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

COVID-19 Clinical Trial

— AVISA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04355338
• Other study ID #: COV-01-IB
• Status: Active, not recruiting
• Start date: October 25, 2020
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 3520
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infections

Locations

Country	Name	City	State
Brazil	Universidade Federal de Minas Gerais	Belo Horizonte	MG
Brazil	Universidade Federal de Roraima - UFRR	Boa Vista	Roraima
Brazil	Universidade de Brasília	Brasilia	DF
Brazil	Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso	Cuiabá	Mount
Brazil	Universidade Federal do Ceará	Fortaleza	CE
Brazil	Universidade Federal de Sergipe	Laranjeiras	SE
Brazil	Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)	Porto Velho	RO
Brazil	Instituto de Infectologia Evandro Chagas - Fiocruz	Rio De Janeiro
Brazil	Faculdade de Medicina de São José do Rio Preto - FAMERP	São José Do Rio Preto	São Paulo
Brazil	Faculdade Santa Marcelina	São Paulo	SP
Brazil	Hospital Estadual de Serrana	Serrana	SP

Sponsors (1)

Lead Sponsor	Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of SARS-CoV-2 reinfection	Number of a new SARS-CoV-2 infection in an individual with a proven previous infection	24 months
Other	Incidence of COVID-19 cases requiring mechanical ventilation	Number of COVID-19 cases requiring mechanical ventilation	24 months
Other	Incidence of deaths due to COVID-19	Number of deaths due to COVID-19	24 months
Other	Incidence of sequels after COVID-19	Number and description of sequels attributed to COVID-19	24 months
Primary	Incidence of SARS-CoV-2 infection	Number of cases with serological/virological diagnosis for SARS-Co-2 infection	24 months
Primary	Incidence of COVID-19	Number of cases of symptomatic SARS-CoV-2 infection	24 months
Secondary	Incidence of hospitalization due to COVID-19	Number of cases of hospitalization due to symptomatic SARS-Co-2 infection	24 years
Secondary	Level of neutralizing antibodies	Level of neutralizing antibodies in participants with SARS-Co-2 infection	24 months
Secondary	Previous SARS-CoV-2 infection	Positive serology for SARS-Co-2 infection at baseline	6 months