Clinical trial NCT04355338: Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil (AVISA)
Official title: Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2 infection
Asymptomatic Infections
Antibodies, Neutralizing
Immunity, Humoral
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2020-04-21
Enrollment: 3520
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Incidence of SARS-CoV-2 infection
timeFrame: 24 months
measure: Incidence of COVID-19
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of hospitalization due to COVID-19
timeFrame: 24 years
measure: Level of neutralizing antibodies
timeFrame: 24 months
measure: Previous SARS-CoV-2 infection
timeFrame: 6 months
Other outcomes:
measure: Incidence of SARS-CoV-2 reinfection
timeFrame: 24 months
measure: Incidence of COVID-19 cases requiring mechanical ventilation
timeFrame: 24 months
measure: Incidence of deaths due to COVID-19
timeFrame: 24 months
measure: Incidence of sequels after COVID-19
timeFrame: 24 months
Locations:
city: Fortaleza
country: Brazil
facility: Universidade Federal do Ceará
state: CE
city: Brasilia
country: Brazil
facility: Universidade de Brasília
state: DF
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
state: MG
city: Cuiabá
country: Brazil
facility: Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso
state: Mount
city: Boa Vista
country: Brazil
facility: Universidade Federal de Roraima - UFRR
state: Roraima
city: Porto Velho
country: Brazil
facility: Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)
state: RO
city: Laranjeiras
country: Brazil
facility: Universidade Federal de Sergipe
state: SE
city: Serrana
country: Brazil
facility: Hospital Estadual de Serrana
state: SP
city: São Paulo
country: Brazil
facility: Faculdade Santa Marcelina
state: SP
city: São José Do Rio Preto
country: Brazil
facility: Faculdade de Medicina de São José do Rio Preto - FAMERP
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Instituto de Infectologia Evandro Chagas - Fiocruz
Study officials:
affiliation: Butantan Institute
name: Fernanda Boulos, MD, PhD
role: STUDY_DIRECTOR
References: