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This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.
This is an observational longitudinal study to assess incidence of SARS-CoV-2 infection in Brazil. The study sample is stratified in nine age groups according decades of life, equally distributed in both sexes, with an expected incidence of 10%, at least, during the study period of 24 months. For the first age groups, (0-9, 10-19 and 20-29 years), sample was calculated with the minimum expected incidence of COVID-19 among infected, regardless severity, is 10%. For the latest age groups (30-39, 40-49, 50-59, 60-69, 70-79 and 80+), the sample was calculated with the expected minimum incidence of hospitalization due to COVID-19 according to estimates per age group reported by Verity R et al. https://doi.org/10.1016/S1473-3099(20)30243-7 After the consent procedure, all participants will have a short interview, a IgG/IgM SARS-CoV-2 rapid test and a blood withdrawal to obtain serum for neutralizing antibodies. These procedures will be repeated every four weeks until the end of the study. Individuals with symptoms compatible will be followed-up to confirm COVID-19 diagnosis as well as to assess severity, need for hospitalization and assisted ventilation, sequels, and eventual reinfection. Levels of neutralizing antibodies and other immune markers will be prospectively assessed in all infected participants, either asymptomatic and symptomatic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0-9 years | Participants aging 0-9 years | ||
| 10-19 years | Participants aging 10-19 years | ||
| 20-29 years | Participants aging 20-29 years | ||
| 30-39 years | Participants aging 30-39 years | ||
| 40-49 years | Participants aging 40-49 years | ||
| 50-59 years | Participants aging 50-59 years | ||
| 60-69 years | Participants aging 60-69 years | ||
| 70-79 tears | Participants aging 70-79 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SARS-CoV-2 infection | Number of cases with serological/virological diagnosis for SARS-Co-2 infection | 24 months |
| Incidence of COVID-19 | Number of cases of symptomatic SARS-CoV-2 infection | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hospitalization due to COVID-19 | Number of cases of hospitalization due to symptomatic SARS-Co-2 infection | 24 years |
| Level of neutralizing antibodies | Level of neutralizing antibodies in participants with SARS-Co-2 infection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SARS-CoV-2 reinfection | Number of a new SARS-CoV-2 infection in an individual with a proven previous infection | 24 months |
| Incidence of COVID-19 cases requiring mechanical ventilation | Number of COVID-19 cases requiring mechanical ventilation |
Inclusion Criteria:
Exclusion Criteria:
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The sample size will be equally distributed in ten different cities of Brazil. Then, each site will have same representation of each age group. Participants can be selected from other ongoing community-based studies conducted in the site and from community in general. Balance of participant according to sex is recommended to the sites in all age group.
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda Boulos, MD, PhD | Butantan Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal do Ceará | Fortaleza | Ceará | 60430-160 | Brazil | ||
| Universidade de Brasília |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D058345 | Asymptomatic Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Serum
| 80+ years | Participants aging 80 years or more |
| 24 months |
| Previous SARS-CoV-2 infection | Positive serology for SARS-Co-2 infection at baseline | 6 months |
| 24 months |
| Incidence of deaths due to COVID-19 | Number of deaths due to COVID-19 | 24 months |
| Incidence of sequels after COVID-19 | Number and description of sequels attributed to COVID-19 | 24 months |
| Brasília |
| Federal District |
| 71691-082 |
| Brazil |
| Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | 30750-140 | Brazil |
| Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso | Cuiabá | Mount | 78048-610 | Brazil |
| Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM) | Porto Velho | Rondônia | 78918-791 | Brazil |
| Universidade Federal de Roraima - UFRR | Boa Vista | Roraima | 69304-000 | Brazil |
| Universidade Federal de Sergipe | Laranjeiras | Sergipe | 49170-000 | Brazil |
| Faculdade de Medicina de São José do Rio Preto - FAMERP | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Faculdade Santa Marcelina | São Paulo | São Paulo | 08270-140 | Brazil |
| Hospital Estadual de Serrana | Serrana | São Paulo | 14150-000 | Brazil |
| Instituto de Infectologia Evandro Chagas - Fiocruz | Rio de Janeiro | 21710-232 | Brazil |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D058070 | Asymptomatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |