Implementation of SARS-CoV-2 Monoclonal Antibody Infusion Sites at Three Medical Centers in the United States: Strengths and Challenges Assessment to Inform COVID-19 Pandemic and Future Public Health Emergency Use

  1. Anastasia S. Lambrou
  2. John T. Redd
  3. Miles A. Stewart
  4. Kaitlin Rainwater-Lovett
  5. Jonathan K. Thornhill
  6. Lynn Hayes
  7. Gina Smith
  8. George M. Thorp
  9. Christian Tomaszewski
  10. Adolphe Edward
  11. Natalia Elías Calles
  12. Mark Amox
  13. Steven Merta
  14. Tiffany Pfundt
  15. Victoria Callahan
  16. Adam Tewell
  17. Helga Scharf-Bell
  18. Samuel Imbriale
  19. Jeffrey D. Freeman
  20. Michael Anderson
  21. Robert P. Kadlec

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Abstract

Monoclonal antibody therapeutics to treat coronavirus disease (COVID-19) have been authorized by the US Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from 3 sites at medical centers in the United States supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

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  1. Version published to 10.1017/dmp.2022.15
  2. ScreenIT

    SciScore for 10.1101/2021.04.05.21254707: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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 descriptive analysis are rooted in its small sample size of three sites and limited geographic scope. However, this study has been uniquely conducted during the pandemic to inform ongoing public health action and infusion site implementation during this emergency. These therapies are not yet widely available internationally and lessons learned now in the U.S. may be generalizable to other settings implementing monoclonal antibodies for an emerging infectious disease.

    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 10.1101/2021.04.05.21254707v1 on medRxiv