The Corona and COVID-19 Study in Telemark and Agder

NCT ID: NCT04514003

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2035-12-31

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:

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.

Conditions

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Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SARS-CoV-2 PCR positive cases

Antibody tests will be performed every 6 months for 2 years

No interventions assigned to this group

SARS-CoV-2 PCR negative cases

Antibody tests will be performed at baseline

No interventions assigned to this group

Population controls

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.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Leiden University

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anne Kristin M. Fell

Associate Professor, senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Kristin M. Fell, PhD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Telemark

Locations

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Telemark Hospital

Skien, Vestfold and Telemark, Norway

Site Status

Countries

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Norway

References

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Sarjomaa M, Berg KK, Jaioun K, Tveten Y, Kersten H, Reiso H, Eikeland R, Thilesen C, Nordbo SA, Aaberge IS, Pearce N, Fell AKM. SARS-CoV-2-specific humoral immunity in a Norwegian cohort between 2020 and 2023. BMC Med. 2025 Jun 3;23(1):332. doi: 10.1186/s12916-025-04171-2.

Reference Type DERIVED
PMID: 40462062 (View on PubMed)

Other Identifiers

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COVITA

Identifier Type: -

Identifier Source: org_study_id