hospitalized SARS-CoV2 infected patients in Brazil.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients | – | Other: Hospital admissionPatient who are suspected or confirmed SARS-CoV2 infection need hospitalization. |
| Non-hospitalized patients | – | Other: Non-hospitalization proceduresPatient who are suspected or confirmed SARS-CoV2 infection non-hospitalized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SARS-Brazil Registry is designed as multicenter observational cohort of adult patients (≥18 years old), that are confirmed or suspected SARS-CoV-2 infection in Brazilian hospitals.
Key inclusion criteria (2 listed)
- Adult patients (≥18 years);
- Confirmed or suspected SARS-CoV2 infection
Key exclusion criteria (1 listed)
- Patient who expressed opposition to participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital admissionUsual care. | Other | Hospitalized patients |
| Non-hospitalization proceduresUsual care. | Other | Non-hospitalized patients |
Primary outcome
All-cause mortality
Time frame: 60 Days
All-cause mortality rates at 60 days
5 secondary outcomes
Incidence and course of symptoms of COVID-19 infection
Time frame: 60 Days
Hospitalizations
Time frame: 60 Days
Oxygen supplementation
Time frame: 60 Days
Use of invasive mechanical ventilation
Time frame: 60 Days
Intensive care unit length of stay
Time frame: 60 Days
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 9 Mar 2023.
- Derived from this study: PubMed 39140573Fonseca HAR, Pereira AJ, Nawa RK, Sant'Anna VAR, Almeida TF, Guimaraes HP, Tognon AP, Marques LM, Silva LSCD, Bittencourt RS, Gomes CP, Martins PA, Oliveira AL, Milan EP, Dall'Orto FTC, Hoffman Filho CR, Almeida G, Hohmann FB, Moia DDF, Piano LPA, Machado FP, Soares RVP, Damiani LP, Assis SRL, Amaro Junior E, Rizzo LV, Berwanger O. Mortality, hospitalizations, and persistence of symptoms in the outpatient setting of the first COVID-19 wave in Brazil: results of SARS-Brazil cohort study. Einstein (Sao Paulo). 2024 Aug 9;22:eAO0652. doi: 10.31744/einstein_journal/2024AO0652. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
Otávio Berwanger, PhD study director
Hospital Israelita Albert Einstein
Henrique A Fonseca, PhD principal investigator
Hospital Israelita Albert Einstein
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by Hospital Israelita Albert Einstein at 14 sites 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 2 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
All-cause mortality (time frame: 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479488, which also lists 1 linked publication.
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 9 Mar 2023.