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

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

bioRxiv.org - (2021) vom: 03. Jan. Zur Gesamtaufnahme - year:2021

Sprache:

Englisch

Beteiligte Personen:

Rhodes, Nathaniel J. [VerfasserIn]
Dairem, Atheer [VerfasserIn]
Moore, William J. [VerfasserIn]
Shah, Anooj [VerfasserIn]
Postelnick, Michael J. [VerfasserIn]
Badowski, Melissa E. [VerfasserIn]
Michienzi, Sarah M. [VerfasserIn]
Borkowski, Jaime L. [VerfasserIn]
Polisetty, Radhika S. [VerfasserIn]
Fong, Karen [VerfasserIn]
Spivak, Emily S. [VerfasserIn]
Beardsley, James R. [VerfasserIn]
Hale, Cory M. [VerfasserIn]
Pallotta, Andrea M. [VerfasserIn]
Srinivas, Pavithra [VerfasserIn]
Schulz, Lucas T. [VerfasserIn]

Links:

Volltext [kostenfrei]

doi:

10.1101/2020.06.03.20121558

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

XBI018075940