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Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil
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.
Age
All ages
Sex
ALL
Healthy Volunteers
Yes
Universidade Federal do Ceará
Fortaleza, Ceará, Brazil
Universidade de Brasília
Brasília, Federal District, Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso
Cuiabá, Mount, Brazil
Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)
Porto Velho, Rondônia, Brazil
Universidade Federal de Roraima - UFRR
Boa Vista, Roraima, Brazil
Universidade Federal de Sergipe
Laranjeiras, Sergipe, Brazil
Faculdade de Medicina de São José do Rio Preto - FAMERP
São José do Rio Preto, São Paulo, Brazil
Faculdade Santa Marcelina
São Paulo, São Paulo, Brazil
Hospital Estadual de Serrana
Serrana, São Paulo, Brazil
Start Date
October 25, 2020
Primary Completion Date
October 30, 2021
Completion Date
October 30, 2024
Last Updated
February 6, 2025
3,520
ACTUAL participants
Lead Sponsor
Butantan Institute
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287