Trial document




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  DRKS00021709

Trial Description

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Title

Serial cross-sectional seroprevalence study of SARS-CoV-2 infection during and after the COVID-19 epidemic in Heidelberg and the Rhein-Neckar region

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Trial Acronym

SARS-CoV-2 seroprevalence study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The objective of this study is to determine the proportion of people in the general population of Heidelberg and the Rhein-Neckar region with antibodies against the coronavirus.

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Brief Summary in Scientific Language

The primary objective of this study is to estimate the age-group specific prevalence of antibodies to SARS-CoV-2 among the general population of Heidelberg and the Rhein-Neckar region. In total 1500 persons from five age-groups will be randomly selected from the population registers. Study participants will be tested for antibodies at three different time points: one study visit will take place during the current epidemic, one post-epidemic and one between these two timepoints. A questionnaire will be administered at each study visit to collect information about symptoms and potential risk factors for SARS-CoV-2 infection.

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

Yes

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Description IPD sharing plan:

Pseudonymized study data may be requested from the study PI for research on coronaviruses or other respiratory viruses. If requested, the data and the study protocol will be made available for download via a password-protected download link of Heidelberg University’s cloud service heiBOX. Study data will be shared after publication of the main study results.

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Organizational Data

  •   DRKS00021709
  •   2020/05/18
  •   [---]*
  •   yes
  •   Approved
  •   S-279/2020, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   SARS-CoV-2 infection
  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Study participants will be asked to come to the clinic three times or alternatively may be visited at home by study personnel. At each visit, a blood sample will be collected and a questionnaire administered to collect information on previous COVID-19 diagnosis, symptoms, drug intake, risk factors and protective measures. The blood sample will be tested for antibodies against SARS-CoV-2. The visits will take place at the following time points: 1) during the current epidemic, 2) 4-6 months after the enrollment visit, 3) >9 months after the enrollment visit.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Screening
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Age-group specific prevalence of antibodies to SARS-CoV-2 among the general population of Heidelberg and the Rhein-Neckar region.

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Secondary Outcome

1) Age-group specific cumulative incidence during the epidemic compared to the end of the epidemic (post-epidemic) or according to local COVID-19 epidemiology.
2) Association of risk factors / protective measures recorded on the questionnaire and evidence of SARS-CoV-2 infection (SARS-CoV-2 antibodies).
3) Proportion of asymptomatic / sub-clinical SARS-CoV-2 infections.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/07/03
  •   1500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

a) Able to provide a blood sample
b) Able to attend the Tropical Medicine clinic for blood draw or be available for a house visit
c) In adults, the ability to provide fully informed consent
d) Consent from a parent or guardian if the patient is under 18

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Exclusion Criteria

a) Contraindication to venepuncture
b) Age below 5 years of age
c) Not able to provide informed consent

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Addresses

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Sources of Monetary or Material Support

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    • SAP
    • 69190  Walldorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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