Serveur d'exploration COVID et hydrochloroquine

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Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients.

Identifieur interne : 000906 ( Main/Corpus ); précédent : 000905; suivant : 000907

Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients.

Auteurs : Robert J. Ulrich ; Andrea B. Troxel ; Ellie Carmody ; Jaishvi Eapen ; Martin B Cker ; Jack A. Dehovitz ; Prithiv J. Prasad ; Yi Li ; Camila Delgado ; Morris Jrada ; Gabriel A. Robbins ; Brooklyn Henderson ; Alexander Hrycko ; Dinuli Delpachitra ; Vanessa Raabe ; Jonathan S. Austrian ; Yanina Dubrovskaya ; Mark J. Mulligan

Source :

RBID : pubmed:33134417

Abstract

Background

Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19.

Methods

We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14.

Results

A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (

Conclusions

In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.


DOI: 10.1093/ofid/ofaa446
PubMed: 33134417
PubMed Central: PMC7543602

Links to Exploration step

pubmed:33134417

Le document en format XML

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<nlm:affiliation>Department of Pharmacy, NYU Langone Health, New York, New York, USA.</nlm:affiliation>
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<nlm:affiliation>Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
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<name sortKey="Li, Yi" sort="Li, Yi" uniqKey="Li Y" first="Yi" last="Li">Yi Li</name>
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<nlm:affiliation>Division of Biostatistics, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
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<name sortKey="Delgado, Camila" sort="Delgado, Camila" uniqKey="Delgado C" first="Camila" last="Delgado">Camila Delgado</name>
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<name sortKey="Jrada, Morris" sort="Jrada, Morris" uniqKey="Jrada M" first="Morris" last="Jrada">Morris Jrada</name>
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</affiliation>
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<name sortKey="Robbins, Gabriel A" sort="Robbins, Gabriel A" uniqKey="Robbins G" first="Gabriel A" last="Robbins">Gabriel A. Robbins</name>
<affiliation>
<nlm:affiliation>Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Division of Pediatric Hematology-Oncology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Henderson, Brooklyn" sort="Henderson, Brooklyn" uniqKey="Henderson B" first="Brooklyn" last="Henderson">Brooklyn Henderson</name>
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<nlm:affiliation>Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Hrycko, Alexander" sort="Hrycko, Alexander" uniqKey="Hrycko A" first="Alexander" last="Hrycko">Alexander Hrycko</name>
<affiliation>
<nlm:affiliation>Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Delpachitra, Dinuli" sort="Delpachitra, Dinuli" uniqKey="Delpachitra D" first="Dinuli" last="Delpachitra">Dinuli Delpachitra</name>
<affiliation>
<nlm:affiliation>Department of Medicine, Division of Infectious Diseases, NYU Long Island School of Medicine, Mineola, New York, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Raabe, Vanessa" sort="Raabe, Vanessa" uniqKey="Raabe V" first="Vanessa" last="Raabe">Vanessa Raabe</name>
<affiliation>
<nlm:affiliation>Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Department of Pediatrics, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Divison of Pediatric Infectious Diseases, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Austrian, Jonathan S" sort="Austrian, Jonathan S" uniqKey="Austrian J" first="Jonathan S" last="Austrian">Jonathan S. Austrian</name>
<affiliation>
<nlm:affiliation>Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Dubrovskaya, Yanina" sort="Dubrovskaya, Yanina" uniqKey="Dubrovskaya Y" first="Yanina" last="Dubrovskaya">Yanina Dubrovskaya</name>
<affiliation>
<nlm:affiliation>Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Department of Pharmacy, NYU Langone Health, New York, New York, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Mulligan, Mark J" sort="Mulligan, Mark J" uniqKey="Mulligan M" first="Mark J" last="Mulligan">Mark J. Mulligan</name>
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<nlm:affiliation>Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation>
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<div type="abstract" xml:lang="en">
<p>
<b>Background</b>
</p>
<p>Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>Methods</b>
</p>
<p>We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>Results</b>
</p>
<p>A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>Conclusions</b>
</p>
<p>In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.</p>
</div>
</front>
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<DateRevised>
<Year>2021</Year>
<Month>04</Month>
<Day>28</Day>
</DateRevised>
<Article PubModel="Electronic-eCollection">
<Journal>
<ISSN IssnType="Print">2328-8957</ISSN>
<JournalIssue CitedMedium="Print">
<Volume>7</Volume>
<Issue>10</Issue>
<PubDate>
<Year>2020</Year>
<Month>Oct</Month>
</PubDate>
</JournalIssue>
<Title>Open forum infectious diseases</Title>
<ISOAbbreviation>Open Forum Infect Dis</ISOAbbreviation>
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<ArticleTitle>Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients.</ArticleTitle>
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<Abstract>
<AbstractText Label="Background" NlmCategory="UNASSIGNED">Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19.</AbstractText>
<AbstractText Label="Methods" NlmCategory="UNASSIGNED">We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14.</AbstractText>
<AbstractText Label="Results" NlmCategory="UNASSIGNED">A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (
<i>P</i>
 = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay.</AbstractText>
<AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.</AbstractText>
<CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Ulrich</LastName>
<ForeName>Robert J</ForeName>
<Initials>RJ</Initials>
<Identifier Source="ORCID">0000-0002-3217-5062</Identifier>
<AffiliationInfo>
<Affiliation>Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Division of Infectious Diseases and Immunology, New York University Grossman School of Medicine, New York, New York, USA.</Affiliation>
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<LastName>Troxel</LastName>
<ForeName>Andrea B</ForeName>
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