Combination therapy with tocilizumab and corticosteroids for aged patients with severe COVID-19 pneumonia: A single-center retrospective study

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Abstract

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  1. SciScore for 10.1101/2020.09.26.20202283: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The Clinical Research Ethics Committee approved the study protocol and granted a waiver of informed consent due to its observational design.
    Consent: All these drugs were used off-label and oral or written informed consent was previously obtained.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis was performed with SPSS version 22.0 (IBM Corporation®, Armonk, NY).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    There are a number of limitations in our study to be acknowledged. First, due to its retrospective observational design, the impact of unmeasured confounders cannot be completely ruled out, even after PS-based and IPTW adjustments. As discussed above, the direction of potential bias is not obvious in view of the nature of baseline imbalances. Likewise, we have attempted to minimize the risk of survivor bias by excluding those patients dying within the first 24 hours and by means of landmark survival analyses. Second, different regimens of corticosteroids and TCZ were used, preventing us to conclude on optimal dosing strategies. Finally, the single-center design hampers the applicability of findings to other settings. The Infectious Disease Society of America has recently highlighted in their evidence-based guidelines (19) that RCTs constitute the optimal framework to evaluate the efficacy and safety of newer therapies for COVID-19. Indeed, a number of ongoing trials are aimed at comparing TCZ versus corticosteroids (NCT04345445 and NCT04377503), corticosteroids alone or associated to TCZ (NCT04476979), and TCZ versus TCZ plus corticosteroids (NCT04486521). Until the results of these RCTs become available, observational studies might be useful to guide clinical decisions providing that caution is applied before concluding on potential causation. In conclusion, the present experience suggests that the use of IV TCZ on top of corticosteroid therapy may be more useful than cortic...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04345445Not yet recruitingStudy to Evaluate the Efficacy and Safety of Tocilizumab Ver…
    NCT04377503Not yet recruitingTocilizumab Versus Methylprednisolone in the Cytokine Releas…
    NCT04476979RecruitingComparison of Tocilizumab Plus Dexamethasone vs. Dexamethaso…
    NCT04486521RecruitingClinical Outcome of Anti-IL6 vs Anti-IL6 Corticosteroid Comb…


    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.