Trial document





This trial has been registered retrospectively.
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  DRKS00024860

Trial Description

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Title

Longitudinal SARS-CoV-2-infection study with medical and dental students at Ulm University

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Trial Acronym

COVID-19 MedStud Ulm

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study aims to investigate the infection situation with the novel coronavirus among medical and dental students in Ulm, Germany, during the winter semester (November 2020 to March 2021). In addition to the protection aspect for students and teaching staff, we want to gain important new insights into the feasibility of face-to-face teaching under pandemic conditions. We are offering students from the first to the sixth semester to participate in the study. Teaching staff have also been invited. Everyone is tested for antibody status to SARS-CoV-2 at the beginning and end of the semester. This test provides a "window into the past", since antibodies are usually detectable months after infection, even in silent, so-called asymptomatic infections. Both antibody tests are accompanied by a questionnaire that provides us with information about health status, living circumstances, COVID-19 symptoms or past SARS-CoV-2 infections, and also captures concerns about studying. In fall of 2020, young people were considered to be "drivers" of the second wave in Germany because they often have social contacts and are more likely to have mild or even silent infections. We wanted to examine this possible relationship and likewise find out if we could use comprehensive hygiene concepts and repeated teaching of compliance with infection control and hygiene measures to conduct face-to-face courses that are considered essential in medical school (in this case, the macroscopic anatomy course in particular). By repeatedly measuring antibody levels in the blood at the end of the semester, we also hope to find out how immunity develops in a young group of people over the course of approximately three months. In the groups with more teaching in presence, we additionally offered throat swabs with direct pathogen detection in the laboratory to also find out something about the acute infection situation, i.e. to identify silent infected people in particular. We think that this study will provide important insights into the infection situation in young adults during the second wave of the pandemic and also whether and how teaching in presence can be conducted at universities.

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Brief Summary in Scientific Language

In this study, several semester cohorts of medical and dental students as well as the teaching staff of the Institute of Anatomy and Cell Biology will be invited to participate.
Each will be offered an antibody test at the beginning and end of the semester (quantitative, antibodies against spike protein, IgG, IgM and IgA, Roche Elecsys Anti-SARS-CoV-2 S). Accompanying each test we give out a questionnaire that provides information about health status, symptoms in the past, acute or indirect pathogen detection, living conditions and concerns about their future. Furthermore, especially the cohort attending the macroscopic anatomy course will be offered two times during the semester (start of semester and after New Year) to condutct an acute pathogen detection. Inclusion criteria are only individuals without symptoms suspicious for COVID-19. A naso- and oropharyngeal swab with subsequent laboratory PCR analysis will be performed (Roche Cobas). A rapid test will be offered before the Christmas break and after the end of the semester (Roche SARS-CoV-2 Rapid Antigen Test).

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

Yes

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Description IPD sharing plan:

We are happy to share the study protocol upon request. Release of anonymized data can be discussed in consultation with the Ethics Committee Ulm.

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Organizational Data

  •   DRKS00024860
  •   2021/04/27
  •   [---]*
  •   yes
  •   Approved
  •   405/20, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Students of the first 3 years of study in human medicine and dentistry
  •   Tutors of the macroscopic anatomy course
  •   Teaching staff of the course of macroscopic anatomy
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Characteristics

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

Determination of infection status (direct pathogen detection, antibodies) with SARS-CoV-2 and accompanying questionnaire at the beginning, during and after the winter semester 20/21

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Secondary Outcome

not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
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Recruitment

  •   Actual
  •   2020/11/05
  •   1102
  •   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

Human and dental students in their first three years of study; largest cohort: students, teaching staff of the macroscopic anatomy course; minimum age 18 years; written informed consent

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Exclusion Criteria

Severe congenital conditions (e.g., infantile cerebral palsy, severe congenital malformations); congenital or acquired immunodeficiencies; current symptoms of COVID-19 disease; other reasons to object to swab or blood collection; lack of consent

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Addresses

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    • Medizinische Fakultät Universität Ulm
    • Albert-Einstein-Allee 7
    • 89081  Ulm
    • Germany
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    • Zentrum für Klinische Studien Ulm Medizinische Fakultät und Universitätsklinik Ulm
    • Ms.  Dr.  Nicole  Lang 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Institut für Anatomie und Zellbiologie Universität Ulm
    • Mr.  Dr. med.  Michael  Schön 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Institut für Anatomie und Zellbiologie Universität Ulm
    • Mr.  Dr. med.  Michael  Schön 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Anatomie und Zellbiologie Universität Ulm
    • Mr.  Prof. Dr. med.  Tobias M.  Böckers 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Sonderfördermaßnahme COVID-19 des Landes Baden-Württemberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2021/03/02
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Trial Publications, Results and other Documents

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