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临床试验/NCT04355338
NCT04355338已完成不适用

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

Butantan Institute11 个研究点 分布在 1 个国家目标入组 3,520 人开始时间: 2020年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,520
试验地点
11
主要终点
Incidence of SARS-CoV-2 infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Incidence of SARS-CoV-2 infection

时间窗: 24 months

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

Incidence of COVID-19

时间窗: 24 months

Number of cases of symptomatic SARS-CoV-2 infection

次要结局

  • Incidence of hospitalization due to COVID-19(24 years)
  • Previous SARS-CoV-2 infection(6 months)
  • Level of neutralizing antibodies(24 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (11)

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