The Corona and COVID-19 Study in Telemark and Agder

Covid19 Clinical Trial

— COVITA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04514003
• Other study ID #: COVITA
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2035

Study information

• Verified date: November 2023
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
Norway	Telemark Hospital	Skien	Vestfold And Telemark

Sponsors (6)

Lead Sponsor	Collaborator
Sykehuset Telemark	Aalborg University, Leiden University, London School of Hygiene and Tropical Medicine, Norwegian Institute of Public Health, Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Risk factors for COVID-19	Different risk factors (age, sex, education, comorbidity, occupational and environmental exposure will be assessed	2020-2026