Prevalence and determinants of persistent symptoms after infection with SARS-CoV-2: protocol for an observational cohort study (LongCOVID-study)

  1. Elizabeth N Mutubuki
  2. Tessa van der Maaden
  3. Ka Yin Leung
  4. Albert Wong
  5. Anna D Tulen
  6. Siméon de Bruijn
  7. Lotte Haverman
  8. Hans Knoop
  9. Eelco Franz
  10. Albert Jan van Hoek
  11. Cees C van den Wijngaard

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Abstract

A substantial proportion of individuals infected with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), report persisting symptoms weeks and months following acute infection. Estimates on prevalence vary due to differences in study designs, populations, heterogeneity of symptoms and the way symptoms are measured. Common symptoms include fatigue, cognitive impairment and dyspnoea. However, knowledge regarding the nature and risk factors for developing persisting symptoms is still limited. Hence, in this study, we aim to determine the prevalence, severity, risk factors and impact on quality of life of persisting symptoms in the first year following acute SARS-CoV-2 infection.

Methods and analysis

The LongCOVID-study is both a prospective and retrospective cohort study being conducted in the Netherlands, with a one year follow-up. Participants aged 5 years and above, with self-reported positive or negative tests for SARS-CoV-2 will be included in the study. The primary outcome is the prevalence and severity of persistent symptoms in participants that tested positive for SARS-CoV-2 compared with controls. Symptom severity will be assessed for fatigue (Checklist Individual Strength (CIS subscale fatigue severity)), pain (Rand-36/SF-36 subscale bodily pain), dyspnoea (Medical Research Council (mMRC)) and cognitive impairment (Cognitive Failure Questionnaire (CFQ)). Secondary outcomes include effect of vaccination prior to infection on persistent symptoms, loss of health-related quality of life (HRQoL) and risk factors for persisting symptoms following infection with SARS-CoV-2.

Ethics and dissemination

The Utrecht Medical Ethics Committee (METC) declared in February 2021 that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study (METC protocol number 21-124/C). Informed consent is required prior to participation in the study. Results of this study will be submitted for publication in a peer-reviewed journal.

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  1. Version published to 10.1136/bmjopen-2022-062439
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    SciScore for 10.1101/2022.01.10.22269009: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study is carried out by the Dutch National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands. The Utrecht Medical Ethics Committee (METC) declared in February 2021 that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study (METC protocol number 21-124/C).
    Sex as a biological variablenot detected.
    RandomizationA second group of controls, population controls, consists of randomly selected participants from the Basic Registration of Persons (BRP) without a positive test for SARS-CoV-2 infection or known history of probable infections.
    Blindingnot detected.
    Power Analysisnot 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:
    A limitation of this study is that severity scores of only four of symptoms associated with COVID-19 will be calculated to get more insight into clinical significance. This is because only four standardized questionnaires for symptom severity were included in the study. Hence the severity of other possible symptoms related to COVID-19 will not be taken into account. In conclusion, the LongCOVID-study is expected to provide additional insights into the prevalence and severity of persistent symptoms after SARS CoV-2 infection to the international body of literature. In the Netherlands this is the first large scale study on persisting symptoms following SARS CoV2 infection.

    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.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2022.01.10.22269009v1 on medRxiv