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

NCT04355338 | Completed

• 1 other identifier: COV-01-IB
• Study Type: observational
• Target: 3,520
• Locations: 1 country
• Sites: 11

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2 infection; Asymptomatic Infections; Antibodies, Neutralizing; Immunity, Humoral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Incidence of hospitalization due to COVID-19

  24 years

• Level of neutralizing antibodies

  24 months

• Previous SARS-CoV-2 infection

  6 months

Other Outcomes (4)

• Incidence of SARS-CoV-2 reinfection

  24 months

• Incidence of COVID-19 cases requiring mechanical ventilation

  24 months

• Incidence of deaths due to COVID-19

  24 months

Study Arms (9)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Any sex or age
• Providing informed consent
• Agreement with all study visits, procedure and contacts

You may not qualify if:

• 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

Sponsors & Collaborators

• Butantan Institute: lead

Study Sites (11)

Universidade Federal do Ceará

Fortaleza, Ceará, 60430-160, Brazil

Location

Universidade de Brasília

Brasília, Federal District, 71691-082, Brazil

Location

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30750-140, Brazil

Location

Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso

Cuiabá, Mount, 78048-610, Brazil

Location

Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)

Porto Velho, Rondônia, 78918-791, Brazil

Location

Universidade Federal de Roraima - UFRR

Boa Vista, Roraima, 69304-000, Brazil

Location

Universidade Federal de Sergipe

Laranjeiras, Sergipe, 49170-000, Brazil

Location

Faculdade de Medicina de São José do Rio Preto - FAMERP

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Faculdade Santa Marcelina

São Paulo, São Paulo, 08270-140, Brazil

Location

Hospital Estadual de Serrana

Serrana, São Paulo, 14150-000, Brazil

Location

Instituto de Infectologia Evandro Chagas - Fiocruz

Rio de Janeiro, 21710-232, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

COVID-19; Asymptomatic Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernanda Boulos, MD, PhD

  Butantan Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: October 25, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2024
• Last Updated: February 6, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (11)