Observational Study of Chlorpromazine in Hospitalized Patients with COVID-19

  1. AP-HP/Universities/INSERM COVID-19 Research Collaboration and AP-HP COVID CDR Initiative
  2. Nicolas Hoertel
  3. Marina Sánchez-Rico
  4. Raphaël Vernet
  5. Anne-Sophie Jannot
  6. Antoine Neuraz
  7. Carlos Blanco
  8. Cédric Lemogne
  9. Guillaume Airagnes
  10. Nicolas Paris
  11. Christel Daniel
  12. Alexandre Gramfort
  13. Guillaume Lemaitre
  14. Mélodie Bernaux
  15. Ali Bellamine
  16. Nathanaël Beeker
  17. Frédéric Limosin

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Abstract

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  1. Version published to 10.1007/s40261-021-01001-0
  2. ScreenIT

    SciScore for 10.1101/2020.07.15.20154310: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This observational non-interventional retrospective study using routinely collected data received approval from the Institutional Review Board of the AP-HP clinical data warehouse (decision CSE-20-20_COVID19, IRB00011591).
    Consent: AP-HP clinical Data Warehouse initiative ensures patients’ information and consent regarding the different approved studies through a transparency portal in accordance with European Regulation on data protection and authorization n°1980120 from National Commission for Information Technology and Civil Liberties (CNIL).
    Randomizationnot detected.
    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:
    Additional limitations of our study include missing data for some variables and potential for inaccuracies in the electronic health records, such as the possible lack of documentation of illnesses or medications, or the misidentification of treatment mode of administration (e.g., dosage, frequency), especially for hand-written medical prescriptions. However, results remained unchanged after using multiple imputation to account for missing data (available on request). Furthermore, patients under chlorpromazine were prescribed a relatively low dosage, i.e., 75 mg per day (SD=4.3), and its antiviral properties might be observable at higher dosages. However, we did not find a significant association between dosage and the primary endpoint. In addition, despite the multicenter design, our results may not be generalizable to other settings or regions. Finally, it is possible that chlorpromazine prescription was motivated mainly by the presence of agitation, which might be a marker of severity of Covid-19. However, the analyses adjusted for current psychiatric disorders, including delirium, and non-psychiatric medical conditions. In this observational study involving patients with Covid-19 who had been admitted to the hospital, chlorpromazine use was not associated with a lower risk of intubation or death. The results suggest that chlorpromazine is unlikely to have a clinical efficacy for Covid-19.

    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.

  3. Version published to 10.1101/2020.07.15.20154310 on medRxiv