COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients
Mark Stewart, Carla Rodriguez-Watson, Adem Albayrak, Julius Asubonteng, Andrew Belli, Thomas Brown, Kelly Cho, Ritankar Das, Elizabeth Eldridge, Nicolle Gatto, Alice Gelman, Hanna Gerlovin, Stuart L Goldberg, Eric Hansen, Jonathan Hirsch, Yuk-Lam Ho, Andrew Ip, Monika Izano, Jason Jones, Amy C Justice, Reyna Klesh, Seth Kuranz, Carson Lam, Qingqing Mao, Samson Mataraso, Robertino Mera, Daniel C Posner, Jeremy A Rassen, Anna Siefkas, Andrew Schrag, Georgia Tourassi, Andrew Weckstein, Frank Wolf, Amar Bhat, Susan Winckler, Ellen V Sigal, Jeff Allen
PLOS ONE, doi:10.1371/journal.pone.0248128
Background The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems
Across all datasets and treatment groups, the most prominent pre-existing conditions tended to be any cardiovascular disease, hypertension, diabetes and obesity. Overall, obesity was more prevalent among the HCQ treatment groups than in the neither group. For most data partners, the proportion of patients treated with any of these comorbidities was lower or no different in the HCQ groups than in the neither group-with the exception of Syapse, which was a cancer cohort. There are several limitations to this study that must be acknowledged. First, despite our goal of carrying out the same set of analyses on multiple datasets, analyses could not be carried COTA/HMH 516 36 ( 7 ) 0 (0) 0 (0) 12 ( 2 ) 0 (0) 5 ) 53 ( 5 ) 36 ( 4 ) 36 ( 4 ) � Adverse event data from discharge diagnoses.
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'abstract': '<jats:sec id="sec001">\n'
'<jats:title>Background</jats:title>\n'
'<jats:p>The COVID-19 pandemic remains a significant global threat. However, despite urgent '
'need, there remains uncertainty surrounding best practices for pharmaceutical interventions '
'to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of '
'hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 '
'Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration '
'with Friends of Cancer Research, assembled experts from the health systems research, '
'regulatory science, data science, and epidemiology to participate in a large parallel '
'analysis of different data sets to further explore the effectiveness of these '
'treatments.</jats:p>\n'
'</jats:sec>\n'
'<jats:sec id="sec002">\n'
'<jats:title>Methods</jats:title>\n'
'<jats:p>Electronic health record (EHR) and claims data were extracted from seven separate '
'databases. Parallel analyses were undertaken on data extracted from each source. Each '
'analysis examined time to mortality in hospitalized patients treated with hydroxychloroquine, '
'azithromycin, and the two in combination as compared to patients not treated with either '
'drug. Cox proportional hazards models were used, and propensity score methods were undertaken '
'to adjust for confounding. Frequencies of adverse events in each treatment group were also '
'examined.</jats:p>\n'
'</jats:sec>\n'
'<jats:sec id="sec003">\n'
'<jats:title>Results</jats:title>\n'
'<jats:p>Neither hydroxychloroquine nor azithromycin, alone or in combination, were '
'significantly associated with time to mortality among hospitalized COVID-19 patients. No '
'treatment groups appeared to have an elevated risk of adverse events.</jats:p>\n'
'</jats:sec>\n'
'<jats:sec id="sec004">\n'
'<jats:title>Conclusion</jats:title>\n'
'<jats:p>Administration of hydroxychloroquine, azithromycin, and their combination appeared to '
'have no effect on time to mortality in hospitalized COVID-19 patients. Continued research is '
'needed to clarify best practices surrounding treatment of COVID-19.</jats:p>\n'
'</jats:sec>',
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