Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
Identifieur interne : 000C35 ( Main/Exploration ); précédent : 000C34; suivant : 000C36Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
Auteurs : Sarah M. Lofgren [États-Unis] ; Melanie R. Nicol [États-Unis] ; Ananta S. Bangdiwala [États-Unis] ; Katelyn A. Pastick [États-Unis] ; Elizabeth C. Okafor [États-Unis] ; Caleb P. Skipper [États-Unis] ; Matthew F. Pullen [États-Unis] ; Nicole W. Engen [États-Unis] ; Mahsa Abassi [États-Unis] ; Darlisha A. Williams [États-Unis] ; Alanna A. Nascene [États-Unis] ; Margaret L. Axelrod [États-Unis] ; Sylvain A. Lother [Canada] ; Lauren J. Mackenzie [Canada] ; Glen Drobot [Canada] ; Nicole Marten [Canada] ; Matthew P. Cheng [Canada] ; Ryan Zarychanski [Canada] ; Ilan S. Schwartz [Canada] ; Michael Silverman [Canada] ; Zain Chagla [Canada] ; Lauren E. Kelly [Canada] ; Emily G. Mcdonald [Canada] ; Todd C. Lee [Canada] ; Kathy H. Hullsiek [États-Unis] ; David R. Boulware [États-Unis] ; Radha Rajasingham [États-Unis]Source :
- Open forum infectious diseases [ 2328-8957 ] ; 2020.
Abstract
Background
Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials.
Methods
We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings.
Results
We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred.
Conclusions
Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19.
ClinicalTrialsgov Identifier
NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial.
DOI: 10.1093/ofid/ofaa500
PubMed: 33204764
PubMed Central: PMC7654376
Affiliations:
- Canada, États-Unis
- Manitoba, Minnesota, Ontario, Québec, Tennessee
- Hamilton (Ontario), Montréal, Winnipeg
- Université McGill, Université McMaster, Université du Manitoba
Links toward previous steps (curation, corpus...)
Le document en format XML
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Hullsiek</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Boulware, David R" sort="Boulware, David R" uniqKey="Boulware D" first="David R" last="Boulware">David R. Boulware</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33204764</idno><idno type="pmid">33204764</idno><idno type="doi">10.1093/ofid/ofaa500</idno><idno type="pmc">PMC7654376</idno><idno type="wicri:Area/Main/Corpus">000808</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000808</idno><idno type="wicri:Area/Main/Curation">000808</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000808</idno><idno type="wicri:Area/Main/Exploration">000808</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.</title><author><name sortKey="Lofgren, Sarah M" sort="Lofgren, Sarah M" uniqKey="Lofgren S" first="Sarah M" last="Lofgren">Sarah M. Lofgren</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Nicol, Melanie R" sort="Nicol, Melanie R" uniqKey="Nicol M" first="Melanie R" last="Nicol">Melanie R. Nicol</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Bangdiwala, Ananta S" sort="Bangdiwala, Ananta S" uniqKey="Bangdiwala A" first="Ananta S" last="Bangdiwala">Ananta S. Bangdiwala</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Pastick, Katelyn A" sort="Pastick, Katelyn A" uniqKey="Pastick K" first="Katelyn A" last="Pastick">Katelyn A. Pastick</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Okafor, Elizabeth C" sort="Okafor, Elizabeth C" uniqKey="Okafor E" first="Elizabeth C" last="Okafor">Elizabeth C. Okafor</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Skipper, Caleb P" sort="Skipper, Caleb P" uniqKey="Skipper C" first="Caleb P" last="Skipper">Caleb P. Skipper</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Pullen, Matthew F" sort="Pullen, Matthew F" uniqKey="Pullen M" first="Matthew F" last="Pullen">Matthew F. Pullen</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Engen, Nicole W" sort="Engen, Nicole W" uniqKey="Engen N" first="Nicole W" last="Engen">Nicole W. Engen</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Abassi, Mahsa" sort="Abassi, Mahsa" uniqKey="Abassi M" first="Mahsa" last="Abassi">Mahsa Abassi</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Williams, Darlisha A" sort="Williams, Darlisha A" uniqKey="Williams D" first="Darlisha A" last="Williams">Darlisha A. Williams</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Nascene, Alanna A" sort="Nascene, Alanna A" uniqKey="Nascene A" first="Alanna A" last="Nascene">Alanna A. Nascene</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Axelrod, Margaret L" sort="Axelrod, Margaret L" uniqKey="Axelrod M" first="Margaret L" last="Axelrod">Margaret L. Axelrod</name><affiliation wicri:level="2"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, Tennessee, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Vanderbilt University Medical Center, Nashville, Tennessee</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Lother, Sylvain A" sort="Lother, Sylvain A" uniqKey="Lother S" first="Sylvain A" last="Lother">Sylvain A. Lother</name><affiliation wicri:level="4"><nlm:affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba</wicri:regionArea><orgName type="university">Université du Manitoba</orgName><placeName><settlement type="city">Winnipeg</settlement><region type="state">Manitoba</region></placeName></affiliation></author><author><name sortKey="Mackenzie, Lauren J" sort="Mackenzie, Lauren J" uniqKey="Mackenzie L" first="Lauren J" last="Mackenzie">Lauren J. Mackenzie</name><affiliation wicri:level="4"><nlm:affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba</wicri:regionArea><orgName type="university">Université du Manitoba</orgName><placeName><settlement type="city">Winnipeg</settlement><region type="state">Manitoba</region></placeName></affiliation></author><author><name sortKey="Drobot, Glen" sort="Drobot, Glen" uniqKey="Drobot G" first="Glen" last="Drobot">Glen Drobot</name><affiliation wicri:level="4"><nlm:affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba</wicri:regionArea><orgName type="university">Université du Manitoba</orgName><placeName><settlement type="city">Winnipeg</settlement><region type="state">Manitoba</region></placeName></affiliation></author><author><name sortKey="Marten, Nicole" sort="Marten, Nicole" uniqKey="Marten N" first="Nicole" last="Marten">Nicole Marten</name><affiliation wicri:level="1"><nlm:affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba</wicri:regionArea><wicri:noRegion>Manitoba</wicri:noRegion></affiliation></author><author><name sortKey="Cheng, Matthew P" sort="Cheng, Matthew P" uniqKey="Cheng M" first="Matthew P" last="Cheng">Matthew P. Cheng</name><affiliation wicri:level="1"><nlm:affiliation>Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Research Institute of the McGill University Health Centre, Montreal, Quebec</wicri:regionArea><wicri:noRegion>Quebec</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec</wicri:regionArea><orgName type="university">Université McGill</orgName><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Zarychanski, Ryan" sort="Zarychanski, Ryan" uniqKey="Zarychanski R" first="Ryan" last="Zarychanski">Ryan Zarychanski</name><affiliation wicri:level="4"><nlm:affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba</wicri:regionArea><orgName type="university">Université du Manitoba</orgName><placeName><settlement type="city">Winnipeg</settlement><region type="state">Manitoba</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba</wicri:regionArea><wicri:noRegion>Manitoba</wicri:noRegion></affiliation></author><author><name sortKey="Schwartz, Ilan S" sort="Schwartz, Ilan S" uniqKey="Schwartz I" first="Ilan S" last="Schwartz">Ilan S. Schwartz</name><affiliation wicri:level="1"><nlm:affiliation>Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta</wicri:regionArea><wicri:noRegion>Alberta</wicri:noRegion></affiliation></author><author><name sortKey="Silverman, Michael" sort="Silverman, Michael" uniqKey="Silverman M" first="Michael" last="Silverman">Michael Silverman</name><affiliation wicri:level="2"><nlm:affiliation>Lawson Research Institute, St. Joseph's Healthcare Center, London, Ontario.</nlm:affiliation><country>Canada</country><placeName><region type="province">Ontario</region></placeName><wicri:cityArea>Lawson Research Institute, St. Joseph's Healthcare Center, London</wicri:cityArea></affiliation></author><author><name sortKey="Chagla, Zain" sort="Chagla, Zain" uniqKey="Chagla Z" first="Zain" last="Chagla">Zain Chagla</name><affiliation wicri:level="4"><nlm:affiliation>McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Kelly, Lauren E" sort="Kelly, Lauren E" uniqKey="Kelly L" first="Lauren E" last="Kelly">Lauren E. Kelly</name><affiliation wicri:level="1"><nlm:affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba</wicri:regionArea><wicri:noRegion>Manitoba</wicri:noRegion></affiliation></author><author><name sortKey="Mcdonald, Emily G" sort="Mcdonald, Emily G" uniqKey="Mcdonald E" first="Emily G" last="Mcdonald">Emily G. Mcdonald</name><affiliation wicri:level="1"><nlm:affiliation>Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Research Institute of the McGill University Health Centre, Montreal, Quebec</wicri:regionArea><wicri:noRegion>Quebec</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec</wicri:regionArea><orgName type="university">Université McGill</orgName><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Lee, Todd C" sort="Lee, Todd C" uniqKey="Lee T" first="Todd C" last="Lee">Todd C. Lee</name><affiliation wicri:level="1"><nlm:affiliation>Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Research Institute of the McGill University Health Centre, Montreal, Quebec</wicri:regionArea><wicri:noRegion>Quebec</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec</wicri:regionArea><orgName type="university">Université McGill</orgName><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Hullsiek, Kathy H" sort="Hullsiek, Kathy H" uniqKey="Hullsiek K" first="Kathy H" last="Hullsiek">Kathy H. Hullsiek</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Boulware, David R" sort="Boulware, David R" uniqKey="Boulware D" first="David R" last="Boulware">David R. Boulware</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author></analytic><series><title level="j">Open forum infectious diseases</title><idno type="ISSN">2328-8957</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>Background</b></p><p>Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials.</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings.</p></div><div type="abstract" xml:lang="en"><p><b>Results</b></p><p>We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred.</p></div><div type="abstract" xml:lang="en"><p><b>Conclusions</b></p><p>Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>ClinicalTrialsgov Identifier</b></p><p>NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33204764</PMID><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>11</Issue><PubDate><Year>2020</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Open forum infectious diseases</Title><ISOAbbreviation>Open Forum Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.</ArticleTitle><Pagination><MedlinePgn>ofaa500</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/ofid/ofaa500</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials.</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred.</AbstractText><AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19.</AbstractText><AbstractText Label="ClinicalTrialsgov Identifier" NlmCategory="UNASSIGNED">NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial.</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>Lofgren</LastName><ForeName>Sarah M</ForeName><Initials>SM</Initials><Identifier Source="ORCID">0000-0001-6717-2614</Identifier><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nicol</LastName><ForeName>Melanie R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bangdiwala</LastName><ForeName>Ananta S</ForeName><Initials>AS</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pastick</LastName><ForeName>Katelyn A</ForeName><Initials>KA</Initials><Identifier Source="ORCID">0000-0002-1306-1713</Identifier><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Okafor</LastName><ForeName>Elizabeth C</ForeName><Initials>EC</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Skipper</LastName><ForeName>Caleb P</ForeName><Initials>CP</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pullen</LastName><ForeName>Matthew F</ForeName><Initials>MF</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Engen</LastName><ForeName>Nicole W</ForeName><Initials>NW</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abassi</LastName><ForeName>Mahsa</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Williams</LastName><ForeName>Darlisha A</ForeName><Initials>DA</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nascene</LastName><ForeName>Alanna A</ForeName><Initials>AA</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Axelrod</LastName><ForeName>Margaret L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Vanderbilt University Medical Center, Nashville, Tennessee, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lother</LastName><ForeName>Sylvain A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>MacKenzie</LastName><ForeName>Lauren J</ForeName><Initials>LJ</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Drobot</LastName><ForeName>Glen</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marten</LastName><ForeName>Nicole</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cheng</LastName><ForeName>Matthew P</ForeName><Initials>MP</Initials><AffiliationInfo><Affiliation>Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zarychanski</LastName><ForeName>Ryan</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schwartz</LastName><ForeName>Ilan S</ForeName><Initials>IS</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Silverman</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Lawson Research Institute, St. Joseph's Healthcare Center, London, Ontario.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chagla</LastName><ForeName>Zain</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kelly</LastName><ForeName>Lauren E</ForeName><Initials>LE</Initials><AffiliationInfo><Affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McDonald</LastName><ForeName>Emily G</ForeName><Initials>EG</Initials><AffiliationInfo><Affiliation>Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Todd C</ForeName><Initials>TC</Initials><AffiliationInfo><Affiliation>Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hullsiek</LastName><ForeName>Kathy H</ForeName><Initials>KH</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boulware</LastName><ForeName>David R</ForeName><Initials>DR</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rajasingham</LastName><ForeName>Radha</ForeName><Initials>R</Initials><Identifier Source="ORCID">0000-0001-5531-0231</Identifier><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04328467</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>R01 NS110519</GrantID><Acronym>NS</Acronym><Agency>NINDS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>R01 NS086312</GrantID><Acronym>NS</Acronym><Agency>NINDS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>UL1 TR002494</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>K23 AI138851</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>U01 AI125003</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>T32 GM007347</GrantID><Acronym>GM</Acronym><Agency>NIGMS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>L30 TW011500</GrantID><Acronym>TW</Acronym><Agency>FIC NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>K23 MH121220</GrantID><Acronym>MH</Acronym><Agency>NIMH NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>K08 AI134262</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>10</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Open Forum Infect Dis</MedlineTA><NlmUniqueID>101637045</NlmUniqueID><ISSNLinking>2328-8957</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="UpdateOf"><RefSource>medRxiv. 2020 Jul 23;:</RefSource><PMID Version="1">32743591</PMID></CommentsCorrections></CommentsCorrectionsList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">COVID-19</Keyword><Keyword MajorTopicYN="Y">SARS-Cov2</Keyword><Keyword MajorTopicYN="Y">hydroxychloroquine</Keyword><Keyword MajorTopicYN="Y">safety</Keyword><Keyword MajorTopicYN="Y">side effects</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>07</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>10</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>11</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>11</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>11</Month><Day>19</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33204764</ArticleId><ArticleId IdType="doi">10.1093/ofid/ofaa500</ArticleId><ArticleId IdType="pii">ofaa500</ArticleId><ArticleId IdType="pmc">PMC7654376</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>CMAJ. 2020 Apr 27;192(17):E450-E453</Citation><ArticleIdList><ArticleId IdType="pubmed">32269021</ArticleId></ArticleIdList></Reference><Reference><Citation>J Am Geriatr Soc. 2020 Aug;68(8):1636-1646</Citation><ArticleIdList><ArticleId IdType="pubmed">32441771</ArticleId></ArticleIdList></Reference><Reference><Citation>Arthritis Rheum. 2002 Jun;46(6):1460-9</Citation><ArticleIdList><ArticleId IdType="pubmed">12115175</ArticleId></ArticleIdList></Reference><Reference><Citation>J Cell Physiol. 2020 Dec;235(12):9884-9894</Citation><ArticleIdList><ArticleId IdType="pubmed">32510598</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 Aug 6;383(6):517-525</Citation><ArticleIdList><ArticleId IdType="pubmed">32492293</ArticleId></ArticleIdList></Reference><Reference><Citation>Heart Rhythm. 2020 Jul;17(7):e231-e232</Citation><ArticleIdList><ArticleId IdType="pubmed">32302703</ArticleId></ArticleIdList></Reference><Reference><Citation>Open Forum Infect Dis. 2020 Apr 15;7(4):ofaa130</Citation><ArticleIdList><ArticleId IdType="pubmed">32363212</ArticleId></ArticleIdList></Reference><Reference><Citation>Heart Lung Circ. 2020 Jul;29(7):973-987</Citation><ArticleIdList><ArticleId IdType="pubmed">32601020</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Rheumatol. 2013 Aug;19(5):286-8</Citation><ArticleIdList><ArticleId IdType="pubmed">23872551</ArticleId></ArticleIdList></Reference><Reference><Citation>Arch Cardiovasc Dis. 2020 May;113(5):293-296</Citation><ArticleIdList><ArticleId IdType="pubmed">32354666</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Pharmacol Ther. 2020 Oct;108(4):766-769</Citation><ArticleIdList><ArticleId IdType="pubmed">32344449</ArticleId></ArticleIdList></Reference><Reference><Citation>Rheumatology (Oxford). 2016 Jun;55(6):957-67</Citation><ArticleIdList><ArticleId IdType="pubmed">26428520</ArticleId></ArticleIdList></Reference><Reference><Citation>Biochem Pharmacol. 2020 Aug;178:114114</Citation><ArticleIdList><ArticleId IdType="pubmed">32579957</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Infect Dis. 2020 Oct 17;:</Citation><ArticleIdList><ArticleId IdType="pubmed">33068425</ArticleId></ArticleIdList></Reference><Reference><Citation>JAMA Cardiol. 2020 Sep 1;5(9):1036-1041</Citation><ArticleIdList><ArticleId IdType="pubmed">32936252</ArticleId></ArticleIdList></Reference><Reference><Citation>Ann Clin Biochem. 2020 May;57(3):262-265</Citation><ArticleIdList><ArticleId IdType="pubmed">32266828</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Infect Dis. 2020 Jul 28;71(15):732-739</Citation><ArticleIdList><ArticleId IdType="pubmed">32150618</ArticleId></ArticleIdList></Reference><Reference><Citation>Ann Intern Med. 2020 Oct 20;173(8):623-631</Citation><ArticleIdList><ArticleId IdType="pubmed">32673060</ArticleId></ArticleIdList></Reference><Reference><Citation>Ther Adv Infect Dis. 2013 Oct;1(5):155-65</Citation><ArticleIdList><ArticleId IdType="pubmed">25165550</ArticleId></ArticleIdList></Reference><Reference><Citation>JAMA Netw Open. 2020 Apr 24;3(4):e208857</Citation><ArticleIdList><ArticleId IdType="pubmed">32330277</ArticleId></ArticleIdList></Reference><Reference><Citation>Heart. 2003 Nov;89(11):1363-72</Citation><ArticleIdList><ArticleId IdType="pubmed">14594906</ArticleId></ArticleIdList></Reference><Reference><Citation>CMAJ. 2020 Apr 14;192(15):E405-E407</Citation><ArticleIdList><ArticleId IdType="pubmed">32336678</ArticleId></ArticleIdList></Reference><Reference><Citation>Chin Med J. 1964 Aug;83:531-5</Citation><ArticleIdList><ArticleId IdType="pubmed">14174540</ArticleId></ArticleIdList></Reference><Reference><Citation>Can J Cardiol. 2020 Jun;36(6):948-951</Citation><ArticleIdList><ArticleId IdType="pubmed">32299753</ArticleId></ArticleIdList></Reference><Reference><Citation>Am J Emerg Med. 2020 Jul;38(7):1488-1493</Citation><ArticleIdList><ArticleId IdType="pubmed">32336586</ArticleId></ArticleIdList></Reference><Reference><Citation>Virol J. 2005 Aug 22;2:69</Citation><ArticleIdList><ArticleId IdType="pubmed">16115318</ArticleId></ArticleIdList></Reference><Reference><Citation>Cell Rep Med. 2020 Jul 21;1(4):100052</Citation><ArticleIdList><ArticleId IdType="pubmed">32835305</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Canada</li><li>États-Unis</li></country><region><li>Manitoba</li><li>Minnesota</li><li>Ontario</li><li>Québec</li><li>Tennessee</li></region><settlement><li>Hamilton (Ontario)</li><li>Montréal</li><li>Winnipeg</li></settlement><orgName><li>Université McGill</li><li>Université McMaster</li><li>Université du Manitoba</li></orgName></list><tree><country name="États-Unis"><region name="Minnesota"><name sortKey="Lofgren, Sarah M" sort="Lofgren, Sarah M" uniqKey="Lofgren S" first="Sarah M" last="Lofgren">Sarah M. Lofgren</name></region><name sortKey="Abassi, Mahsa" sort="Abassi, Mahsa" uniqKey="Abassi M" first="Mahsa" last="Abassi">Mahsa Abassi</name><name sortKey="Axelrod, Margaret L" sort="Axelrod, Margaret L" uniqKey="Axelrod M" first="Margaret L" last="Axelrod">Margaret L. Axelrod</name><name sortKey="Bangdiwala, Ananta S" sort="Bangdiwala, Ananta S" uniqKey="Bangdiwala A" first="Ananta S" last="Bangdiwala">Ananta S. Bangdiwala</name><name sortKey="Boulware, David R" sort="Boulware, David R" uniqKey="Boulware D" first="David R" last="Boulware">David R. Boulware</name><name sortKey="Engen, Nicole W" sort="Engen, Nicole W" uniqKey="Engen N" first="Nicole W" last="Engen">Nicole W. Engen</name><name sortKey="Hullsiek, Kathy H" sort="Hullsiek, Kathy H" uniqKey="Hullsiek K" first="Kathy H" last="Hullsiek">Kathy H. Hullsiek</name><name sortKey="Nascene, Alanna A" sort="Nascene, Alanna A" uniqKey="Nascene A" first="Alanna A" last="Nascene">Alanna A. Nascene</name><name sortKey="Nicol, Melanie R" sort="Nicol, Melanie R" uniqKey="Nicol M" first="Melanie R" last="Nicol">Melanie R. Nicol</name><name sortKey="Okafor, Elizabeth C" sort="Okafor, Elizabeth C" uniqKey="Okafor E" first="Elizabeth C" last="Okafor">Elizabeth C. Okafor</name><name sortKey="Pastick, Katelyn A" sort="Pastick, Katelyn A" uniqKey="Pastick K" first="Katelyn A" last="Pastick">Katelyn A. Pastick</name><name sortKey="Pullen, Matthew F" sort="Pullen, Matthew F" uniqKey="Pullen M" first="Matthew F" last="Pullen">Matthew F. Pullen</name><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name><name sortKey="Skipper, Caleb P" sort="Skipper, Caleb P" uniqKey="Skipper C" first="Caleb P" last="Skipper">Caleb P. Skipper</name><name sortKey="Williams, Darlisha A" sort="Williams, Darlisha A" uniqKey="Williams D" first="Darlisha A" last="Williams">Darlisha A. Williams</name></country><country name="Canada"><region name="Manitoba"><name sortKey="Lother, Sylvain A" sort="Lother, Sylvain A" uniqKey="Lother S" first="Sylvain A" last="Lother">Sylvain A. Lother</name></region><name sortKey="Chagla, Zain" sort="Chagla, Zain" uniqKey="Chagla Z" first="Zain" last="Chagla">Zain Chagla</name><name sortKey="Cheng, Matthew P" sort="Cheng, Matthew P" uniqKey="Cheng M" first="Matthew P" last="Cheng">Matthew P. Cheng</name><name sortKey="Cheng, Matthew P" sort="Cheng, Matthew P" uniqKey="Cheng M" first="Matthew P" last="Cheng">Matthew P. Cheng</name><name sortKey="Drobot, Glen" sort="Drobot, Glen" uniqKey="Drobot G" first="Glen" last="Drobot">Glen Drobot</name><name sortKey="Kelly, Lauren E" sort="Kelly, Lauren E" uniqKey="Kelly L" first="Lauren E" last="Kelly">Lauren E. Kelly</name><name sortKey="Lee, Todd C" sort="Lee, Todd C" uniqKey="Lee T" first="Todd C" last="Lee">Todd C. Lee</name><name sortKey="Lee, Todd C" sort="Lee, Todd C" uniqKey="Lee T" first="Todd C" last="Lee">Todd C. Lee</name><name sortKey="Mackenzie, Lauren J" sort="Mackenzie, Lauren J" uniqKey="Mackenzie L" first="Lauren J" last="Mackenzie">Lauren J. Mackenzie</name><name sortKey="Marten, Nicole" sort="Marten, Nicole" uniqKey="Marten N" first="Nicole" last="Marten">Nicole Marten</name><name sortKey="Mcdonald, Emily G" sort="Mcdonald, Emily G" uniqKey="Mcdonald E" first="Emily G" last="Mcdonald">Emily G. Mcdonald</name><name sortKey="Mcdonald, Emily G" sort="Mcdonald, Emily G" uniqKey="Mcdonald E" first="Emily G" last="Mcdonald">Emily G. Mcdonald</name><name sortKey="Schwartz, Ilan S" sort="Schwartz, Ilan S" uniqKey="Schwartz I" first="Ilan S" last="Schwartz">Ilan S. Schwartz</name><name sortKey="Silverman, Michael" sort="Silverman, Michael" uniqKey="Silverman M" first="Michael" last="Silverman">Michael Silverman</name><name sortKey="Zarychanski, Ryan" sort="Zarychanski, Ryan" uniqKey="Zarychanski R" first="Ryan" last="Zarychanski">Ryan Zarychanski</name><name sortKey="Zarychanski, Ryan" sort="Zarychanski, Ryan" uniqKey="Zarychanski R" first="Ryan" last="Zarychanski">Ryan Zarychanski</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/CovidChloroV1/Data/Main/Exploration
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Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000C35 | SxmlIndent | more
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{{Explor lien
|wiki= Sante
|area= CovidChloroV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= pubmed:33204764
|texte= Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:33204764" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a CovidChloroV1
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