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临床试验/NCT04514003
NCT04514003进行中(未招募)不适用

The Corona and COVID-19 Study in Telemark and Agder - COVITA

Sykehuset Telemark1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,200
试验地点
1
主要终点
Risk factors for COVID-19

研究概览

简要总结

Through SARS-CoV-2 IgG testing of PCR positive and negative cases the study will follow the COVID-19 immune response by monitoring the SARS-CoV-2 IgG antibody levels over a period of two years. Further, risk factors will be identified by the use of the test-negative design including population controls, allowing comparison of participants with positive and negative tests, and with population controls (triangulation). Special emphasis will be on high risk groups in general and on different occupational, environmental and socio-economic groups in particular. Finally, severity of illness, deaths and the use of health care during will be assessed using national register data from Telemark and Agder.

详细描述

Objectives

The main objectives are:

  1. Monitor the incidence of COVID-19 and the development of the SARS-CoV-2-IgG levels of cases in Agder and Telemark over a period of two years (WP1).
  2. Identify risk factors for COVID-19 by comparison of SARS-CoV-2 antibody positive and negative cases in Telemark and Agder, and comparison of these groups separately with population controls (WP2).
  3. The incidence of neurocognitive symptoms and fatigue in COVID-19 patients (WP3).
  4. Investigation of severity, death and the use of health care for the COVID-19 patients based on data from national registers (WP4).

The main exposures are (WP1-3):

  • Infection (mild, severe) with COVID-19.
  • Occupational risk factors assessed by occupational codes (ISCO88) and job exposure matrix categorisation.
  • Environmental risk factors (road traffic outside bedroom window, travel by foot or bicycle alongside busy roads, and the use of a fireplaces in residential homes. Further, estimated measurements of air pollution may be linked to participants' home address.
  • Socioeconomic status; age, sex, comorbidity, medication use, lifestyle factors (smoking, BMI, physical activity, others), geographic region/municipality, education and income.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 - 85 years
  • •Performed SARS-CoV-2 PCR test

排除标准

  • •Non-Norwegian speakers.
  • •inability to answer questionnaire due to dementia or similar conditions

结局指标

主要结局

Risk factors for COVID-19

时间窗: 2020-2026

Different risk factors (age, sex, education, comorbidity, occupational and environmental exposure will be assessed

SARS-CoV-2 IgG antibody level

时间窗: 2020-2023

Serum Levels of SARS-CoV-2 IgG antibody and the Development of these over a two years period

次要结局

未报告次要终点

研究者

发起方
Sykehuset Telemark
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anne Kristin M. Fell

Associate Professor, senior physician

Sykehuset Telemark

研究点 (1)

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