Tocilizumab Effect in COVID-19 Hospitalized Patients: A Systematic Review and Meta-Analysis of Randomized Control Trials

  1. Basheer Abdulrahman
  2. Waleed Th Aletreby
  3. Ahmed F Mady
  4. Alfateh Mohammed Noor
  5. Mohammed Lhmdi
  6. Fahad Faqihi
  7. Abdulrahman M Alharthy
  8. Mohammed A Al-Odat
  9. Dimitrios Karakitsos
  10. Ziad A Memish

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Abstract

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  1. Version published to 10.26502/aimr.0104
  2. ScreenIT

    SciScore for 10.1101/2021.03.15.21253581: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    RandomizationThe Cochrane Collaboration tool assesses RoB in each included study with regards to 7 domains, namely: random sequence generation, allocation concealment, blinding of participants, blinding of assessors, attrition bias, selective reporting bias, in addition to other sources of bias.
    BlindingThe Cochrane Collaboration tool assesses RoB in each included study with regards to 7 domains, namely: random sequence generation, allocation concealment, blinding of participants, blinding of assessors, attrition bias, selective reporting bias, in addition to other sources of bias.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Experimental Models: Organisms/Strains
    SentencesResources
    The final search list was reviewed by three authors (AB, MA, AW) for final inclusion in the review, any disagreements were resolved by discussion.
    AB
    suggested: RRID:BDSC_203)
    Software and Algorithms
    SentencesResources
    Search strategy: We systematically searched for eligible studies in PUBMED, EMBASE, and medical archives (medRxiv) using the keywords: “COVID-19”, “SARS-CoV-2”, and “Tocilizumab” (details of Pubmed search in supplementary file).
    PUBMED
    suggested: (PubMed, RRID:SCR_004846)
    EMBASE
    suggested: (EMBASE, RRID:SCR_001650)
    Risk of bias (RoB) and quality of evidence assessment: Each included study was evaluated independently by 2 authors for RoB using the modified version of the Cochrane Collaboration Tool [13], the tool is built in within the Review Manager ® software.
    Cochrane Collaboration Tool
    suggested: None
    All statistical tests and graphs were generated using STATA 14 software (StataCorp. 2015. Stata Statistical
    STATA
    suggested: (Stata, RRID:SCR_012763)
    StataCorp
    suggested: (Stata, RRID:SCR_012763)
    StataCorp LP) and Review Manager (RevMan)
    RevMan
    suggested: (RevMan, RRID:SCR_003581)

    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:
    These benefits of TCZ particularly on mortality were demonstrated by several observational studies as well as reviews including observational studies [7,10], however, such results are questionable in view of the inherent limitations of observational studies in terms of design, in addition to patients’ severity and clinical condition variations [23], furthermore, other reviews failed to demonstrate such benefits, the review by Lan SH et al [25] concluded no additional benefits of TCZ on mortality, mechanical ventilation, and ICU admission, although these results should also be looked at cautiously, in view of the substantial heterogeneity in all three outcomes, and of course the observational nature of the included studies. What was agreed upon by almost all the early studies and reviews was the need for well-designed randomized clinical trials. In our review the outcome of short term (28 – 30 day) mortality showed no statistical significance of TCZ, however, this result should be meticulously examined, as it only reports statistical significance, while overlooking potential clinical benefit, the RR was found to be 0.9, however, the 95% CI was 0.8 – 1.01, with an overall effect p value of 0.09. While statistically insignificant, we should understand that the significance was only missed by 0.01 in the 95% CI, more importantly, the result should not be interpreted as lack of effect, but rather as not enough evidence to reject the null hypothesis, and consequently, a clinically ...

    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 10.1101/2021.03.15.21253581v1 on medRxiv