Covid19COVITANCT04514003
The Corona and COVID-19 Study in Telemark and Agder
An observational study of Covid19, run by Sykehuset Telemark at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 1,200 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jul 2020to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inhabitants of Agder and Telemark County in Norway fulfilling the inclusion criteria.
Who may be able to join
- Age 18 - 85 years
- Performed SARS-CoV-2 PCR test
Who cannot join
- Non-Norwegian speakers.
- Deceased
- inability to answer questionnaire due to dementia or similar conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Corona and COVID-19 Study in Telemark and Agder - COVITA
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.
Read the detailed description
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.
- Conditions
- Covid19
- Keywords
- Immunity, Risk factors, Test-negative design, Population controls
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 IgG antibody level
Serum Levels of SARS-CoV-2 IgG antibody and the Development of these over a two years period
Measured: 2020-2023
Risk factors for COVID-19
Different risk factors (age, sex, education, comorbidity, occupational and environmental exposure will be assessed
Measured: 2020-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Sorlandet Hospital HF, Norwegian Institute of Public Health, London School of Hygiene and Tropical Medicine, Leiden University, Aalborg University
- Responsible party
- Principal investigator, Anne Kristin M. Fell, Sykehuset Telemark
- Investigators
- Anne Kristin M. Fell, PhD, Principal investigator, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514003
- Sponsor's protocol ID
- COVITA
- Acronym
- COVITA
- Status last verified
- Nov 2024
- First submitted
- 13 Aug 2020
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40462062
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Corona and COVID-19 Study in Telemark and Agder - COVITA
- ClinicalTrials.gov ID
- NCT04514003
- Acronym / sponsor ID
- COVITA / COVITA
- Conditions
- Covid19
- Keywords
- Immunity, Risk factors, Test-negative design, Population controls
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Sorlandet Hospital HF, Norwegian Institute of Public Health, London School of Hygiene and Tropical Medicine, Leiden University, Aalborg University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inhabitants of Agder and Telemark County in Norway fulfilling the inclusion criteria.
Key inclusion criteria (2 listed)
- Age 18 - 85 years
- Performed SARS-CoV-2 PCR test
Key exclusion criteria (3 listed)
- Non-Norwegian speakers.
- Deceased
- inability to answer questionnaire due to dementia or similar conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SARS-CoV-2 IgG antibody level
Time frame: 2020-2023
Serum Levels of SARS-CoV-2 IgG antibody and the Development of these over a two years period
Risk factors for COVID-19
Time frame: 2020-2026
Different risk factors (age, sex, education, comorbidity, occupational and environmental exposure will be assessed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 40462062Sarjomaa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Kristin M. Fell, PhD principal investigator
Sykehuset Telemark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 IgG antibody level (time frame: 2020-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.