Compassionate use of tocilizumab in severe SARS-CoV2 pneumonia

  1. Miguel Górgolas Hernández-Mora
  2. Alfonso Cabello Úbeda
  3. Laura Prieto-Pérez
  4. Felipe Villar Álvarez
  5. Beatriz Álvarez Álvarez
  6. María Jesús Rodríguez Nieto
  7. Irene Carrillo Acosta
  8. Itziar Fernández Ormaechea
  9. Aws Waleed Mohammed Al-Hayani
  10. Pilar Carballosa
  11. Silvia Calpena Martínez
  12. Farah Ezzine
  13. Marina Castellanos González
  14. Alba Naya
  15. Marta López De Las Heras
  16. Marcel José Rodríguez Guzmán
  17. Ana Cordero Guijarro
  18. Antonio Broncano Lavado
  19. Alicia Macías Valcayo
  20. Marta Martín García
  21. Javier Bécares Martínez
  22. Ricardo Fernández Roblas
  23. Miguel Ángel Piris Pinilla
  24. José Fortes Alen
  25. Olga Sánchez Pernaute
  26. Fredeswinda Romero Bueno
  27. Sarah Heili-Frades
  28. Germán Peces-Barba Romero

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Abstract

No abstract available

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  1. Version published to 10.1016/j.ijid.2020.10.045
  2. ScreenIT

    SciScore for 10.1101/2020.06.13.20130088: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Program oversight: All patients signed an informed consent for the compassionate use of tocilizumab before its administration.
    IRB: This study was approved by the Medical Ethics Committee of the Fundación Jiménez Díaz University Hospital.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Analysis were done with SPSS software version 24.0.
    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:
    Our study has several limitations, basically due to the retrospective collection of data and the absence of a control group. Firstly, the decision to administer tocilizumab was made by the medical team responsible for each patient. Therefore, the clinical status of patients and the timing of drug administration after the onset of Covid-19 symptoms were variable; initially it was indicated in very respiratory compromised patients and later it was prescribed much earlier, with lower FiO2 support, letting us study its efficacy in this situation. Secondly, the total amount of drug and number of doses that patients received were not uniform, due, as previously mentioned, to a shortage of the drug in the country during the peak of the epidemic. Thirdly, most patients had received previous and/or concomitant drugs, including systemic corticosteroids and hydroxychloroquine/chloroquine which have anti-inflammatory properties. Therefore, we could not properly assess the impact of these drugs on the overall response of patients treated with tocilizumab. Finally, survival rates would also have been influenced by the UCI committee decision whether a patient was eligible for intubation or not. Only large randomized clinical trials will be able to determine the impact of different immunomodulatory or anti-inflammatory drugs administered simultaneously. In summary, we present the largest series to date on the compassionate use of tocilizumab in severe SARS-Cov-2 pneumonia, and our data shows...

    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 10.1101/2020.06.13.20130088v1 on medRxiv