Real-world clinical outcomes of treatment with casirivimab-imdevimab among patients with mild-to-moderate coronavirus disease 2019 during the Delta variant pandemic

  1. Yasuhito Suzuki
  2. Yoko Shibata
  3. Hiroyuki Minemura
  4. Takefumi Nikaido
  5. Yoshinori Tanino
  6. Atsuro Fukuhara
  7. Ryuzo Kanno
  8. Hiroyuki Saito
  9. Shuzo Suzuki
  10. Taeko Ishii
  11. Yayoi Inokoshi
  12. Eiichiro Sando
  13. Hirofumi Sakuma
  14. Tatsuho Kobayashi
  15. Hiroaki Kume
  16. Masahiro Kamimoto
  17. Hideko Aoki
  18. Akira Takama
  19. Takamichi Kamiyama
  20. Masaru Nakayama
  21. Kiyoshi Saito
  22. Koichi Tanigawa
  23. Masahiko Sato
  24. Toshiyuki Kanbe
  25. Norio Kanzaki
  26. Teruhisa Azuma
  27. Keiji Sakamoto
  28. Yuichi Nakamura
  29. Hiroshi Ohtani
  30. Mitsuru Waragai
  31. Shinsaku Maeda
  32. Tokiya Ishida
  33. Keishi Sugino
  34. Yasuhiko Tsukada
  35. Ryuki Yamada
  36. Riko Sato
  37. Takumi Onuma
  38. Hikaru Tomita
  39. Mikako Saito
  40. Natsumi Watanabe
  41. Mami Rikimaru
  42. Takaya Kawamata
  43. Takashi Umeda
  44. Julia Morimoto
  45. Ryuichi Togawa
  46. Yuki Sato
  47. Junpei Saito
  48. Kenya Kanazawa
  49. Ken Iseki

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Abstract

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  1. Version published to 10.7150/ijms.71132
  2. ScreenIT

    SciScore for 10.1101/2021.12.19.21268078: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Ethics statement: The need for informed consent was waived because the study is retrospective.
    IRB: This study was approved by the Ethics Committee of Fukushima Medical University (approval number 2020-118, approved on August 3, 2020, updated September 01, 2021).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical analyses were performed using JMP 13 (SAS Institute Inc, Cary NC) and EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan).
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)

    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 several limitations to the present study. First, this was an observational and retrospective study, and does not show evidence comparable to a randomized clinical trial. Although we carefully adjusted clinical outcomes for various potential cofounding factors, potential bias due to the study design is inevitable. Second, in some subjects, the precise information about the number of days between COVID-19 symptom onset and the administration of casirivimab-imdevimab, and the day of deterioration were not included in our electronic database. Therefore, there may be some influence on the clinical outcomes. Third, the adverse effects of casirivimab-imdevimab were not evaluated in detail. However, according to previous studies, adverse effects were uncommon and mild [5, 10]. Fourth, information regarding which SARS-CoV-2 variant each individual had was not included in the current study. However, as we mentioned above, almost all patients were considered to be infected with the Delta variant during the study period in most of Japan [3], including Fukushima Prefecture [11]. Fifth, regarding the vaccinated patients information on how many days before disease onset they completed SARS-CoV-2 vaccination was not available. Although the vast majority of healthy individuals respond to the vaccines and obtain full efficacy against SARS-CoV-2 at least 7 days after second vaccination [26], some of our subjects may have been infected with the virus shortly after their second vaccinat...

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.12.19.21268078 on medRxiv