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Randomized Controlled Trial
. 2021 Dec;9(4):100581.
doi: 10.1016/j.hjdsi.2021.100581. Epub 2021 Sep 9.

Rapid analysis of local data to inform off-label tocilizumab use early in the COVID-19 pandemic

Affiliations
Randomized Controlled Trial

Rapid analysis of local data to inform off-label tocilizumab use early in the COVID-19 pandemic

Camille E Morgan et al. Healthc (Amst). 2021 Dec.

Abstract

The interleukin-6 receptor antagonist tocilizumab became widely used early in the coronavirus disease 2019 (COVID-19) pandemic based on small observational studies that suggested clinical benefit in COVID-19 patients with a hyperinflammatory state. To inform our local treatment algorithms in the absence of randomized clinical trial results, we performed a rapid analysis of the first 11 hospitalized COVID-19 patients treated with tocilizumab at our academic medical center. We report their early clinical outcomes and describe the process by which we assembled a team of diverse trainees and stakeholders to extract, analyze, and disseminate data during a time of clinical uncertainty.

Keywords: COVID-19; Cytokine release syndrome; Evidence-based decision-making; Interleukin 6 (IL-6); SARS-CoV-2; Tocilizumab.

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Conflict of interest statement

JBP reports research support outside the submitted work from Gilead Sciences, Virology Education, and the World Health Organization, and non-financial support from Abbott Laboratories. CLG has received research support outside the submitted work from Viiv Healthcare and Gilead Sciences. HS is now an employee of ViiV Healthcare. SSC reports research support outside of the submitted work from Biomarck Pharmaceuticals.

Figures

Fig. 1
Fig. 1
Timeline of events. The COVID-19 Rapid Practice Improvement Deployment (RaPID) study of tocilizumab successfully extracted, analyzed, and disseminated its findings to key stakeholders in less than one week.
Fig. 2
Fig. 2
Laboratory and clinical outcome data presented to key stakeholders. (A–B) Laboratory trends in eleven COVID-19 patients after tocilizumab treatment. Medians (blue lines), interquartile ranges (IQR, blue shading), and reference ranges (dashed red lines). (C–D) Oxygen requirements and temperature trends, displayed using locally estimated scatterplot smoothing (orange lines). Patient #6 was treated with two doses of tocilizumab; time 0 refers to the time of initial administration.

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