Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil (AVISA) (AVISA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19

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.

• Study Type: Observational
• Enrollment (Actual): 3520

Contacts and Locations

• Study Contact: Name: Ricardo Palacios, MD, PhD; Phone Number: +55(11)26279300; Email: ricardo.palacios@butantan.gov.br

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 21710-232
    • Instituto de Infectologia Evandro Chagas - Fiocruz
  • CE
    • Fortaleza, CE, Brazil, 60430-160
      • Universidade Federal Do Ceara
  • DF
    • Brasilia, DF, Brazil, 71691-082
      • Universidade de Brasília
  • MG
    • Belo Horizonte, MG, Brazil, 30750-140
      • Universidade Federal de Minas Gerais
  • Mount
    • Cuiabá, Mount, Brazil, 78048-610
      • Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso
  • RO
    • Porto Velho, RO, Brazil, 78918-791
      • Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)
  • Roraima
    • Boa Vista, Roraima, Brazil, 69304-000
      • Universidade Federal de Roraima - UFRR
  • SE
    • Laranjeiras, SE, Brazil, 49170-000
      • Universidade Federal de Sergipe
  • SP
    • Serrana, SP, Brazil, 14150-000
      • Hospital Estadual de Serrana
    • São Paulo, SP, Brazil, 08270-140
      • Faculdade Santa Marcelina
  • São Paulo
    • São José Do Rio Preto, São Paulo, Brazil, 15090-000
      • Faculdade de Medicina de São José do Rio Preto - FAMERP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort
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
80+ years; Participants aging 80 years or more

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	24 months
Previous SARS-CoV-2 infection	Positive serology for SARS-Co-2 infection at baseline	6 months

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Butantan Institute
• Investigators: Study Director: Fernanda Boulos, MD, PhD, Butantan Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; SARS-CoV-2 infection; Immunity, Humoral; Antibodies, Neutralizing; Asymptomatic Infections
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: COV-01-IB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No