The Corona and COVID-19 Study in Telemark and Agder

NCT04514003 | Active Not Recruiting DMC

• 1 other identifier: COVITA
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

Immunity; Risk factors; Test-negative design; Population controls

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

SARS-CoV-2 PCR positive cases

Antibody tests will be performed every 6 months for 2 years

SARS-CoV-2 PCR negative cases

Antibody tests will be performed at baseline

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inhabitants of Agder and Telemark County in Norway fulfilling the inclusion criteria.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sykehuset Telemark: lead
• Sorlandet Hospital HF: collaborator
• Norwegian Institute of Public Health: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Leiden University: collaborator
• Aalborg University: collaborator

Study Sites (1)

Telemark Hospital

Skien, Vestfold and Telemark, 3710, Norway

Location

Related Publications (1)

• 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.

  PMID: 40462062 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for SARS-CoV-2 IgG antibody testing

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anne Kristin M. Fell, PhD

  Sykehuset Telemark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, senior physician

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 14, 2020
• Study Start: July 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2035
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)