Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil (AVISA)
- Conditions
- COVID-19
- Registration Number
- NCT04355338
- Lead Sponsor
- Butantan Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3520
- Any sex or age
- Providing informed consent
- Agreement with all study visits, procedure and contacts
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of SARS-CoV-2 infection 24 months Number of cases with serological/virological diagnosis for SARS-Co-2 infection
Incidence of COVID-19 24 months Number of cases of symptomatic SARS-CoV-2 infection
- Secondary Outcome Measures
Name Time Method Incidence of hospitalization due to COVID-19 24 years Number of cases of hospitalization due to symptomatic SARS-Co-2 infection
Previous SARS-CoV-2 infection 6 months Positive serology for SARS-Co-2 infection at baseline
Level of neutralizing antibodies 24 months Level of neutralizing antibodies in participants with SARS-Co-2 infection
Trial Locations
- Locations (11)
Instituto de Infectologia Evandro Chagas - Fiocruz
🇧🇷Rio De Janeiro, Brazil
Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte, MG, Brazil
Universidade Federal de Sergipe
🇧🇷Laranjeiras, SE, 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
Universidade Federal de Roraima - UFRR
🇧🇷Boa Vista, Roraima, Brazil
Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso
🇧🇷Cuiabá, Mount, Brazil
Universidade de Brasília
🇧🇷Brasilia, DF, Brazil
Universidade Federal do Ceará
🇧🇷Fortaleza, CE, Brazil
Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)
🇧🇷Porto Velho, RO, Brazil
Hospital Estadual de Serrana
🇧🇷Serrana, SP, Brazil