Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19.
Identifieur interne : 000D73 ( Main/Exploration ); précédent : 000D72; suivant : 000D74Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19.
Auteurs : Ali S. Omrani [Qatar] ; Sameer A. Pathan [Qatar, Royaume-Uni, Australie] ; Sarah A. Thomas [Royaume-Uni] ; Tim R E. Harris [Qatar, Royaume-Uni] ; Peter V. Coyle ; Caroline E. Thomas [Qatar] ; Isma Qureshi [Qatar] ; Zain A. Bhutta [Qatar] ; Naema Al Mawlawi ; Reham Al Kahlout ; Ashraf Elmalik [Qatar] ; Aftab M. Azad [Qatar] ; Joanne Daghfal [Qatar] ; Mulham Mustafa [Qatar] ; Andrew Jeremijenko [Qatar] ; Hussam Al Soub [Qatar] ; Mohammed Abu Khattab [Qatar] ; Muna Al Maslamani [Qatar] ; Stephen H. Thomas [Qatar, Royaume-Uni]Source :
- EClinicalMedicine [ 2589-5370 ] ; 2020.
Abstract
Background
Hydroxychloroquine (HC) ± azithromycin (AZ) is widely used for Covid-19. The Qatar Prospective RCT of Expediting Coronavirus Tapering (Q-PROTECT) aimed to assess virologic cure rates of HC±AZ in cases of low-acuity Covid-19.
Methods
Q-PROTECT employed a prospective, placebo-controlled design with blinded randomization to three parallel arms: placebo, oral HC (600 mg daily for one week), or oral HC plus oral AZ (500 mg day one, 250 mg daily on days two through five). At enrollment, non-hospitalized participants had mild or no symptoms and were within a day of Covid-19 positivity by polymerase chain reaction (PCR). After six days, intent-to-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% confidence intervals (CIs) and χ
Findings
The study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3·9%), 7 (4·6%), and 9 (5·9%) participants go off study medications before completing the medication course (
Interpretation
HC±AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19.
Funding
The study was supported by internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar).
DOI: 10.1016/j.eclinm.2020.100645
PubMed: 33251500
PubMed Central: PMC7678437
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Harris</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London</wicri:regionArea><wicri:noRegion>Queen Mary Univ. of London</wicri:noRegion></affiliation></author><author><name sortKey="Coyle, Peter V" sort="Coyle, Peter V" uniqKey="Coyle P" first="Peter V" last="Coyle">Peter V. Coyle</name><affiliation><nlm:affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</nlm:affiliation><wicri:noCountry code="subField">Doha</wicri:noCountry></affiliation></author><author><name sortKey="Thomas, Caroline E" sort="Thomas, Caroline E" uniqKey="Thomas C" first="Caroline E" last="Thomas">Caroline E. Thomas</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Qureshi, Isma" sort="Qureshi, Isma" uniqKey="Qureshi I" first="Isma" last="Qureshi">Isma Qureshi</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Bhutta, Zain A" sort="Bhutta, Zain A" uniqKey="Bhutta Z" first="Zain A" last="Bhutta">Zain A. Bhutta</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Mawlawi, Naema Al" sort="Mawlawi, Naema Al" uniqKey="Mawlawi N" first="Naema Al" last="Mawlawi">Naema Al Mawlawi</name><affiliation><nlm:affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</nlm:affiliation><wicri:noCountry code="subField">Doha</wicri:noCountry></affiliation></author><author><name sortKey="Kahlout, Reham Al" sort="Kahlout, Reham Al" uniqKey="Kahlout R" first="Reham Al" last="Kahlout">Reham Al Kahlout</name><affiliation><nlm:affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</nlm:affiliation><wicri:noCountry code="subField">Doha</wicri:noCountry></affiliation></author><author><name sortKey="Elmalik, Ashraf" sort="Elmalik, Ashraf" uniqKey="Elmalik A" first="Ashraf" last="Elmalik">Ashraf Elmalik</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacy, Hamad General Hospital, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Pharmacy, Hamad General Hospital, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Azad, Aftab M" sort="Azad, Aftab M" uniqKey="Azad A" first="Aftab M" last="Azad">Aftab M. Azad</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Daghfal, Joanne" sort="Daghfal, Joanne" uniqKey="Daghfal J" first="Joanne" last="Daghfal">Joanne Daghfal</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Mustafa, Mulham" sort="Mustafa, Mulham" uniqKey="Mustafa M" first="Mulham" last="Mustafa">Mulham Mustafa</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Jeremijenko, Andrew" sort="Jeremijenko, Andrew" uniqKey="Jeremijenko A" first="Andrew" last="Jeremijenko">Andrew Jeremijenko</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Soub, Hussam Al" sort="Soub, Hussam Al" uniqKey="Soub H" first="Hussam Al" last="Soub">Hussam Al Soub</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Khattab, Mohammed Abu" sort="Khattab, Mohammed Abu" uniqKey="Khattab M" first="Mohammed Abu" last="Khattab">Mohammed Abu Khattab</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Maslamani, Muna Al" sort="Maslamani, Muna Al" uniqKey="Maslamani M" first="Muna Al" last="Maslamani">Muna Al Maslamani</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Weill Cornell Medical College in Qatar, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Weill Cornell Medical College in Qatar, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Thomas, Stephen H" sort="Thomas, Stephen H" uniqKey="Thomas S" first="Stephen H" last="Thomas">Stephen H. Thomas</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London</wicri:regionArea><wicri:noRegion>Queen Mary Univ. of London</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33251500</idno><idno type="pmid">33251500</idno><idno type="doi">10.1016/j.eclinm.2020.100645</idno><idno type="pmc">PMC7678437</idno><idno type="wicri:Area/Main/Corpus">000753</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000753</idno><idno type="wicri:Area/Main/Curation">000753</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000753</idno><idno type="wicri:Area/Main/Exploration">000753</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19.</title><author><name sortKey="Omrani, Ali S" sort="Omrani, Ali S" uniqKey="Omrani A" first="Ali S" last="Omrani">Ali S. Omrani</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Pathan, Sameer A" sort="Pathan, Sameer A" uniqKey="Pathan S" first="Sameer A" last="Pathan">Sameer A. Pathan</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London</wicri:regionArea><wicri:noRegion>Queen Mary Univ. of London</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:affiliation>School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>School of Public Health and Preventive Medicine, Monash University, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Thomas, Sarah A" sort="Thomas, Sarah A" uniqKey="Thomas S" first="Sarah A" last="Thomas">Sarah A. Thomas</name><affiliation wicri:level="1"><nlm:affiliation>BSc Candidate in Medical Biosciences, Faculty of Medicine, Imperial College London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>BSc Candidate in Medical Biosciences, Faculty of Medicine, Imperial College London</wicri:regionArea><wicri:noRegion>Imperial College London</wicri:noRegion></affiliation></author><author><name sortKey="Harris, Tim R E" sort="Harris, Tim R E" uniqKey="Harris T" first="Tim R E" last="Harris">Tim R E. Harris</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London</wicri:regionArea><wicri:noRegion>Queen Mary Univ. of London</wicri:noRegion></affiliation></author><author><name sortKey="Coyle, Peter V" sort="Coyle, Peter V" uniqKey="Coyle P" first="Peter V" last="Coyle">Peter V. Coyle</name><affiliation><nlm:affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</nlm:affiliation><wicri:noCountry code="subField">Doha</wicri:noCountry></affiliation></author><author><name sortKey="Thomas, Caroline E" sort="Thomas, Caroline E" uniqKey="Thomas C" first="Caroline E" last="Thomas">Caroline E. Thomas</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Qureshi, Isma" sort="Qureshi, Isma" uniqKey="Qureshi I" first="Isma" last="Qureshi">Isma Qureshi</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Bhutta, Zain A" sort="Bhutta, Zain A" uniqKey="Bhutta Z" first="Zain A" last="Bhutta">Zain A. Bhutta</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Mawlawi, Naema Al" sort="Mawlawi, Naema Al" uniqKey="Mawlawi N" first="Naema Al" last="Mawlawi">Naema Al Mawlawi</name><affiliation><nlm:affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</nlm:affiliation><wicri:noCountry code="subField">Doha</wicri:noCountry></affiliation></author><author><name sortKey="Kahlout, Reham Al" sort="Kahlout, Reham Al" uniqKey="Kahlout R" first="Reham Al" last="Kahlout">Reham Al Kahlout</name><affiliation><nlm:affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</nlm:affiliation><wicri:noCountry code="subField">Doha</wicri:noCountry></affiliation></author><author><name sortKey="Elmalik, Ashraf" sort="Elmalik, Ashraf" uniqKey="Elmalik A" first="Ashraf" last="Elmalik">Ashraf Elmalik</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pharmacy, Hamad General Hospital, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Pharmacy, Hamad General Hospital, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Azad, Aftab M" sort="Azad, Aftab M" uniqKey="Azad A" first="Aftab M" last="Azad">Aftab M. Azad</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation></author><author><name sortKey="Daghfal, Joanne" sort="Daghfal, Joanne" uniqKey="Daghfal J" first="Joanne" last="Daghfal">Joanne Daghfal</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Mustafa, Mulham" sort="Mustafa, Mulham" uniqKey="Mustafa M" first="Mulham" last="Mustafa">Mulham Mustafa</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Jeremijenko, Andrew" sort="Jeremijenko, Andrew" uniqKey="Jeremijenko A" first="Andrew" last="Jeremijenko">Andrew Jeremijenko</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Soub, Hussam Al" sort="Soub, Hussam Al" uniqKey="Soub H" first="Hussam Al" last="Soub">Hussam Al Soub</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Khattab, Mohammed Abu" sort="Khattab, Mohammed Abu" uniqKey="Khattab M" first="Mohammed Abu" last="Khattab">Mohammed Abu Khattab</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Maslamani, Muna Al" sort="Maslamani, Muna Al" uniqKey="Maslamani M" first="Muna Al" last="Maslamani">Muna Al Maslamani</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Weill Cornell Medical College in Qatar, Doha, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Medicine, Weill Cornell Medical College in Qatar, Doha</wicri:regionArea><wicri:noRegion>Doha</wicri:noRegion></affiliation></author><author><name sortKey="Thomas, Stephen H" sort="Thomas, Stephen H" uniqKey="Thomas S" first="Stephen H" last="Thomas">Stephen H. Thomas</name><affiliation wicri:level="1"><nlm:affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</nlm:affiliation><country xml:lang="fr">Qatar</country><wicri:regionArea>Department of Emergency Medicine, Hamad General Hospital, Doha 3050</wicri:regionArea><wicri:noRegion>Doha 3050</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London</wicri:regionArea><wicri:noRegion>Queen Mary Univ. of London</wicri:noRegion></affiliation></author></analytic><series><title level="j">EClinicalMedicine</title><idno type="eISSN">2589-5370</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>Hydroxychloroquine (HC) ± azithromycin (AZ) is widely used for Covid-19. The Qatar Prospective RCT of Expediting Coronavirus Tapering (Q-PROTECT) aimed to assess virologic cure rates of HC±AZ in cases of low-acuity Covid-19.</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>Q-PROTECT employed a prospective, placebo-controlled design with blinded randomization to three parallel arms: placebo, oral HC (600 mg daily for one week), or oral HC plus oral AZ (500 mg day one, 250 mg daily on days two through five). At enrollment, non-hospitalized participants had mild or no symptoms and were within a day of Covid-19 positivity by polymerase chain reaction (PCR). After six days, intent-to-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% confidence intervals (CIs) and χ</p></div><div type="abstract" xml:lang="en"><p><b>Findings</b></p><p>The study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3·9%), 7 (4·6%), and 9 (5·9%) participants go off study medications before completing the medication course (</p></div><div type="abstract" xml:lang="en"><p><b>Interpretation</b></p><p>HC±AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19.</p></div><div type="abstract" xml:lang="en"><p><b>Funding</b></p><p>The study was supported by internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar).</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33251500</PMID><DateRevised><Year>2020</Year><Month>12</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2589-5370</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><PubDate><Year>2020</Year><Month>Dec</Month></PubDate></JournalIssue><Title>EClinicalMedicine</Title><ISOAbbreviation>EClinicalMedicine</ISOAbbreviation></Journal><ArticleTitle>Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19.</ArticleTitle><Pagination><MedlinePgn>100645</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eclinm.2020.100645</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">Hydroxychloroquine (HC) ± azithromycin (AZ) is widely used for Covid-19. The Qatar Prospective RCT of Expediting Coronavirus Tapering (Q-PROTECT) aimed to assess virologic cure rates of HC±AZ in cases of low-acuity Covid-19.</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">Q-PROTECT employed a prospective, placebo-controlled design with blinded randomization to three parallel arms: placebo, oral HC (600 mg daily for one week), or oral HC plus oral AZ (500 mg day one, 250 mg daily on days two through five). At enrollment, non-hospitalized participants had mild or no symptoms and were within a day of Covid-19 positivity by polymerase chain reaction (PCR). After six days, intent-to-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% confidence intervals (CIs) and χ<sup>2</sup> testing. (ClinicalTrials.gov NCT04349592, trial status closed to new participants.).</AbstractText><AbstractText Label="Findings" NlmCategory="UNASSIGNED">The study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3·9%), 7 (4·6%), and 9 (5·9%) participants go off study medications before completing the medication course (<i>p</i> = 0·716). Day six PCR results were available for all 152 HC+AZ participants, 149/152 (98·0%) HC participants, and 147/152 (96·7%) placebo participants. Day six ITT analysis found no difference (<i>p</i> = 0·821) in groups' proportions achieving virologic cure: HC+AZ 16/152 (10·5%), HC 19/149 (12·8%), placebo 18/147 (12·2%). Day 14 assessment also showed no association (<i>p</i> = 0·072) between study group and viral cure: HC+AZ 30/149 (20·1%,), HC 42/146 (28·8%), placebo 45/143 (31·5%). There were no serious adverse events.</AbstractText><AbstractText Label="Interpretation" NlmCategory="UNASSIGNED">HC±AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19.</AbstractText><AbstractText Label="Funding" NlmCategory="UNASSIGNED">The study was supported by internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar).</AbstractText><CopyrightInformation>© 2020 The Authors.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Omrani</LastName><ForeName>Ali S</ForeName><Initials>AS</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pathan</LastName><ForeName>Sameer A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Sarah A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>BSc Candidate in Medical Biosciences, Faculty of Medicine, Imperial College London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Harris</LastName><ForeName>Tim R E</ForeName><Initials>TRE</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coyle</LastName><ForeName>Peter V</ForeName><Initials>PV</Initials><AffiliationInfo><Affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Caroline E</ForeName><Initials>CE</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Qureshi</LastName><ForeName>Isma</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bhutta</LastName><ForeName>Zain A</ForeName><Initials>ZA</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mawlawi</LastName><ForeName>Naema Al</ForeName><Initials>NA</Initials><AffiliationInfo><Affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kahlout</LastName><ForeName>Reham Al</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elmalik</LastName><ForeName>Ashraf</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Hamad General Hospital, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Azad</LastName><ForeName>Aftab M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Daghfal</LastName><ForeName>Joanne</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mustafa</LastName><ForeName>Mulham</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jeremijenko</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Soub</LastName><ForeName>Hussam Al</ForeName><Initials>HA</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Khattab</LastName><ForeName>Mohammed Abu</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maslamani</LastName><ForeName>Muna Al</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Medicine, Weill Cornell Medical College in Qatar, Doha, Qatar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Stephen H</ForeName><Initials>SH</Initials><AffiliationInfo><Affiliation>Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Blizard Institute, Barts and The London School of Medicine, Queen Mary Univ. of London, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04349592</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>20</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>EClinicalMedicine</MedlineTA><NlmUniqueID>101733727</NlmUniqueID><ISSNLinking>2589-5370</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Azithromycin</Keyword><Keyword MajorTopicYN="N">Covid-19</Keyword><Keyword MajorTopicYN="N">Hyodroxychloroquine</Keyword></KeywordList><CoiStatement>The authors have no financial or personal relationships with other people or organizations that could represent a conflict of interest.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>09</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>10</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>10</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>11</Month><Day>30</Day><Hour>5</Hour><Minute>56</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33251500</ArticleId><ArticleId IdType="doi">10.1016/j.eclinm.2020.100645</ArticleId><ArticleId IdType="pii">S2589-5370(20)30389-8</ArticleId><ArticleId IdType="pmc">PMC7678437</ArticleId></ArticleIdList><pmc-dir>pmcsd</pmc-dir>
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Coyle</name><name sortKey="Kahlout, Reham Al" sort="Kahlout, Reham Al" uniqKey="Kahlout R" first="Reham Al" last="Kahlout">Reham Al Kahlout</name><name sortKey="Mawlawi, Naema Al" sort="Mawlawi, Naema Al" uniqKey="Mawlawi N" first="Naema Al" last="Mawlawi">Naema Al Mawlawi</name></noCountry><country name="Qatar"><noRegion><name sortKey="Omrani, Ali S" sort="Omrani, Ali S" uniqKey="Omrani A" first="Ali S" last="Omrani">Ali S. Omrani</name></noRegion><name sortKey="Azad, Aftab M" sort="Azad, Aftab M" uniqKey="Azad A" first="Aftab M" last="Azad">Aftab M. Azad</name><name sortKey="Bhutta, Zain A" sort="Bhutta, Zain A" uniqKey="Bhutta Z" first="Zain A" last="Bhutta">Zain A. Bhutta</name><name sortKey="Daghfal, Joanne" sort="Daghfal, Joanne" uniqKey="Daghfal J" first="Joanne" last="Daghfal">Joanne Daghfal</name><name sortKey="Elmalik, Ashraf" sort="Elmalik, Ashraf" uniqKey="Elmalik A" first="Ashraf" last="Elmalik">Ashraf Elmalik</name><name sortKey="Harris, Tim R E" sort="Harris, Tim R E" uniqKey="Harris T" first="Tim R E" last="Harris">Tim R E. Harris</name><name sortKey="Jeremijenko, Andrew" sort="Jeremijenko, Andrew" uniqKey="Jeremijenko A" first="Andrew" last="Jeremijenko">Andrew Jeremijenko</name><name sortKey="Khattab, Mohammed Abu" sort="Khattab, Mohammed Abu" uniqKey="Khattab M" first="Mohammed Abu" last="Khattab">Mohammed Abu Khattab</name><name sortKey="Maslamani, Muna Al" sort="Maslamani, Muna Al" uniqKey="Maslamani M" first="Muna Al" last="Maslamani">Muna Al Maslamani</name><name sortKey="Maslamani, Muna Al" sort="Maslamani, Muna Al" uniqKey="Maslamani M" first="Muna Al" last="Maslamani">Muna Al Maslamani</name><name sortKey="Mustafa, Mulham" sort="Mustafa, Mulham" uniqKey="Mustafa M" first="Mulham" last="Mustafa">Mulham Mustafa</name><name sortKey="Pathan, Sameer A" sort="Pathan, Sameer A" uniqKey="Pathan S" first="Sameer A" last="Pathan">Sameer A. Pathan</name><name sortKey="Qureshi, Isma" sort="Qureshi, Isma" uniqKey="Qureshi I" first="Isma" last="Qureshi">Isma Qureshi</name><name sortKey="Soub, Hussam Al" sort="Soub, Hussam Al" uniqKey="Soub H" first="Hussam Al" last="Soub">Hussam Al Soub</name><name sortKey="Thomas, Caroline E" sort="Thomas, Caroline E" uniqKey="Thomas C" first="Caroline E" last="Thomas">Caroline E. Thomas</name><name sortKey="Thomas, Stephen H" sort="Thomas, Stephen H" uniqKey="Thomas S" first="Stephen H" last="Thomas">Stephen H. Thomas</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Pathan, Sameer A" sort="Pathan, Sameer A" uniqKey="Pathan S" first="Sameer A" last="Pathan">Sameer A. Pathan</name></noRegion><name sortKey="Harris, Tim R E" sort="Harris, Tim R E" uniqKey="Harris T" first="Tim R E" last="Harris">Tim R E. Harris</name><name sortKey="Thomas, Sarah A" sort="Thomas, Sarah A" uniqKey="Thomas S" first="Sarah A" last="Thomas">Sarah A. Thomas</name><name sortKey="Thomas, Stephen H" sort="Thomas, Stephen H" uniqKey="Thomas S" first="Stephen H" last="Thomas">Stephen H. Thomas</name></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Pathan, Sameer A" sort="Pathan, Sameer A" uniqKey="Pathan S" first="Sameer A" last="Pathan">Sameer A. Pathan</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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