1. Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States.
- Author
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Rhodes, Nathaniel J, Dairem, Atheer, Moore, William J, Shah, Anooj, Postelnick, Michael J, Badowski, Melissa E, Michienzi, Sarah M, Borkowski, Jaime L, Polisetty, Radhika S, Fong, Karen, Spivak, Emily S, Beardsley, James R, Hale, Cory M, Pallotta, Andrea M, Srinivas, Pavithra, and Schulz, Lucas T
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PREVENTION of drug side effects , *RESEARCH , *HOSPITALS , *INTERLEUKINS , *COVID-19 , *COMBINATION drug therapy , *SCIENTIFIC observation , *ACADEMIC medical centers , *ASTHMA , *HUMAN research subjects , *CROSS-sectional method , *TOCILIZUMAB , *ANTIVIRAL agents , *MEDICAL cooperation , *DESCRIPTIVE statistics , *HYDROXYCHLOROQUINE , *STATISTICAL sampling , *ODDS ratio , *COVID-19 pandemic , *CHEMICAL inhibitors - Abstract
Key points In a multicenter point-prevalence study, we found that the rate of supportive care was high; among those receiving COVID-19 drug therapies, adverse reactions occurred in 12% of patients. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a noninterventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P < 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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