Protocol for longitudinal assessment of SARS-CoV-2-specific immune responses in healthcare professionals in Hannover, Germany: the prospective, longitudinal, observational COVID-19 Contact (CoCo) study

  1. Alexandra Jablonka
  2. Christine Happle
  3. Anne Cossmann
  4. Metodi V. Stankov
  5. Anna Zychlinsky Scharff
  6. Diana Ernst
  7. Georg M.N. Behrens

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Abstract

Background

During the current pandemic, healthcare professionals (HCP) have been at the frontline of the crisis. Serological screening may help in identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prevalence. However, given the rapidly evolving situation in spring 2020, many questions regarding coronavirus disease 2019 (COVID-19) infection risk and utility of serological testing remained unanswered. To address these questions, we initiated the COVID-19 Contact (CoCo) study at Hannover Medical School, a large university hospital in Northern Germany and affiliated care providers.

Methods

The CoCo study is an ongoing, prospective, longitudinal, observational study in HCP and individuals with potential contact to SARS-CoV-2. It monitors anti-SARS-CoV-2 immunoglobulin serum levels and collects information on symptoms of respiratory infection, work and home environment, and self-perceived SARS-CoV-2 infection risk. Inclusion criteria are (1) working as HCP in clinical care at our university centre, affiliated hospitals or private practices, (2) written informed consent and (3) age >18 years. Exclusion criteria are (1) refusal to give informed consent and (2) contraindication to venepuncture. Study participants are asked to provide weekly to six-monthly samples (7.5 ml serum and 7.5 ml EDTA blood) and fill out a questionnaire. Since March 2020, around 1250 HCP have been included in the study. At each study visit, sera are screened for anti-SARS-CoV-2 spike protein 1 (S1) immunoglobulin G (IgG) by enzyme-linked immunosorbent assay (ELISA). Positive or borderline positive samples are re-assessed with an alternative serological test. Individual results for each study participant are made available online via a dedicated study website. This study also aims to compare different serological testing assays, as well as explore further humoral and cellular immune markers. Study protocols are continually adapted to the rapidly evolving situation of the current pandemic.

Discussion

This ongoing prospective study will aim to answer central questions on the prevalence and kinetics of anti-SARS-CoV-2-humoral immune responses and the validity of serological testing of HCP in a region with high healthcare standard and comparatively low COVID-19 prevalence. As such, our results are highly relevant to other regions and may support HCP around the world in managing this unprecedented situation.

Trial registration

German Clinical Trial Registry, DRKS00021152. Registered 4th April 2020 -retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021152

Protocol summary

Article activity feed

  1. ScreenIT

    SciScore for 10.1101/2020.12.02.20242479: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Inclusion criteria are (1) working as HCP with direct patient contact in selected departments of Hannover Medical School, affiliated hospitals and private practices, (2) written informed consent, (3) age >18 years.
    IRB: Ethical approval from the Institutional Review Board of Hannover Medical School and data security management approval has been secured (approval # 8973_BO_K_2020).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    In this pilot cohort, an initial prevalence of SARS-CoV-2 IgG antibodies of 0.92% was observed (April 2020).
    SARS-CoV-2 IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Aims: In March 2020, we initiated the CoCo study at Hannover Medical School, a large university hospital in Northern Germany, to address central questions regarding the risk of COVID-19 in HCP and the utility of serological screenings for SARS-CoV-2 in HCP.
    CoCo
    suggested: (CoCo, RRID:SCR_010947)
    Study size calculation and statistical analysis: Descriptive statistics are calculated employing SPSS® Statistics (Version 26) and GraphPad Prism® (Version 5) and presented as mean +SEM or median/range.
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2020.12.02.20242479v1 on medRxiv