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
© American Society of Health-System Pharmacists 2021. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com..
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.
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:78 |
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| Enthalten in: |
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists - 78(2021), 7 vom: 18. März, Seite 568-577 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rhodes, Nathaniel J [VerfasserIn] |
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| Themen: |
4QWG6N8QKH |
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| Anmerkungen: |
Date Completed 31.03.2021 Date Revised 31.03.2024 published: Print UpdateOf: medRxiv. 2020 Jun 05;:. - PMID 32577687 Citation Status MEDLINE |
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| doi: |
10.1093/ajhp/zxaa426 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM320985121 |
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| 100 | 1 | |a Rhodes, Nathaniel J |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 31.03.2021 | ||
| 500 | |a Date Revised 31.03.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a UpdateOf: medRxiv. 2020 Jun 05;:. - PMID 32577687 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © American Society of Health-System Pharmacists 2021. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
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| 650 | 4 | |a adverse drug reaction | |
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| 700 | 1 | |a Postelnick, Michael J |e verfasserin |4 aut | |
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| 700 | 1 | |a Srinivas, Pavithra |e verfasserin |4 aut | |
| 700 | 1 | |a Schulz, Lucas T |e verfasserin |4 aut | |
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