Multicenter point-prevalence evaluation of the utilization and safety of drug therapies for COVID-19
Abstract Background There are currently no FDA-approved medications for the treatment of 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 non-interventional, 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 from 15 US hospitals were included. 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 included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 inhibitors (9%). Five patients (7.5%) were receiving combination therapy. Patients with a history of asthma (14.9% vs. 7%, p = 0.037) and those enrolled in clinical trials (26.9% vs.3.2%, p< 0.001) were more likely to receive therapy. Among those receiving COVID-19 therapy, eight patients (12%) experienced an ADR, and ADRs were more commonly recognized in patients enrolled in clinical trials (62.5% vs 22%, OR = 5.9, p = 0.028).Conclusions 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 in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 therapies..
Medienart: |
Preprint |
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Erscheinungsjahr: |
2021 |
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Erschienen: |
2021 |
Enthalten in: |
bioRxiv.org - (2021) vom: 03. Jan. Zur Gesamtaufnahme - year:2021 |
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Sprache: |
Englisch |
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Beteiligte Personen: |
Rhodes, Nathaniel J. [VerfasserIn] |
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Links: |
Volltext [kostenfrei] |
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doi: |
10.1101/2020.06.03.20121558 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
XBI018075940 |
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520 | |a Abstract Background There are currently no FDA-approved medications for the treatment of 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 non-interventional, 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 from 15 US hospitals were included. 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 included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 inhibitors (9%). Five patients (7.5%) were receiving combination therapy. Patients with a history of asthma (14.9% vs. 7%, p = 0.037) and those enrolled in clinical trials (26.9% vs.3.2%, p< 0.001) were more likely to receive therapy. Among those receiving COVID-19 therapy, eight patients (12%) experienced an ADR, and ADRs were more commonly recognized in patients enrolled in clinical trials (62.5% vs 22%, OR = 5.9, p = 0.028).Conclusions 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 in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 therapies. | ||
700 | 1 | |a Dairem, Atheer |e verfasserin |4 aut | |
700 | 1 | |a Moore, William J. |e verfasserin |4 aut | |
700 | 1 | |a Shah, Anooj |e verfasserin |4 aut | |
700 | 1 | |a Postelnick, Michael J. |e verfasserin |4 aut | |
700 | 1 | |a Badowski, Melissa E. |e verfasserin |4 aut | |
700 | 1 | |a Michienzi, Sarah M. |e verfasserin |4 aut | |
700 | 1 | |a Borkowski, Jaime L. |e verfasserin |4 aut | |
700 | 1 | |a Polisetty, Radhika S. |e verfasserin |4 aut | |
700 | 1 | |a Fong, Karen |e verfasserin |4 aut | |
700 | 1 | |a Spivak, Emily S. |e verfasserin |4 aut | |
700 | 1 | |a Beardsley, James R. |e verfasserin |4 aut | |
700 | 1 | |a Hale, Cory M. |e verfasserin |4 aut | |
700 | 1 | |a Pallotta, Andrea M. |e verfasserin |4 aut | |
700 | 1 | |a Srinivas, Pavithra |e verfasserin |4 aut | |
700 | 1 | |a Schulz, Lucas T. |e verfasserin |4 aut | |
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