Corticosteroid treatment has no effect on hospital mortality in COVID-19 patients

  1. Filippo Albani
  2. Federica Fusina
  3. Enza Granato
  4. Cristina Capotosto
  5. Claudia Ceracchi
  6. Riccardo Gargaruti
  7. Giovanni Santangelo
  8. Luca Schiavone
  9. Maria Salvatrice Taranto
  10. Cinzia Tosati
  11. Elena Vavassori
  12. Giuseppe Natalini

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Abstract

Since the start of the novel coronavirus 2019 (COVID-19) pandemic, corticosteroid use has been the subject of debate. The available evidence is uncertain, and knowledge on the subject is evolving. The aim of our cohort study was to evaluate the association between corticosteroid therapy and hospital mortality, in patients hospitalized with COVID-19 after balancing for possible confounders. One thousand four hundred forty four patients were admitted to our hospital with a positive RT-PCR test for SARS-CoV-2, 559 patients (39%) were exposed to corticosteroids during hospital stay, 844 (61%) were not exposed to corticosteroids. In the cohort of patients exposed to corticosteroids, 171 (30.6%) died. In the cohort of patients not exposed to corticosteroids, 183 (21.7%) died (unadjusted p  < 0.001). Nonetheless, exposure to corticosteroids was not associated with in-hospital mortality after balancing with overlap weight propensity score (adjusted p  = 0.25). Patients in the corticosteroids cohort had a reduced risk of ICU admission (adjusted p  < 0.001). Treatment with corticosteroids did not affect hospital mortality in patients with COVID-19 after balancing for confounders. A possible advantage of corticosteroid therapy was to reduce Intensive Care Unit admission, which could be useful in reducing pressure on Intensive Care Units in times of limited resources, as during the COVID-19 pandemic.

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  1. Version published to 10.1038/s41598-020-80654-x
  2. ScreenIT

    SciScore for 10.1101/2020.07.17.20155994: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study protocol was approved by the Ethical Committee of Brescia (NP-4210).
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisOne thousand three hundred seventy seven patients were needed to obtain a power of 85% to detect an Odds Ratio 0.72, assuming mortality was 25% in those receiving corticosteroids, with a fraction of patients treated of 1:3 and alpha=0.058.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis was performed using R Studio software version 4.0.0 (R Core Team, 2014) and packages ‘psw’ and ‘E-value’ for overlap weight propensity score and calculation of E-value.
    R Studio
    suggested: None

    Results from OddPub: Thank you for sharing your code and data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Nevertheless, this study suffered some relevant limitations. Corticosteroids therapy was assessed in a small cohort of ARDS patients (84 patients), and 50 out of them (60%) received methylprednisolone. More relevantly, data were shown without any balancing for possible confounders. The crude mortality in our study was higher in patients treated with corticosteroids than in patients who did not receive them. The risk of in-hospital death did not differ between treated and non treated patients when adjusted for patients’ characteristics, which were similar to the ones described in previous studies.25–27 The lack of effect of steroids on crude mortality has been previously reported in COVID-19 patients.28,29 Recently a pre-print, not peer-reviewed manuscript of a randomized clinical trial (RCT) called RECOVERY trial was made available. This trial reports a 3% reduction of hospital mortality with the use of corticosteroids in COVID-19 patients. We hope that the peer reviewed results and conclusions of this study will be made available as soon as possible, so as to have a better understanding of the effects of corticosteroids in COVID-19.30 Nonetheless data from randomized clinical trials should always be compared to data from observational studies, because it might suffer from limited external validity. In many occasions, randomized trials on septic patients were not subsequently confirmed and their importance was reduced with time, including what concerned the use of steroids.31...

    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 10.1101/2020.07.17.20155994 on medRxiv