Official Title
Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil
Brief Summary

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.

Detailed Description

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.

Active, not recruiting
COVID-19
Eligibility Criteria

Inclusion Criteria:

- Any sex or age

- Providing informed consent

- Agreement with all study visits, procedure and contacts

Exclusion Criteria:

- Previous suspected or confirmed COVID-19

- Febrile illness in the latest 72 hours

- Olfactory or gustatory dysfunction in the last three months

- Healthcare worker in a service with routine attention to COVID-19 patients

- Any conditions that can might hurdle participant's compliance to the study in tha
opinion of the study team

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Brazil
Locations

Universidade Federal do Ceará
Fortaleza, CE, Brazil

Universidade de Brasília
Brasilia, DF, Brazil

Universidade Federal de Minas Gerais
Belo Horizonte, MG, Brazil

Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso
Cuiabá, Mount, Brazil

Universidade Federal de Roraima - UFRR
Boa Vista, Roraima, Brazil

Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)
Porto Velho, RO, Brazil

Universidade Federal de Sergipe
Laranjeiras, SE, Brazil

Hospital Estadual de Serrana
Serrana, SP, Brazil

Faculdade Santa Marcelina
São Paulo, SP, Brazil

Faculdade de Medicina de São José do Rio Preto - FAMERP
São José Do Rio Preto, São Paulo, Brazil

Instituto de Infectologia Evandro Chagas - Fiocruz
Rio De Janeiro, Brazil

Fernanda Boulos, MD, PhD, Study Director
Butantan Institute

Butantan Institute
NCT Number
Keywords
Covid-19
SARS-CoV-2 infection
Asymptomatic Infections
Antibodies, Neutralizing
Immunity, Humoral
MeSH Terms
Infections
COVID-19