Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia

  1. Carlos Salama
  2. Jian Han
  3. Linda Yau
  4. William G. Reiss
  5. Benjamin Kramer
  6. Jeffrey D. Neidhart
  7. Gerard J. Criner
  8. Emma Kaplan-Lewis
  9. Rachel Baden
  10. Lavannya Pandit
  11. Miriam L. Cameron
  12. Julia Garcia-Diaz
  13. Victoria Chávez
  14. Martha Mekebeb-Reuter
  15. Ferdinando Lima de Menezes
  16. Reena Shah
  17. Maria F. González-Lara
  18. Beverly Assman
  19. Jamie Freedman
  20. Shalini V. Mohan

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Abstract

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  1. Version published to 10.1056/nejmoa2030340
  2. ScreenIT

    SciScore for 10.1101/2020.10.21.20210203: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: All patients or their legally authorized representative gave informed consent.
    IRB: Institutional review boards or ethics committees approved the protocol.
    RandomizationTrial Design and Oversight: EMPACTA is a randomized, double-blind, placebo-controlled, phase III study to evaluate the safety and efficacy of tocilizumab in hospitalized, nonventilated patients with Covid-19 pneumonia (ClinicalTrials.gov NCT04372186).
    Blindingnot detected.
    Power AnalysisStatistical Analysis: A modified intent-to-treat (mITT, all randomized patients who received any study medication) population of 379 patients with 2:1 randomization was estimated to provide at least 80% power to detect a 15% difference between groups for the primary objective using a log-rank test assuming cumulative event rate (death or requiring mechanical ventilation) of 25% and 40% in the tocilizumab and placebo groups, respectively.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The sponsor (Genentech, Inc.) designed the study, conducted it per the protocol, collected the data, and performed the analyses.
    Genentech
    suggested: (Genentech, RRID:SCR_003997)

    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: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04372186RecruitingA Study to Evaluate the Efficacy and Safety of Tocilizumab i…

    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 10.1101/2020.10.21.20210203v1 on medRxiv