Systemic Corticosteroids and Mortality in Severe and Critical COVID-19 Patients in Wuhan, China

  1. Jianfeng Wu
  2. Jianqiang Huang
  3. Guochao Zhu
  4. Yihao Liu
  5. Han Xiao
  6. Qian Zhou
  7. Xiang Si
  8. Hui Yi
  9. Cuiping Wang
  10. Daya Yang
  11. Shuling Chen
  12. Xin Liu
  13. Zelong Liu
  14. Qiongya Wang
  15. Qingquan Lv
  16. Ying Huang
  17. Yang Yu
  18. Xiangdong Guan
  19. Yanbing Li
  20. Krishnarajah Nirantharakumar
  21. KarKeung Cheng
  22. Sui Peng
  23. Haipeng Xiao

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Abstract

Background

Systemic corticosteroids are now recommended in many treatment guidelines, although supporting evidence is limited to 1 randomized controlled clinical trial (RECOVERY).

Objective

To identify whether corticosteroids were beneficial to COVID-19 patients.

Methods

A total of 1514 severe and 249 critical hospitalized COVID-19 patients from 2 medical centers in Wuhan, China. Multivariable Cox models, Cox model with time-varying exposure and propensity score analysis (inverse-probability-of-treatment-weighting [IPTW] and propensity score matching [PSM]) were used to estimate the association of corticosteroid use with risk of in-hospital mortality in severe and critical cases.

Results

Corticosteroids were administered in 531 (35.1%) severe and 159 (63.9%) critical patients. Compared to the non-corticosteroid group, systemic corticosteroid use was not associated with beneficial effect in reducing in-hospital mortality in either severe cases (HR = 1.77; 95% CI, 1.08-2.89; P = 0.023), or critical cases (HR = 2.07; 95% CI, 1.08–3.98; P = 0.028). Findings were similar in time-varying Cox analysis. For patients with severe COVID-19 at admission, corticosteroid use was not associated with improved or harmful outcome in either PSM or IPTW analysis. For critical COVID-19 patients at admission, results were consistent with multivariable Cox model analysis.

Conclusion

Corticosteroid use was not associated with beneficial effect in reducing in-hospital mortality for severe or critical cases in Wuhan. Absence of the beneficial effect in our study in contrast to that observed in the RECOVERY clinical trial may be due to biases in observational data, in particular prescription by indication bias, differences in clinical characteristics of patients, choice of corticosteroid used, timing of initiation of treatment, and duration of treatment.

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  1. Version published to 10.1210/clinem/dgaa627
  2. ScreenIT

    SciScore for 10.1101/2020.05.11.20097709: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This study was approved by the ethics committees of Wuhan Hankou Hospital, No. Six Hospital of Wuhan and the First Affiliated Hospital of Sun Yat-sen University, and the informed consent was waived.
    Consent: This study was approved by the ethics committees of Wuhan Hankou Hospital, No. Six Hospital of Wuhan and the First Affiliated Hospital of Sun Yat-sen University, and the informed consent was waived.
    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:
    The major limitation of this study is retrospective nature. Although it was a large scale and the baseline characteristics were balanced between two groups after performing propensity score analysis and time-dependent analysis, our finds should be further validated in randomised controlled trial. In summary, this large observational study shows that there is no evidence of clinical benefit for the use of corticosteroids in severe and critical COVID-19 patients. We do not recommend its routine use outside a trial setting.

    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 10.1101/2020.05.11.20097709 on medRxiv