Protocol of the Luebeck longitudinal investigation of SARS-CoV-2 infection (ELISA) study - a prospective population-based cohort study.


Journal

BMC public health
ISSN: 1471-2458
Titre abrégé: BMC Public Health
Pays: England
ID NLM: 100968562

Informations de publication

Date de publication:
07 07 2022
Historique:
received: 05 04 2022
accepted: 03 06 2022
entrez: 7 7 2022
pubmed: 8 7 2022
medline: 12 7 2022
Statut: epublish

Résumé

Considering the insufficiently controlled spread of new SARS-CoV-2 variants, partially low vaccination rates, and increased risk of a post-COVID syndrome, well-functioning, targeted intervention measures at local and national levels are urgently needed to contain the SARS-CoV-2 pandemic. Surveillance concepts (cross-sectional, cohorts, clusters) need to be carefully selected to monitor and assess incidence and prevalence at the population level. A critical methodological gap for identifying specific risks/dynamics for SARS-Cov-2 transmission and post-COVID-19-syndrome includes repetitive testing for past or present infection of a defined cohort with simultaneous assessment of symptoms, behavior, risk, and protective factors, as well as quality of life. The ELISA-Study is a longitudinal, prospective surveillance study with a cohort approach launched in Luebeck in April 2020. The first part comprised regular PCR testing, antibody measurements, and a recurrent App-based questionnaire for a population-based cohort of 3000 inhabitants of Luebeck. The follow-up study protocol includes self-testing for antibodies and PCR testing for a subset of the participants, focusing on studying immunity after vaccination and/or infection and post-COVID-19 symptoms. The ELISA cohort and our follow-up study protocol will enable us to study the effects of a sharp increase of SARS-CoV-2 infections on seroprevalence of Anti-SARS-CoV-2 antibodies, post-COVID-19-symptoms, and possible medical, occupational, and behavioral risk factors. We will be able to monitor the pandemic continuously and discover potential sequelae of an infection long-term. Further examinations can be readily set up on an ad-hoc basis in the future. Our study protocol can be adapted to other regions and settings and is transferable to other infectious diseases. DRKS.de, German Clinical Trials Register (DRKS), Identifier: DRKS00023418 , Registered on 28 October 2020.

Sections du résumé

BACKGROUND
Considering the insufficiently controlled spread of new SARS-CoV-2 variants, partially low vaccination rates, and increased risk of a post-COVID syndrome, well-functioning, targeted intervention measures at local and national levels are urgently needed to contain the SARS-CoV-2 pandemic. Surveillance concepts (cross-sectional, cohorts, clusters) need to be carefully selected to monitor and assess incidence and prevalence at the population level. A critical methodological gap for identifying specific risks/dynamics for SARS-Cov-2 transmission and post-COVID-19-syndrome includes repetitive testing for past or present infection of a defined cohort with simultaneous assessment of symptoms, behavior, risk, and protective factors, as well as quality of life.
METHODS
The ELISA-Study is a longitudinal, prospective surveillance study with a cohort approach launched in Luebeck in April 2020. The first part comprised regular PCR testing, antibody measurements, and a recurrent App-based questionnaire for a population-based cohort of 3000 inhabitants of Luebeck. The follow-up study protocol includes self-testing for antibodies and PCR testing for a subset of the participants, focusing on studying immunity after vaccination and/or infection and post-COVID-19 symptoms.
DISCUSSION
The ELISA cohort and our follow-up study protocol will enable us to study the effects of a sharp increase of SARS-CoV-2 infections on seroprevalence of Anti-SARS-CoV-2 antibodies, post-COVID-19-symptoms, and possible medical, occupational, and behavioral risk factors. We will be able to monitor the pandemic continuously and discover potential sequelae of an infection long-term. Further examinations can be readily set up on an ad-hoc basis in the future. Our study protocol can be adapted to other regions and settings and is transferable to other infectious diseases.
TRIAL REGISTRATION
DRKS.de, German Clinical Trials Register (DRKS), Identifier: DRKS00023418 , Registered on 28 October 2020.

Identifiants

pubmed: 35799167
doi: 10.1186/s12889-022-13666-z
pii: 10.1186/s12889-022-13666-z
pmc: PMC9261226
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1305

Informations de copyright

© 2022. The Author(s).

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Auteurs

Alexander Balck (A)

Institute of Neurogenetics, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.
Department of Neurology, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.

Bandik Föh (B)

Institute of Nutritional Medicine, University of Lübeck, Lübeck, Germany.
Department of Medicine I, University Hospital Schleswig-Holstein, Lübeck, Germany.

Max Borsche (M)

Institute of Neurogenetics, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.
Department of Neurology, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.

Johann Rahmöller (J)

Institute of Nutritional Medicine, University of Lübeck, Lübeck, Germany.
Department of Anesthesiology and Intensive Care, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.

Eva-Juliane Vollstedt (EJ)

Institute of Neurogenetics, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany.

Frederike Waldeck (F)

Department of Infectious Diseases and Microbiology, University of Lübeck and University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.

Nadja Käding (N)

Department of Infectious Diseases and Microbiology, University of Lübeck and University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.

Christoph Twesten (C)

Perfood GmbH, Lübeck, Germany.

Alexander Mischnik (A)

Health Protection Authority, Lübeck, Germany.

Gabriele Gillessen-Kaesbach (G)

University of Lübeck, Lübeck, Germany.

Marc Ehlers (M)

Institute of Nutritional Medicine, University of Lübeck, Lübeck, Germany.

Christian Sina (C)

Institute of Nutritional Medicine, University of Lübeck, Lübeck, Germany.

Stefan Taube (S)

Institute of Virology and Cell Biology, University of Lübeck, Lübeck, Germany.

Hauke Busch (H)

Lübeck Institute of Experimental Dermatology (LIED), University of Lübeck, Lübeck, Germany.

Jan Rupp (J)

Department of Infectious Diseases and Microbiology, University of Lübeck and University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.

Alexander Katalinic (A)

Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.

Christine Klein (C)

Institute of Neurogenetics, University of Lübeck and University Hospital Schleswig-Holstein, Lübeck, Germany. christine.klein@neuro.uni-luebeck.de.

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