Trial document





This trial has been registered retrospectively.
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  DRKS00022455

Trial Description

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Title

Prospective SARS-CoV-2 seroprevalence study of schoolchildren after the lockdown March 2020 (COVID-19)

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Trial Acronym

SchoolCoviDD19

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URL of the Trial

[---]*

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Brief Summary in Lay Language

School closures were part of the SARS-CoV-2 pandemic control meassures Germany in March 2020. The effectiveness of this measure depends on the role schoolchildren Play in the transmission of the virus. We aim to understand this role better by conduction repeated seroprevalence studies in schoolchildren and teachers.

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Brief Summary in Scientific Language

School closures are part of the SARS-CoV-2 pandemic control measures in many countries, based on the assumption that children play a similar role in transmitting SARS-CoV-2 as they do in transmitting influenza. We therefore performed a SARS-CoV-2 seropraevalence-study in students and teachers to assess their role in the SARS-CoV-2 transmission.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00022455
  •   2020/07/23
  •   [---]*
  •   yes
  •   Approved
  •   BO-EK-156042020, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 COVID-19
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Interventions/Observational Groups

  •   After the reopening of the schools in Saxony on May 18th, 2020 students grade 8–11 and their teachers in 13 secondary schools in eastern Saxony were invited to participate in the SchoolCoviDD19 study. After teachers, students, and their legal guardians provided informed consent, 5 mL of peripheral venous blood were collected from each individual during visits at each participating school between May 25th and June 30th, 2020. In addition, participants were asked to complete a questionnaire on age, household size, previously diagnosed SARS-CoV-2 infections in themselves or their household contacts, comorbidities and regular medication. In addition, students were asked Manuscript about regular social contacts outside their household or classroom.
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Characteristics

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

- SARS-CoV-2 Seroprevalence immediately after School Reopening in Saxony in May 2020
- SARS-CoV-2 Seroprevalence 6-10 weeks and 4-6 months after School reopening

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/05/18
  •   600
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

students grade 8-11 and teacher at public Schools in Dresden and Bautzen (Saxony, Germany)

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.  Jakob  Armann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.  Jakob  Armann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.  Jakob  Armann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Carl Gustav Carus
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.