Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04514003

The Corona and COVID-19 Study in Telemark and Agder

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Telemark Hospital

Skien, Vestfold and Telemark, 3710, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Risk factors for COVID-19

    Time frame: 2020-2026

    Different risk factors (age, sex, education, comorbidity, occupational and environmental exposure will be assessed

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Collaborators

  • Aalborg University
  • Leiden University
  • London School of Hygiene and Tropical Medicine
  • Norwegian Institute of Public Health
  • Sorlandet Hospital HF

Registry information

Official study title

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

Acronym: COVITA

Important dates

Study start
2020
Primary completion
2026
Study completion
2035
First posted
Aug 14, 2020
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.