Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities

Article activity feed

1. Version published to 10.1093/infdis/jiab570

   Nov 16, 2021
2. 

   ScreenIT

   Oct 23, 2021

   SciScore for 10.1101/2021.10.19.21265222: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Patient Population and Study Design: After approval by the Mayo Clinic Institutional Review Board, this retrospective study enrolled fully vaccinated patients with breakthrough COVID-19 who were screened for eligibility for treatment with bamlanivimab (Eli Lilly, Indianapolis, IN), bamlanivimab-etesevimab (Eli Lilly, Indianapolis, IN) or casirivimab-imdevimab (Regeneron, New York) as single infusion from January to August 16, 2021.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Data was analyzed using Microsoft Excel (Microsoft Excel for Office 365, Version …

   SciScore for 10.1101/2021.10.19.21265222: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Patient Population and Study Design: After approval by the Mayo Clinic Institutional Review Board, this retrospective study enrolled fully vaccinated patients with breakthrough COVID-19 who were screened for eligibility for treatment with bamlanivimab (Eli Lilly, Indianapolis, IN), bamlanivimab-etesevimab (Eli Lilly, Indianapolis, IN) or casirivimab-imdevimab (Regeneron, New York) as single infusion from January to August 16, 2021.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Data was analyzed using Microsoft Excel (Microsoft Excel for Office 365, Version 16.0.13127.21766, Microsoft Corporation, Redmond, WA) and BlueSky Statistics (Commercial Server Edition, Version 7.40).	Microsoft Excel suggested: (Microsoft Excel, RRID:SCR_016137)

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   This was a retrospective study with the inherent limitations to this study design. For example, we would not have captured treated patients who may have been hospitalized at outside institutions. However, we believe that this is not a considerable number since our program enrolls high-risk patients to a remote monitoring program, thereby ensuring continued contact with these patients until symptom resolution5. Our population was predominantly Caucasian, and our findings may not be generalizable to other patient populations. Most patients received treatment with casirivimab-imdevimab, limiting generalizability to other monoclonal antibodies such as bamlanivimab-etesevimab and sotrovimab. The study observations should also be interpreted in the context that it was performed in patients screened and treated in a single healthcare system. These limitations are counterbalanced by having a relatively large cohort of breakthrough COVID-19 cases identified in our healthcare system, with many identified during the period of the Delta surge. This large patient cohort allowed for robust statistical analysis of the potential efficacy of treatment with monoclonal antibody therapy.

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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.

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

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   Read the original source
3. 

   Version published to 10.1101/2021.10.19.21265222 on medRxiv

   Oct 20, 2021