Sarilumab use in severe SARS-CoV-2 pneumonia

  1. Elisa Gremese
  2. Antonella Cingolani
  3. Silvia Laura Bosello
  4. Stefano Alivernini
  5. Barbara Tolusso
  6. Simone Perniola
  7. Francesco Landi
  8. Maurizio Pompili
  9. Rita Murri
  10. Angelo Santoliquido
  11. Matteo Garcovich
  12. Michela Sali
  13. Gennaro De Pascale
  14. Maurizio Gabrielli
  15. Federico Biscetti
  16. Massimo Montalto
  17. Alberto Tosoni
  18. Giovanni Gambassi
  19. Gian Ludovico Rapaccini
  20. Amerigo Iaconelli
  21. Lorenzo Zileri Del Verme
  22. Luca Petricca
  23. Anna Laura Fedele
  24. Marco Maria Lizzio
  25. Enrica Tamburrini
  26. Gerlando Natalello
  27. Laura Gigante
  28. Dario Bruno
  29. Lucrezia Verardi
  30. Eleonora Taddei
  31. Angelo Calabrese
  32. Francesco Lombardi
  33. Roberto Bernabei
  34. Roberto Cauda
  35. Francesco Franceschi
  36. Raffaele Landolfi
  37. Luca Richeldi
  38. Maurizio Sanguinetti
  39. Massimo Fantoni
  40. Massimo Antonelli
  41. Antonio Gasbarrini

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Abstract

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  1. Version published to 10.1016/j.eclinm.2020.100553
  2. ScreenIT

    SciScore for 10.1101/2020.05.14.20094144: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The shortage of Tocilizumab together with the increasingly number of patients with progressive respiratory symptoms led the multidisciplinary team made of Immuno-rheumatologists, Infectivologists, Pneumologists and Covid-wards clinicians to use Sarilumab, according to a shared clinical-pharmacological protocol (Prot.n.926 approved by the Ethics Comittee of the Fondazione Policlinico Universitario A.
    Consent: Each patient or next of kin provided informed consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis: Statistical analysis was performed using SPSS V.20.0 (SPSS.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    Chicago, Illinois, USA) and Prism software (GrapAHad, San Diego, California, USA).
    Prism
    suggested: (PRISM, RRID:SCR_005375)

    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:
    The limitations of this report are its open-label nature with no comparison group, the limited number of critical-ICU patients and adoption of concomitant treatments of unproven efficacy (possibly increasing the safety results). Moreover, a longer follow-up may be useful to increase the strength of our findings in terms of long-term efficacy and safety of Sarilumab in SARS-CoV-2 severe pneumonia. Yet, an outpatient clinic for these patients has already been set-up to collect prospective clinical and biological informations. In conclusion, IL-6R inhibition is a successful treatment strategy for severe SARS-CoV-2 pneumonia and Sarilumab is a valid and safe alternative in the therapeutic armamentarium of this disease without defined standardized treatment algorythms.

    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 10.1101/2020.05.14.20094144v1 on medRxiv