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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Michael Postelnick, Sarah M Michienzi, Andrea Pallotta, Nathaniel J. Rhodes, Karen Fong, Atheer Dairem, William Justin Moore, Jaime L Borkowski, Lucas T Schulz, Anooj Shah, Pavithra Srinivas, Radhika S. Polisetty, Emily S Spivak, Cory M Hale, James Beardsley, and Melissa E Badowski
- Subjects
medicine.medical_specialty ,Combination therapy ,adverse drug reaction ,Prevalence ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,Internal medicine ,medicine ,030212 general & internal medicine ,Pharmacology ,Clinical Report ,business.industry ,SARS-CoV-2 ,Health Policy ,COVID-19 ,Hydroxychloroquine ,Retrospective cohort study ,Odds ratio ,medication safety ,medicine.disease ,Clinical trial ,supportive care ,AcademicSubjects/MED00410 ,observational study ,business ,Adverse drug reaction ,medicine.drug - 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.
- Published
- 2021