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NCT Number: NCT04355338

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of SARS-CoV-2 infection

    Time frame: 24 months

    Number of cases with serological/virological diagnosis for SARS-Co-2 infection

  2. Incidence of COVID-19

    Time frame: 24 months

    Number of cases of symptomatic SARS-CoV-2 infection

Secondary outcomes

  1. Incidence of hospitalization due to COVID-19

    Time frame: 24 years

    Number of cases of hospitalization due to symptomatic SARS-Co-2 infection

  2. Level of neutralizing antibodies

    Time frame: 24 months

    Level of neutralizing antibodies in participants with SARS-Co-2 infection

  3. Previous SARS-CoV-2 infection

    Time frame: 6 months

    Positive serology for SARS-Co-2 infection at baseline

Other outcomes

  1. Incidence of SARS-CoV-2 reinfection

    Time frame: 24 months

    Number of a new SARS-CoV-2 infection in an individual with a proven previous infection

  2. Incidence of COVID-19 cases requiring mechanical ventilation

    Time frame: 24 months

    Number of COVID-19 cases requiring mechanical ventilation

  3. Incidence of deaths due to COVID-19

    Time frame: 24 months

    Number of deaths due to COVID-19

  4. Incidence of sequels after COVID-19

    Time frame: 24 months

    Number and description of sequels attributed to COVID-19

Sponsors and collaborators

Lead sponsor

Butantan Institute

Other Gov

Registry information

Official study title

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

Acronym: AVISA

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Apr 21, 2020
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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