The Corona and COVID-19 Study in Telemark and Agder

Study Overview
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Brief Summary
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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.

Detailed Description
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Objectives The main objectives are: 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). 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). The incidence of neurocognitive symptoms and fatigue in COVID-19 patients (WP3). 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.

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

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 85 years Performed SARS-CoV-2 PCR test Exclusion Criteria: Non-Norwegian speakers. Deceased inability to answer questionnaire due to dementia or similar conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 PCR positive cases<br>Antibody tests will be performed every 6 months for 2 years | |
| SARS-CoV-2 PCR negative cases<br>Antibody tests will be performed at baseline | |
| Population controls<br>A large sample (n= 22500) from the general population will be included to assess risk factors. No blood sample will be collected for this group and the data needed is already collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 IgG antibody level | Serum Levels of SARS-CoV-2 IgG antibody and the Development of these over a two years period | 2020-2023 | 
| Risk factors for COVID-19 | Different risk factors (age, sex, education, comorbidity, occupational and environmental exposure will be assessed | 2020-2026 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunity, Risk factors, Test-negative design, Population controls