Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.
Identifieur interne : 001198 ( Main/Exploration ); précédent : 001197; suivant : 001199Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.
Auteurs : Radha Rajasingham [États-Unis] ; Ananta S. Bangdiwala [États-Unis] ; Melanie R. Nicol [États-Unis] ; Caleb P. Skipper [États-Unis] ; Katelyn A. Pastick [États-Unis] ; Margaret L. Axelrod [États-Unis] ; Matthew F. Pullen [États-Unis] ; Alanna A. Nascene [États-Unis] ; Darlisha A. Williams [États-Unis] ; Nicole W. Engen [États-Unis] ; Elizabeth C. Okafor [États-Unis] ; Brian I. Rini [États-Unis] ; Ingrid A. Mayer [États-Unis] ; Emily G. Mcdonald [Canada] ; Todd C. Lee [Canada] ; Peter Li [États-Unis] ; Lauren J. Mackenzie [Canada] ; Justin M. Balko [États-Unis] ; Stephen J. Dunlop [États-Unis] ; Katherine H. Hullsiek [États-Unis] ; David R. Boulware [États-Unis] ; Sarah M. Lofgren [États-Unis]Source :
- medRxiv : the preprint server for health sciences ; 2020.
Abstract
BACKGROUND
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS CoV-2 in healthcare workers at high-risk of exposure.
METHODS
We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.
RESULTS
We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18) and for twice weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
CONCLUSIONS
Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.
DOI: 10.1101/2020.09.18.20197327
PubMed: 32995820
PubMed Central: PMC7523161
Affiliations:
- Canada, États-Unis
- Manitoba, Minnesota, Oregon, Québec, Tennessee
- Montréal, Portland, Winnipeg
- Université des sciences et de la médecine de l'Oregon, Université du Manitoba
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Nascene</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation></author><author><name sortKey="Rini, Brian I" sort="Rini, Brian I" uniqKey="Rini B" first="Brian I" last="Rini">Brian I. Rini</name><affiliation wicri:level="2"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Vanderbilt University Medical Center, Nashville</wicri:cityArea></affiliation></author><author><name sortKey="Mayer, Ingrid A" sort="Mayer, Ingrid A" uniqKey="Mayer I" first="Ingrid A" last="Mayer">Ingrid A. Mayer</name><affiliation wicri:level="2"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Vanderbilt University Medical Center, Nashville</wicri:cityArea></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="3"><nlm:affiliation>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.</nlm:affiliation><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName><wicri:orgArea>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University</wicri:orgArea></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="3"><nlm:affiliation>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.</nlm:affiliation><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName><wicri:orgArea>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University</wicri:orgArea></affiliation></author><author><name sortKey="Li, Peter" sort="Li, Peter" uniqKey="Li P" first="Peter" last="Li">Peter Li</name><affiliation wicri:level="4"><nlm:affiliation>Oregon Health & Science University, Portland, OR.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Oregon</region><settlement type="city">Portland</settlement></placeName><wicri:cityArea>Oregon Health & Science University, Portland</wicri:cityArea><orgName type="university">Université des sciences et de la médecine de l'Oregon</orgName></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>Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.</nlm:affiliation><orgName type="university">Université du Manitoba</orgName><country>Canada</country><placeName><settlement type="city">Winnipeg</settlement><region type="state">Manitoba</region></placeName></affiliation></author><author><name sortKey="Balko, Justin M" sort="Balko, Justin M" uniqKey="Balko J" first="Justin M" last="Balko">Justin M. Balko</name><affiliation wicri:level="2"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Vanderbilt University Medical Center, Nashville</wicri:cityArea></affiliation></author><author><name sortKey="Dunlop, Stephen J" sort="Dunlop, Stephen J" uniqKey="Dunlop S" first="Stephen J" last="Dunlop">Stephen J. Dunlop</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:affiliation>Hennepin Healthcare, Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Hennepin Healthcare, Minneapolis</wicri:cityArea></affiliation></author><author><name sortKey="Hullsiek, Katherine H" sort="Hullsiek, Katherine H" uniqKey="Hullsiek K" first="Katherine H" last="Hullsiek">Katherine H. Hullsiek</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation></author><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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32995820</idno><idno type="pmid">32995820</idno><idno type="doi">10.1101/2020.09.18.20197327</idno><idno type="pmc">PMC7523161</idno><idno type="wicri:Area/Main/Corpus">000B25</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000B25</idno><idno type="wicri:Area/Main/Curation">000B25</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000B25</idno><idno type="wicri:Area/Main/Exploration">000B25</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.</title><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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Vanderbilt University Medical Center, Nashville</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation></author><author><name sortKey="Rini, Brian I" sort="Rini, Brian I" uniqKey="Rini B" first="Brian I" last="Rini">Brian I. Rini</name><affiliation wicri:level="2"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Vanderbilt University Medical Center, Nashville</wicri:cityArea></affiliation></author><author><name sortKey="Mayer, Ingrid A" sort="Mayer, Ingrid A" uniqKey="Mayer I" first="Ingrid A" last="Mayer">Ingrid A. Mayer</name><affiliation wicri:level="2"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Vanderbilt University Medical Center, Nashville</wicri:cityArea></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="3"><nlm:affiliation>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.</nlm:affiliation><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName><wicri:orgArea>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University</wicri:orgArea></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="3"><nlm:affiliation>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.</nlm:affiliation><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName><wicri:orgArea>Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University</wicri:orgArea></affiliation></author><author><name sortKey="Li, Peter" sort="Li, Peter" uniqKey="Li P" first="Peter" last="Li">Peter Li</name><affiliation wicri:level="4"><nlm:affiliation>Oregon Health & Science University, Portland, OR.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Oregon</region><settlement type="city">Portland</settlement></placeName><wicri:cityArea>Oregon Health & Science University, Portland</wicri:cityArea><orgName type="university">Université des sciences et de la médecine de l'Oregon</orgName></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>Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.</nlm:affiliation><orgName type="university">Université du Manitoba</orgName><country>Canada</country><placeName><settlement type="city">Winnipeg</settlement><region type="state">Manitoba</region></placeName></affiliation></author><author><name sortKey="Balko, Justin M" sort="Balko, Justin M" uniqKey="Balko J" first="Justin M" last="Balko">Justin M. Balko</name><affiliation wicri:level="2"><nlm:affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Vanderbilt University Medical Center, Nashville</wicri:cityArea></affiliation></author><author><name sortKey="Dunlop, Stephen J" sort="Dunlop, Stephen J" uniqKey="Dunlop S" first="Stephen J" last="Dunlop">Stephen J. Dunlop</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:affiliation>Hennepin Healthcare, Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Hennepin Healthcare, Minneapolis</wicri:cityArea></affiliation></author><author><name sortKey="Hullsiek, Katherine H" sort="Hullsiek, Katherine H" uniqKey="Hullsiek K" first="Katherine H" last="Hullsiek">Katherine H. Hullsiek</name><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation></author><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.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>University of Minnesota, Minneapolis</wicri:cityArea></affiliation></author></analytic><series><title level="j">medRxiv : the preprint server for health sciences</title><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>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS CoV-2 in healthcare workers at high-risk of exposure.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18) and for twice weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">32995820</PMID><DateRevised><Year>2021</Year><Month>01</Month><Day>10</Day></DateRevised><Article PubModel="Electronic"><Journal><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Sep</Month><Day>18</Day></PubDate></JournalIssue><Title>medRxiv : the preprint server for health sciences</Title><ISOAbbreviation>medRxiv</ISOAbbreviation></Journal><ArticleTitle>Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">2020.09.18.20197327</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1101/2020.09.18.20197327</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS CoV-2 in healthcare workers at high-risk of exposure.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18) and for twice weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rajasingham</LastName><ForeName>Radha</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bangdiwala</LastName><ForeName>Ananta S</ForeName><Initials>AS</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nicol</LastName><ForeName>Melanie R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Skipper</LastName><ForeName>Caleb P</ForeName><Initials>CP</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pastick</LastName><ForeName>Katelyn A</ForeName><Initials>KA</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Axelrod</LastName><ForeName>Margaret L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pullen</LastName><ForeName>Matthew F</ForeName><Initials>MF</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nascene</LastName><ForeName>Alanna A</ForeName><Initials>AA</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Williams</LastName><ForeName>Darlisha A</ForeName><Initials>DA</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Engen</LastName><ForeName>Nicole W</ForeName><Initials>NW</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Okafor</LastName><ForeName>Elizabeth C</ForeName><Initials>EC</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rini</LastName><ForeName>Brian I</ForeName><Initials>BI</Initials><AffiliationInfo><Affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mayer</LastName><ForeName>Ingrid A</ForeName><Initials>IA</Initials><AffiliationInfo><Affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</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 and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.</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 and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Oregon Health & Science University, Portland, OR.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>MacKenzie</LastName><ForeName>Lauren J</ForeName><Initials>LJ</Initials><AffiliationInfo><Affiliation>Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Balko</LastName><ForeName>Justin M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Vanderbilt University Medical Center, Nashville, Tennessee.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dunlop</LastName><ForeName>Stephen J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Hennepin Healthcare, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hullsiek</LastName><ForeName>Katherine H</ForeName><Initials>KH</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boulware</LastName><ForeName>David R</ForeName><Initials>DR</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lofgren</LastName><ForeName>Sarah M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>R01 NS110519</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>F30 CA236157</GrantID><Acronym>CA</Acronym><Agency>NCI 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>T32 AI055433</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>D43 TW009345</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="D000076942">Preprint</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>18</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>medRxiv</MedlineTA><NlmUniqueID>101767986</NlmUniqueID></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="UpdateIn"><RefSource>Clin Infect Dis. 2020 Oct 17;:</RefSource><PMID Version="1">33068425</PMID></CommentsCorrections></CommentsCorrectionsList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>9</Month><Day>30</Day><Hour>6</Hour><Minute>16</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>10</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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name="États-Unis"><region name="Minnesota"><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name></region><name sortKey="Axelrod, Margaret L" sort="Axelrod, Margaret L" uniqKey="Axelrod M" first="Margaret L" last="Axelrod">Margaret L. Axelrod</name><name sortKey="Balko, Justin M" sort="Balko, Justin M" uniqKey="Balko J" first="Justin M" last="Balko">Justin M. Balko</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="Dunlop, Stephen J" sort="Dunlop, Stephen J" uniqKey="Dunlop S" first="Stephen J" last="Dunlop">Stephen J. Dunlop</name><name sortKey="Dunlop, Stephen J" sort="Dunlop, Stephen J" uniqKey="Dunlop S" first="Stephen J" last="Dunlop">Stephen J. Dunlop</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, Katherine H" sort="Hullsiek, Katherine H" uniqKey="Hullsiek K" first="Katherine H" last="Hullsiek">Katherine H. Hullsiek</name><name sortKey="Li, Peter" sort="Li, Peter" uniqKey="Li P" first="Peter" last="Li">Peter Li</name><name sortKey="Lofgren, Sarah M" sort="Lofgren, Sarah M" uniqKey="Lofgren S" first="Sarah M" last="Lofgren">Sarah M. Lofgren</name><name sortKey="Mayer, Ingrid A" sort="Mayer, Ingrid A" uniqKey="Mayer I" first="Ingrid A" last="Mayer">Ingrid A. Mayer</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="Rini, Brian I" sort="Rini, Brian I" uniqKey="Rini B" first="Brian I" last="Rini">Brian I. Rini</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="Québec"><name sortKey="Mcdonald, Emily G" sort="Mcdonald, Emily G" uniqKey="Mcdonald E" first="Emily G" last="Mcdonald">Emily G. Mcdonald</name></region><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. 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