Serveur d'exploration COVID et hydrochloroquine

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COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.

Identifieur interne : 000226 ( Main/Corpus ); précédent : 000225; suivant : 000227

COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.

Auteurs : 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

Source :

RBID : pubmed:33730088

English descriptors

Abstract

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 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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.


DOI: 10.1371/journal.pone.0248128
PubMed: 33730088
PubMed Central: PMC7968637

Links to Exploration step

pubmed:33730088

Le document en format XML

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<name sortKey="Tourassi, Georgia" sort="Tourassi, Georgia" uniqKey="Tourassi G" first="Georgia" last="Tourassi">Georgia Tourassi</name>
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<title xml:lang="en">COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.</title>
<author>
<name sortKey="Stewart, Mark" sort="Stewart, Mark" uniqKey="Stewart M" first="Mark" last="Stewart">Mark Stewart</name>
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<nlm:affiliation>Friends of Cancer Research, Washington, District of Columbia, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Rodriguez Watson, Carla" sort="Rodriguez Watson, Carla" uniqKey="Rodriguez Watson C" first="Carla" last="Rodriguez-Watson">Carla Rodriguez-Watson</name>
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<nlm:affiliation>Reagan-Udall Foundation for the FDA, Washington, District of Columbia, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Albayrak, Adem" sort="Albayrak, Adem" uniqKey="Albayrak A" first="Adem" last="Albayrak">Adem Albayrak</name>
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<nlm:affiliation>Health Catalyst, Salt Lake City, Utah, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Asubonteng, Julius" sort="Asubonteng, Julius" uniqKey="Asubonteng J" first="Julius" last="Asubonteng">Julius Asubonteng</name>
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<nlm:affiliation>Gilead Science, Inc. Foster City, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Belli, Andrew" sort="Belli, Andrew" uniqKey="Belli A" first="Andrew" last="Belli">Andrew Belli</name>
<affiliation>
<nlm:affiliation>COTA, Inc., Boston, Massachusetts, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Brown, Thomas" sort="Brown, Thomas" uniqKey="Brown T" first="Thomas" last="Brown">Thomas Brown</name>
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<nlm:affiliation>Syapse, San Francisco, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Cho, Kelly" sort="Cho, Kelly" uniqKey="Cho K" first="Kelly" last="Cho">Kelly Cho</name>
<affiliation>
<nlm:affiliation>Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, Massachusetts, United States of America.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Das, Ritankar" sort="Das, Ritankar" uniqKey="Das R" first="Ritankar" last="Das">Ritankar Das</name>
<affiliation>
<nlm:affiliation>Dascena, Oakland, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Eldridge, Elizabeth" sort="Eldridge, Elizabeth" uniqKey="Eldridge E" first="Elizabeth" last="Eldridge">Elizabeth Eldridge</name>
<affiliation>
<nlm:affiliation>Health Catalyst, Salt Lake City, Utah, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Gatto, Nicolle" sort="Gatto, Nicolle" uniqKey="Gatto N" first="Nicolle" last="Gatto">Nicolle Gatto</name>
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<nlm:affiliation>Aetion, New York, New York, United States of America.</nlm:affiliation>
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<name sortKey="Gelman, Alice" sort="Gelman, Alice" uniqKey="Gelman A" first="Alice" last="Gelman">Alice Gelman</name>
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<nlm:affiliation>Health Catalyst, Salt Lake City, Utah, United States of America.</nlm:affiliation>
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<name sortKey="Gerlovin, Hanna" sort="Gerlovin, Hanna" uniqKey="Gerlovin H" first="Hanna" last="Gerlovin">Hanna Gerlovin</name>
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<nlm:affiliation>Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, Massachusetts, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Goldberg, Stuart L" sort="Goldberg, Stuart L" uniqKey="Goldberg S" first="Stuart L" last="Goldberg">Stuart L. Goldberg</name>
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</affiliation>
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<name sortKey="Hansen, Eric" sort="Hansen, Eric" uniqKey="Hansen E" first="Eric" last="Hansen">Eric Hansen</name>
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<nlm:affiliation>COTA, Inc., Boston, Massachusetts, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Hirsch, Jonathan" sort="Hirsch, Jonathan" uniqKey="Hirsch J" first="Jonathan" last="Hirsch">Jonathan Hirsch</name>
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<nlm:affiliation>Syapse, San Francisco, California, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Ho, Yuk Lam" sort="Ho, Yuk Lam" uniqKey="Ho Y" first="Yuk-Lam" last="Ho">Yuk-Lam Ho</name>
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</affiliation>
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<name sortKey="Ip, Andrew" sort="Ip, Andrew" uniqKey="Ip A" first="Andrew" last="Ip">Andrew Ip</name>
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<nlm:affiliation>Division of Outcomes and Value Research, John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Izano, Monika" sort="Izano, Monika" uniqKey="Izano M" first="Monika" last="Izano">Monika Izano</name>
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<name sortKey="Jones, Jason" sort="Jones, Jason" uniqKey="Jones J" first="Jason" last="Jones">Jason Jones</name>
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<name sortKey="Justice, Amy C" sort="Justice, Amy C" uniqKey="Justice A" first="Amy C" last="Justice">Amy C. Justice</name>
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<nlm:affiliation>VA Connecticut Healthcare System, West Haven, Connecticut, United States of America.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Yale University Schools of Medicine and Public Health, New Haven, Connecticut, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Klesh, Reyna" sort="Klesh, Reyna" uniqKey="Klesh R" first="Reyna" last="Klesh">Reyna Klesh</name>
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<name sortKey="Kuranz, Seth" sort="Kuranz, Seth" uniqKey="Kuranz S" first="Seth" last="Kuranz">Seth Kuranz</name>
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<nlm:affiliation>TriNetX, Cambridge, Massachusetts, United States of America.</nlm:affiliation>
</affiliation>
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<name sortKey="Lam, Carson" sort="Lam, Carson" uniqKey="Lam C" first="Carson" last="Lam">Carson Lam</name>
<affiliation>
<nlm:affiliation>Dascena, Oakland, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Mao, Qingqing" sort="Mao, Qingqing" uniqKey="Mao Q" first="Qingqing" last="Mao">Qingqing Mao</name>
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<nlm:affiliation>Dascena, Oakland, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Mataraso, Samson" sort="Mataraso, Samson" uniqKey="Mataraso S" first="Samson" last="Mataraso">Samson Mataraso</name>
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<nlm:affiliation>Dascena, Oakland, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Mera, Robertino" sort="Mera, Robertino" uniqKey="Mera R" first="Robertino" last="Mera">Robertino Mera</name>
<affiliation>
<nlm:affiliation>Gilead Science, Inc. Foster City, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Posner, Daniel C" sort="Posner, Daniel C" uniqKey="Posner D" first="Daniel C" last="Posner">Daniel C. Posner</name>
<affiliation>
<nlm:affiliation>Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, Massachusetts, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Rassen, Jeremy A" sort="Rassen, Jeremy A" uniqKey="Rassen J" first="Jeremy A" last="Rassen">Jeremy A. Rassen</name>
<affiliation>
<nlm:affiliation>Aetion, New York, New York, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Siefkas, Anna" sort="Siefkas, Anna" uniqKey="Siefkas A" first="Anna" last="Siefkas">Anna Siefkas</name>
<affiliation>
<nlm:affiliation>Dascena, Oakland, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Schrag, Andrew" sort="Schrag, Andrew" uniqKey="Schrag A" first="Andrew" last="Schrag">Andrew Schrag</name>
<affiliation>
<nlm:affiliation>Syapse, San Francisco, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Tourassi, Georgia" sort="Tourassi, Georgia" uniqKey="Tourassi G" first="Georgia" last="Tourassi">Georgia Tourassi</name>
<affiliation>
<nlm:affiliation>National Center for Computational Sciences Oak Ridge National Laboratory, Oak Ridge, Tennessee, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Weckstein, Andrew" sort="Weckstein, Andrew" uniqKey="Weckstein A" first="Andrew" last="Weckstein">Andrew Weckstein</name>
<affiliation>
<nlm:affiliation>Aetion, New York, New York, United States of America.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Wolf, Frank" sort="Wolf, Frank" uniqKey="Wolf F" first="Frank" last="Wolf">Frank Wolf</name>
<affiliation>
<nlm:affiliation>Syapse, San Francisco, California, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Bhat, Amar" sort="Bhat, Amar" uniqKey="Bhat A" first="Amar" last="Bhat">Amar Bhat</name>
<affiliation>
<nlm:affiliation>Reagan-Udall Foundation for the FDA, Washington, District of Columbia, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Winckler, Susan" sort="Winckler, Susan" uniqKey="Winckler S" first="Susan" last="Winckler">Susan Winckler</name>
<affiliation>
<nlm:affiliation>Reagan-Udall Foundation for the FDA, Washington, District of Columbia, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Sigal, Ellen V" sort="Sigal, Ellen V" uniqKey="Sigal E" first="Ellen V" last="Sigal">Ellen V. Sigal</name>
<affiliation>
<nlm:affiliation>Friends of Cancer Research, Washington, District of Columbia, United States of America.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Reagan-Udall Foundation for the FDA, Washington, District of Columbia, United States of America.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Allen, Jeff" sort="Allen, Jeff" uniqKey="Allen J" first="Jeff" last="Allen">Jeff Allen</name>
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<nlm:affiliation>Friends of Cancer Research, Washington, District of Columbia, United States of America.</nlm:affiliation>
</affiliation>
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<series>
<title level="j">PloS one</title>
<idno type="eISSN">1932-6203</idno>
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<date when="2021" type="published">2021</date>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Antiviral Agents (therapeutic use)</term>
<term>Azithromycin (therapeutic use)</term>
<term>COVID-19 (drug therapy)</term>
<term>Data Management (methods)</term>
<term>Drug Therapy, Combination (methods)</term>
<term>Female (MeSH)</term>
<term>Hospitalization (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>Male (MeSH)</term>
<term>Pandemics (prevention & control)</term>
<term>SARS-CoV-2 (drug effects)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Antiviral Agents</term>
<term>Azithromycin</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en">
<term>SARS-CoV-2</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>COVID-19</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Data Management</term>
<term>Drug Therapy, Combination</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en">
<term>Pandemics</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Female</term>
<term>Hospitalization</term>
<term>Humans</term>
<term>Male</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSION</b>
</p>
<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.</p>
</div>
</front>
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<Day>30</Day>
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<Year>2021</Year>
<Month>04</Month>
<Day>02</Day>
</DateRevised>
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<ISSN IssnType="Electronic">1932-6203</ISSN>
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<Volume>16</Volume>
<Issue>3</Issue>
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<ArticleTitle>COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.</ArticleTitle>
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<AbstractText Label="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 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.</AbstractText>
<AbstractText Label="METHODS">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.</AbstractText>
<AbstractText Label="RESULTS">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.</AbstractText>
<AbstractText Label="CONCLUSION">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.</AbstractText>
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<CoiStatement>The authors have read the journal’s policy and the authors of this manuscript have the following competing interests: AA is a paid employee and stockholder at Health Catalyst. JA is a paid employee and stockholder at Gilead Sciences. AB is a paid employee of COTA, Inc with ownership interest (equity). TB is a paid employee of Sypase. NG is a paid employee and shareholder of Aetion, Inc. SG has equity ownership with COTA, Inc. EH is a paid employee by COTA, Inc. with ownership interest (equity). JH is Founder and President of Syapse with pharmaceutical company funders including Roche, Amgen, Merck & Co. (Syapse employees engaged in design, collection, analysis, interpretation, writing, and the decision to submit for publication). JH also reported being an advisor for Freenome. MI is a paid employee of Syapse. SK is a paid employee of TriNetX, LLC. RM is a paid employee and shareholder of Gilead Sciences. JR is a paid employee of and shareholder in Aetion, Inc., a company that makes software for the analysis of real-world data. AW is an employee and shareholder of Aetion, Inc., a company that makes software for the analysis of real-world data. This does not alter our adherence to PLOS One policies on sharing data and material. There are no patents, products in development, or marketed products associated with this research to declare.</CoiStatement>
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