Corticosteroid Use in Severely Hypoxemic COVID-19 Patients: An Observational Cohort Analysis of Dosing Patterns and Outcomes in the Early Phase of the Pandemic

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Abstract

INTRODUCTION

Hypoxemia in Severe Acute Respiratory Syndrome due to Novel Coronavirus of 2019 (SARS-CoV-2) is mediated by severe inflammation that may be mitigated by corticosteroids. We evaluated pattern and effects of corticosteroid use in these patients during an early surge of the pandemic.

METHODS

Observational study of 136 SARS-CoV-2 patients admitted to the Intensive care Unit between March 1 and April 27, 2020 at a tertiary care hospital in Indianapolis, USA.

Statistical comparison between cohorts and dosing pattern analysis was done. Outcome measures included number of patients requiring intubation, duration of mechanical ventilation, length of ICU stay and inpatient mortality.

RESULTS

Of 136 patients, 72 (53%) received corticosteroids. Groups demographics: Age (60.5 vs. 65; p .083), sex (47% male vs. 39% female; p .338) and comorbidities were similar. Corticosteroid group had increased severity of illness: PaO2/FiO2 (113 vs. 130; p .014) and SOFA (8 vs. 5.5; p < .001). Overall mortality (21% vs. 30%; p .234) or proportion of patients intubated (78 vs. 64%; p .078) was similar. Mortality was similar among mechanically ventilated (27% vs. 15%; p .151) however there were no deaths among patients who were not mechanically ventilated and received corticosteroids (0% vs. 57%; p <.001). Early administration (within 48 hours) showed decrease in proportion of intubation (66% vs. 87 vs. 100%; p .045), ICU days (6 vs., 16 vs. 18; p <.001), and ventilator days (3 vs. 12 & 14; p <.001). 45% received methylprednisolone.

CONCLUSION

Corticosteroids were used more frequently in SARS CoV-2 patients with higher severity of illness. Early administration of corticosteroids improved survival in non-mechanically ventilated patients; decreased ICU stay and may have prevented intubation.

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  1. SciScore for 10.1101/2020.07.29.20164277: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Study Population: The Indiana University (IU) Institutional Review Board (IRB) approved the conduct of this study and deemed it exempt (IRB study number 2005800938).
    Consent: Informed consent was waived, and de-identified data were analyzed.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis was performed using Microsoft Excel (Version 16.38; Microsoft, 2020).
    Microsoft Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)

    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. SciScore for 10.1101/2020.07.29.20164277: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementCorticosteroids  Author’s contribution: Acquisition, analysis, interpretation of data: OR, RAT, RMK, EMM, MKC, CLT, RK Conception, drafting, and revision of work: OR, RK, MKC, RAT, RML, EMM, SAP Final approval of work: OR, RAT, MKC, RMK, EMM, CLT, SAP, RK MATERIALS AND METHODS Study Population The Indiana University (IU) Institutional Review Board (IRB) approved the conduct of this study and deemed it exempt (IRB study number 2005800938).RandomizationThe ARDS Network’s large randomized trial of methylprednisolone versus placebo in 180 patients with ARDS of at least 7 days duration showed that while there was no survival benefit in the corticosteroid group, methylprednisolone increased the number of ventilator-free days and ICU-free days during the first 30 days [21].Blindingnot detected.Power Analysisnot detected.Sex as a biological variableGroups demographics: Age (60.5 vs. 65; p .083), sex (47% male vs. 39% female; p .338) and comorbidities were similar.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis was performed using Microsoft Excel (Version 16.38; Microsoft, 2020).
    Microsoft Excel
    suggested: (Microsoft Excel, SCR_016137)

    Data from additional tools added to each annotation on a weekly basis.

    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 is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.