Quantifying treatment effects of hydroxychloroquine and azithromycin for COVID-19: a secondary analysis of an open label non-randomized clinical trial (Gautret et al., 2020)

{ 'institution': [{'name': 'medRxiv'}], 'indexed': {'date-parts': [[2023, 6, 23]], 'date-time': '2023-06-23T14:10:26Z', 'timestamp': 1687529426946}, 'posted': {'date-parts': [[2020, 3, 27]]}, 'group-title': 'Epidemiology', 'reference-count': 14, 'publisher': 'Cold Spring Harbor Laboratory', 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'accepted': {'date-parts': [[2020, 4, 10]]}, 'abstract': '<jats:title>A<jats:sc>bstract</jats:sc></jats:title><jats:p>Human infections with a novel ' 'coronavirus (SARS-CoV-2) were first identified via syndromic surveillance in December of 2019 ' 'in Wuhan China. Since identification, infections (coronavirus disease-2019; COVID-19) caused ' 'by this novel pathogen have spread globally, with more than 250,000 confirmed cases as of ' 'March 21, 2020. An open-label clinical trial has just concluded, suggesting improved ' 'resolution of viremia with use of two existing therapies: hydroxychloroquine (HCQ) as ' 'monotherapy, and in combination with azithromycin (HCQ-AZ). [3, 4].</jats:p><jats:p>The ' 'results of this important trial have major implications for global policy in the rapid ' 'scale-up and response to this pandemic. The authors present results with p-values for ' 'differences in proportions between the study arms, but their analysis is not able to provide ' 'effect size estimates.</jats:p><jats:p>To address this gap, more modern analytical methods ' 'including survival models, have been applied to these data, and show modest to no impact of ' 'HCQ treatment, with more significant effects from the HCQ-AZ combination, potentially ' 'suggesting a role for co-infections in COVID-19 pathogenesis.</jats:p><jats:p>The trial of ' 'Gautret and colleagues, with consideration of the effect sizes, and p-values from multiple ' 'models, does not provide sufficient evidence to support wide-scale rollout of HCQ monotherapy ' 'for the treatment of COVID-19; larger randomized studies should be considered. These data ' 'also suggest further randomized-controlled studies of HCQ-AZ combination therapy should be ' 'undertaken.</jats:p>', 'DOI': '10.1101/2020.03.22.20040949', 'type': 'posted-content', 'created': {'date-parts': [[2020, 3, 27]], 'date-time': '2020-03-27T17:55:42Z', 'timestamp': 1585331742000}, 'source': 'Crossref', 'is-referenced-by-count': 14, 'title': 'Quantifying treatment effects of hydroxychloroquine and azithromycin for COVID-19: a secondary ' 'analysis of an open label non-randomized clinical trial', 'prefix': '10.1101', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-2181-3559', 'authenticated-orcid': False, 'given': 'Andrew A.', 'family': 'Lover', 'sequence': 'first', 'affiliation': []}], 'member': '246', 'reference': [ { 'key': '2020112112000956000_2020.03.22.20040949v2.1', 'unstructured': 'Elisabeth Bik. Thoughts on the Gautret et al. paper about ' 'Hydroxychloroquine and Azithromycin treatment of COVID-19 infections. ' 'Technical report, March 2020. 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