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临床试验/NCT04406038
NCT04406038已完成不适用

A Population-Based Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Saint Petersburg, Russia: Longitudinal Cohort Study

European University at St. Petersburg1 个研究点 分布在 1 个国家目标入组 1,038 人开始时间: 2020年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,038
试验地点
1
主要终点
Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia

研究概览

简要总结

Seroprevalence study of COVID-19 in Saint Petersburg, Russia is a regional longitudinal cohort study aiming to evaluate the spread dynamics of the COVID-19 disease in the population of Saint Petersburg. Clinically asymptomatic adults are sampled from the population using random digit dialing and tested for the presence of SARS-CoV-2-specific antibodies in the blood serum. Data collection and serial sampling of the same individuals spans four weeks and is conducted every two weeks in order to understand both the spread of the virus in the population.

详细描述

At least 1 000 individuals, 18 years old and older, are randomly sampled using random digit dialing from the population of Saint Petersburg, Russia. Random sampling is performed by a survey company on the list of mobile phone numbers with designated geography prefixes of St. Petersburg. The baseline questionnaire for computer-assisted telephone interview includes travel history, medical history, and socio-economic status of the respondents. Sampled individuals are then invited to the clinic for blood sampling, their refusal to participate is recorded. Collected blood samples are used for SARS-CoV-2-specific antibodies testing. Data and sample collection spans four weeks and is conducted every two weeks. Participants complete additional questionnaires in the clinic providing information on medical history, history of allergies, chronic disease, smoking, and medication taken regularly. Contact tracing data and environmental conditions of the household are reсorded.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals sampled from the population of Saint Petersburg, Russia using random digit dialling.
  • Subjects aged 18 and older of both genders.
  • Asymptomatic at the time of blood draw.
  • Written informed consent for a blood draw, SARS-COV-2 antibody test, and data collection.

排除标准

  • Presence of fever or cough or respiratory distress at the time of blood test not attributable to other known chronic disease.
  • Age under
  • Any health condition that may be a contraindication towards blood sampling in out-patient clinic.
  • Residence in Kolpinskiy, Kurortniy, Krasnoselsky, Kronshtadtskiy, Petrodvorcoviy, Pushkinskiy districts of St. Petersburg.

结局指标

主要结局

Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia

时间窗: Measured with two-week (14 days) intervals

Measured by SARS-CoV-2-specific antibodies serial testing and corrected for volunteer bias and test characteristics.

次要结局

  • Immune response dynamics(Measured with two-week (14 days) intervals)
  • Prevalence odds ratios(Measured with two-week (14 days) intervals)

研究者

发起方
European University at St. Petersburg
申办方类型
Other
责任方
Sponsor

研究点 (1)

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