Protocol of a population-based prospective COVID-19 cohort study Munich, Germany (KoCo19)

  1. Katja Radon
  2. Elmar Saathoff
  3. Michael Pritsch
  4. Jessica Michelle Guggenbühl Noller
  5. Inge Kroidl
  6. Laura Olbrich
  7. Verena Thiel
  8. Max Diefenbach
  9. Friedrich Riess
  10. Felix Forster
  11. Fabian Theis
  12. Andreas Wieser
  13. Michael Hoelscher
  14. the KoCo19 collaboration group
  15. Abhishek Bakuli
  16. Judith Eckstein
  17. Günter Froeschl
  18. Otto Geisenberger
  19. Christof Geldmacher
  20. Arlett Heiber
  21. Larissa Hoffmann
  22. Kristina Huber
  23. Dafni Metaxa
  24. Michel Pletschette
  25. Camilla Rothe
  26. Mirjam Schunk
  27. Claudia Wallrauch
  28. Thorbjörn Zimmer
  29. Stephan Prückner
  30. Christiane Fuchs
  31. Jan Hasenauer
  32. Noemi Castelletti
  33. Eleftheria Zeggini
  34. Michael Laxy
  35. Reiner Leidl
  36. Lars Schwettmann

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Abstract

Background

Due to the SARS-CoV-2 pandemic, public health interventions have been introduced globally in order to prevent the spread of the virus and avoid the overload of health care systems, especially for the most severely affected patients. Scientific studies to date have focused primarily on describing the clinical course of patients, identifying treatment options and developing vaccines. In Germany, as in many other regions, current tests for SARS-CoV2 are not conducted on a representative basis and in a longitudinal design. Furthermore, knowledge about the immune status of the population is lacking. Nonetheless, these data are needed to understand the dynamics of the pandemic and hence to appropriately design and evaluate interventions. For this purpose, we recently started a prospective population-based cohort in Munich, Germany, with the aim to develop a better understanding of the state and dynamics of the pandemic.

Methods

In 100 out of 755 randomly selected constituencies, 3000 Munich households are identified via random route and offered enrollment into the study. All household members are asked to complete a baseline questionnaire and subjects ≥14 years of age are asked to provide a venous blood sample of ≤3 ml for the determination of SARS-CoV-2 IgG/IgA status. The residual plasma and the blood pellet are preserved for later genetic and molecular biological investigations. For twelve months, each household member is asked to keep a diary of daily symptoms, whereabouts and contacts via WebApp. If symptoms suggestive for COVID-19 are reported, family members, including children < 14 years, are offered a pharyngeal swab taken at the Division of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich, for molecular testing for SARS-CoV-2. In case of severe symptoms, participants will be transferred to a Munich hospital. For one year, the study teams re-visits the households for blood sampling every six weeks.

Discussion

With the planned study we will establish a reliable epidemiological tool to improve the understanding of the spread of SARS-CoV-2 and to better assess the effectiveness of public health measures as well as their socio-economic effects. This will support policy makers in managing the epidemic based on scientific evidence.

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  1. Version published to 10.1186/s12889-020-09164-9
  2. ScreenIT

    SciScore for 10.1101/2020.04.28.20082743: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Inclusion criteria are: Households where the residents are not present at the time of the study team’s visit and do not call back to arrange a baseline visit, do not give informed consent or who do not meet the inclusion criteria will be Non-response is noted and taken into account in the calculation of the response index.
    RandomizationDesign of KoCo19: The study design of KoCo19 is a community-based prospective cohort study in randomly selected Munich households.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study has limitations. In the last years, willingness to participate in population-based studies went down considerably (35, 36). Low response might affect representativeness of the study population, which in turn might have an effect on the generalizability of the prevalence of positive antibody results to the Munich source population. However, it is unlikely that participation will depend on sero-positivity of antibody results as antibody status is unknown prior to inclusion in the study. In addition, the research topic is of uppermost interest for many citizens in the current situation, therefore response is expected to be higher in KoCo19 than in other studies. During the first recruitment days, an overall response of close to 50% was reached providing some evidence for this hypothesis. Response will be increased by revisiting households which did not open the door at the first visit. For the associations under study, representativeness is of less concern (37). However, we might not be able to reach high response especially in specific groups of the target population, e.g. subjects with migration background as they are generally harder to reach in epidemiologic studies (38) and because time constraints do not permit to provide study documents in other languages than German at the initiation of the study. Likewise, the spread of SARS-CoV-2 varies locally and depends on several factors, such as the time course of the infection in the respective region, the population de...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

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  3. Version published to 10.1101/2020.04.28.20082743v1 on medRxiv