Trial document




This trial has been registered retrospectively.
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  DRKS00023418

Trial Description

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Title

ELISA - LübEcker longitudinal study on Infections with SARS-CoV-2 (COVID-19)

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Trial Acronym

ELISA

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URL of the Trial

https://elisa-luebeck.de/

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Brief Summary in Lay Language

The ELISA study aims to provide information on the actual spread of the novel corona virus (SARS-CoV-2) in the population and in risk groups. In particular, it will examine the impact of containment measures and their relaxation on the further spread of SARS-CoV-2. For this purpose, prospective study participants were asked to register pseudonymously as study participants in the study app with the help of a smartphone app and to fill out an initial questionnaire. From these app participants, 3000 people were selected (1500 representative of the Lübeck population in terms of age and gender, 1500 from risk groups with frequent contact to other people). They were examined on five dates (May, June, July, August, September 2020) and will be examined on two further dates (November 2020, February 2021) for active and survived infection with SARS-CoV-2 (nasopharyngeal swab and blood test). In addition, participants will be interviewed every three days via the study app, among other things about signs of illness. This is also intended to identify signs of COVID-19 disease at an early stage in order to better detect COVID-19 disease at an early stage in the future and to allow a well-considered planned detection diagnosis.

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Brief Summary in Scientific Language

Most studies on the SARS-CoV-2 pandemic are conducted in "hotspots" or high-risk regions as cross-sectional studies. It is not known what the spread of SARS-CoV-2 in low-prevalence areas looks like and what the longitudinal development is in a defined cohort. The prospective ELISA cohort study is intended here to provide information on the actual spread of the SARS-CoV-2 virus in the population and in risk groups (persons with many contacts). In particular, it will investigate the impact of containment measures and their relaxation on the spread of SARS-CoV-2. For this purpose, prospective study participants were asked to register pseudonymously as potential study participants in the study app with the help of a smartphone app and to fill in an initial questionnaire. Based on the information provided, a test cohort was selected from these app participants (1500 persons representative of the Lübeck population in terms of age and gender, 1500 persons from risk groups). These 3,000 persons were examined on five dates (May, June, July, August, September 2020) for an active (PCR from nasopharyngeal swab) and a survived SARS-CoV-2 infection (antibody test) and were asked to complete a questionnaire every three days, which contained information on symptoms, contacts with persons with COVID-19, behaviour, children, school and day-care centre, work, leisure time and mobility. Two further test dates (November 2020 and February 2021) will follow. The data collected will also be used to identify symptom signatures that could be used in future to better identify prodromal stages in order to enable rational detection diagnostics.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Data on request,
Data will be made available to the "National Research Network of University Medicine on Covid-19" (B-FAST)

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Organizational Data

  •   DRKS00023418
  •   2020/10/28
  •   [---]*
  •   yes
  •   Approved
  •   20-150, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   COVID-19
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Interventions/Observational Groups

  •   Population cohort and risk cohort (people with a lot of contact with other people) with repetitive interviewing and testing of
    Nasopharyngeal swab PCR and virus sequencing
    Serum antibody tests (IgM-, IgA-, IgG- (in case of a positive IgG result IgG1-, IgG2-, IgG3-, IgG4)-ELISA with the S1 antigen and standardised positive control).
    With certain test persons:
    Odour test with Brief Smell Identification (BSIT) test, serum and urine metabolite tests, urine analyses for SARS CoV-2 specific sequences, whole blood PBMC analyses
    Survey includes questions on health status, possible COVID-19 symptoms and behaviour (e.g. occupation, number of contacts, travel)
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

What is the prevalence of COVID-19 (current and past infections) and SARS-CoV-2 infection rates in a defined population-based population in Lübeck and how many new infections occur in the course of time? (repetitive PCRs and antibody tests)

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Secondary Outcome

What are the COVID-19 prevalence and SARS-CoV-2 infection rates in defined Risk groups and how many new infections occur in the course of the disease?
How does COVID-19 progress and how many SARS-CoV-2 infections remain "asymptomatic"?
How do SARS-CoV-2 detection, antibody profiles, adaptive cellular immune response and COVID-19 diseases; what conclusions can be drawn for draw the longevity of an immunity?
Is it possible to detect the virus in urine?
Can metabolites be identified that are related to the clinical course (e.g. severity of disease, duration of antibody occurrence) correlate?
Can COVID-19 symptoms be distinguished from those of other influenza infections?
Like Do olfactory and gustatory senses behave in the presence of SARS-CoV-2 detection?
Are there any indications of long-term effects of the disease?
Can parameters be identified in the computer model that influence the (regional) Explain the spread/the risk?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/05/06
  •   3000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

persons of full age,
informed consent has been obtained

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Exclusion Criteria

Underage person and persons who are unable to give their consent are not included in the study.

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Addresses

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    • Universität zu Lübeck und Universitätsklinikum Schleswig-Holstein, Campus LübeckKlinik für Neurologie, Institut für Neurogenetik
    • Ms.  Prof. Dr.  Christine  Klein 
    • Maria-Goeppert-Str. 1
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck und Universitätsklinikum Schleswig-Holstein, Campus LübeckKlinik für Neurologie, Institut für Neurogenetik
    • Ms.  Prof. Dr.  Christine  Klein 
    • Maria-Goeppert-Str. 1
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie
    • Mr.  Prof. Dr.  Alexander  Katalinic 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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    • Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2021/03/31
  •   3051
  •   3051
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.