The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial.
Identifieur interne : 000B55 ( Main/Exploration ); précédent : 000B54; suivant : 000B56The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial.
Auteurs : Justin T. Denholm [Australie] ; Joshua Davis [Australie] ; David Paterson [Australie] ; Jason Roberts [Australie, France] ; Susan Morpeth [Nouvelle-Zélande] ; Thomas Snelling [Australie] ; Dominica Zentner [Australie] ; Megan Rees [Australie] ; Matthew O'Sullivan [Australie] ; David Price [Australie] ; Asha Bowen [Australie] ; Steven Y C. Tong [Australie]Source :
- Trials [ 1745-6215 ] ; 2020.
Descripteurs français
- KwdFr :
- Association de médicaments (MeSH), Betacoronavirus (MeSH), Essais contrôlés randomisés comme sujet (MeSH), Hospitalisation (MeSH), Humains (MeSH), Hydroxychloroquine (administration et posologie), Infections à coronavirus (traitement médicamenteux), Lopinavir (administration et posologie), Norme de soins (MeSH), Pandémies (MeSH), Pneumopathie virale (traitement médicamenteux), Ritonavir (administration et posologie).
- MESH :
- administration et posologie : Hydroxychloroquine, Lopinavir, Ritonavir.
- traitement médicamenteux : Infections à coronavirus, Pneumopathie virale.
- Association de médicaments, Betacoronavirus, Essais contrôlés randomisés comme sujet, Hospitalisation, Humains, Norme de soins, Pandémies.
English descriptors
- KwdEn :
- Betacoronavirus (MeSH), COVID-19 (MeSH), Coronavirus Infections (drug therapy), Drug Therapy, Combination (MeSH), Hospitalization (MeSH), Humans (MeSH), Hydroxychloroquine (administration & dosage), Lopinavir (administration & dosage), Pandemics (MeSH), Pneumonia, Viral (drug therapy), Randomized Controlled Trials as Topic (MeSH), Ritonavir (administration & dosage), SARS-CoV-2 (MeSH), Standard of Care (MeSH).
- MESH :
- chemical , administration & dosage : Hydroxychloroquine, Lopinavir, Ritonavir.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- Betacoronavirus, COVID-19, Drug Therapy, Combination, Hospitalization, Humans, Pandemics, Randomized Controlled Trials as Topic, SARS-CoV-2, Standard of Care.
Abstract
OBJECTIVES
To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.
TRIAL DESIGN
ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management.
PARTICIPANTS
Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently.
INTERVENTION AND COMPARATOR
Participants will be randomised 1:1:1:1 to: Group 1: standard of care; Group 2: lopinavir (400mg) / ritonavir (100mg) twice daily for 10 days in tablet form; Group 3: hydroxychloroquine (800mg) 4x200mg administered 12 hours apart on Day 1, followed by 400mg twice a day for 6 days; Group 4: lopinavir /ritonavir plus hydroxychloroquine.
MAIN OUTCOMES
Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation) at 15 days after enrolment. A range of clinical and virological secondary outcomes will also be evaluated.
RANDOMISATION
The randomisation schedule will be generated by an independent statistician. Randomisation will be stratified by site and will be in permuted blocks of variable block size. The randomised sequence allocation will only be accessible to the data management group, and site investigators will have individual participant allocation provided through a web-based trial enrolment platform.
BLINDING (MASKING)
This is an open-label study, with researchers assessing the laboratory outcomes blinded to treatment allocation. No unblinding procedures relating to potential adverse effects are therefore required.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
We assumed that 5% of participants receiving standard of care would meet the primary outcome, aimed to evaluate whether interventions could lead to a relative risk of 0.5, assuming no interaction between intervention arms. This corresponds to a required sample size of 610 per arm, with a 5% two-sided significance level (alpha) and 80% power. The total sample size therefore is planned to be 2440.
TRIAL STATUS
ASCOT protocol version 3, May 5, 2020. Recruitment opened April 4, 2020 and is ongoing, with planned completion of enrolment July 31, 2021.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry ( ACTRN12620000445976 ). Prospectively registered April 6, 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
DOI: 10.1186/s13063-020-04576-9
PubMed: 32665040
PubMed Central: PMC7359440
Affiliations:
- Australie, France, Nouvelle-Zélande
- Languedoc-Roussillon, Nouvelle-Galles du Sud, Occitanie (région administrative), Victoria (État)
- Melbourne, Nîmes, Sydney
- Université de Melbourne, Université de Sydney
Links toward previous steps (curation, corpus...)
Le document en format XML
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wicri:level="4"><nlm:affiliation>Department of Cardiology, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Cardiology, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Rees, Megan" sort="Rees, Megan" uniqKey="Rees M" first="Megan" last="Rees">Megan Rees</name><affiliation wicri:level="4"><nlm:affiliation>Department of Respiratory Medicine, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of 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Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>University of Sydney, Sydney, New South Wales</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Price, David" sort="Price, David" uniqKey="Price D" first="David" last="Price">David Price</name><affiliation wicri:level="4"><nlm:affiliation>Centre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, The University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, The University of Melbourne, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:affiliation>Victorian Infectious Diseases Reference Laboratory Epidemiology Unit at the Peter Doherty Institute for Infection & Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Victorian Infectious Diseases Reference Laboratory Epidemiology Unit at the Peter Doherty Institute for Infection & Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Bowen, Asha" sort="Bowen, Asha" uniqKey="Bowen A" first="Asha" last="Bowen">Asha Bowen</name><affiliation wicri:level="1"><nlm:affiliation>Telehealth Kids Institute, Perth, West Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Telehealth Kids Institute, Perth, West Australia</wicri:regionArea><wicri:noRegion>West Australia</wicri:noRegion></affiliation></author><author><name sortKey="Tong, Steven Y C" sort="Tong, Steven Y C" uniqKey="Tong S" first="Steven Y C" last="Tong">Steven Y C. Tong</name><affiliation wicri:level="4"><nlm:affiliation>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Menzies School of Health Research, Charles Darwin University, Darwin, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Menzies School of Health Research, Charles Darwin University, Darwin</wicri:regionArea><wicri:noRegion>Darwin</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32665040</idno><idno type="pmid">32665040</idno><idno type="doi">10.1186/s13063-020-04576-9</idno><idno type="pmc">PMC7359440</idno><idno type="wicri:Area/Main/Corpus">001148</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001148</idno><idno type="wicri:Area/Main/Curation">001148</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">001148</idno><idno type="wicri:Area/Main/Exploration">001148</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial.</title><author><name sortKey="Denholm, Justin T" sort="Denholm, Justin T" uniqKey="Denholm J" first="Justin T" last="Denholm">Justin T. Denholm</name><affiliation wicri:level="4"><nlm:affiliation>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia. justin.denholm@mh.org.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Davis, Joshua" sort="Davis, Joshua" uniqKey="Davis J" first="Joshua" last="Davis">Joshua Davis</name><affiliation wicri:level="1"><nlm:affiliation>Menzies School of Health Research, Charles Darwin University, Darwin, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Menzies School of Health Research, Charles Darwin University, Darwin</wicri:regionArea><wicri:noRegion>Darwin</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Department of Infectious Diseases, John Hunter Hospital, Newcastle, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Infectious Diseases, John Hunter Hospital, Newcastle, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Paterson, David" sort="Paterson, David" uniqKey="Paterson D" first="David" last="Paterson">David Paterson</name><affiliation wicri:level="1"><nlm:affiliation>University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Department of Infectious Diseases, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Infectious Diseases, Royal Brisbane and Women's Hospital, Brisbane, Queensland</wicri:regionArea><wicri:noRegion>Queensland</wicri:noRegion></affiliation></author><author><name sortKey="Roberts, Jason" sort="Roberts, Jason" uniqKey="Roberts J" first="Jason" last="Roberts">Jason Roberts</name><affiliation wicri:level="1"><nlm:affiliation>University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:affiliation>Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:affiliation>Division of Anaesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier, Nîmes, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Division of Anaesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier, Nîmes</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Nîmes</settlement></placeName></affiliation></author><author><name sortKey="Morpeth, Susan" sort="Morpeth, Susan" uniqKey="Morpeth S" first="Susan" last="Morpeth">Susan Morpeth</name><affiliation wicri:level="1"><nlm:affiliation>Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.</nlm:affiliation><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>Middlemore Hospital, Counties Manukau District Health Board, Auckland</wicri:regionArea><wicri:noRegion>Auckland</wicri:noRegion></affiliation></author><author><name sortKey="Snelling, Thomas" sort="Snelling, Thomas" uniqKey="Snelling T" first="Thomas" last="Snelling">Thomas Snelling</name><affiliation wicri:level="4"><nlm:affiliation>School of Public Health, University of Sydney, Sydney, New South Wales, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>School of Public Health, University of Sydney, Sydney, New South Wales</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Zentner, Dominica" sort="Zentner, Dominica" uniqKey="Zentner D" first="Dominica" last="Zentner">Dominica Zentner</name><affiliation wicri:level="4"><nlm:affiliation>Department of Cardiology, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Cardiology, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Rees, Megan" sort="Rees, Megan" uniqKey="Rees M" first="Megan" last="Rees">Megan Rees</name><affiliation wicri:level="4"><nlm:affiliation>Department of Respiratory Medicine, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Respiratory Medicine, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="O Sullivan, Matthew" sort="O Sullivan, Matthew" uniqKey="O Sullivan M" first="Matthew" last="O'Sullivan">Matthew O'Sullivan</name><affiliation wicri:level="1"><nlm:affiliation>Centre for Infectious Diseases and Microbiology, Westmead Hospital, Westmead, New South Wales, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Infectious Diseases and Microbiology, Westmead Hospital, Westmead, New South Wales</wicri:regionArea><wicri:noRegion>New South Wales</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:affiliation>University of Sydney, Sydney, New South Wales, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>University of Sydney, Sydney, New South Wales</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Price, David" sort="Price, David" uniqKey="Price D" first="David" last="Price">David Price</name><affiliation wicri:level="4"><nlm:affiliation>Centre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, The University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, The University of Melbourne, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="4"><nlm:affiliation>Victorian Infectious Diseases Reference Laboratory Epidemiology Unit at the Peter Doherty Institute for Infection & Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Victorian Infectious Diseases Reference Laboratory Epidemiology Unit at the Peter Doherty Institute for Infection & Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Bowen, Asha" sort="Bowen, Asha" uniqKey="Bowen A" first="Asha" last="Bowen">Asha Bowen</name><affiliation wicri:level="1"><nlm:affiliation>Telehealth Kids Institute, Perth, West Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Telehealth Kids Institute, Perth, West Australia</wicri:regionArea><wicri:noRegion>West Australia</wicri:noRegion></affiliation></author><author><name sortKey="Tong, Steven Y C" sort="Tong, Steven Y C" uniqKey="Tong S" first="Steven Y C" last="Tong">Steven Y C. Tong</name><affiliation wicri:level="4"><nlm:affiliation>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Menzies School of Health Research, Charles Darwin University, Darwin, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Menzies School of Health Research, Charles Darwin University, Darwin</wicri:regionArea><wicri:noRegion>Darwin</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Betacoronavirus (MeSH)</term><term>COVID-19 (MeSH)</term><term>Coronavirus Infections (drug therapy)</term><term>Drug Therapy, Combination (MeSH)</term><term>Hospitalization (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (administration & dosage)</term><term>Lopinavir (administration & dosage)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (drug therapy)</term><term>Randomized Controlled Trials as Topic (MeSH)</term><term>Ritonavir (administration & dosage)</term><term>SARS-CoV-2 (MeSH)</term><term>Standard of Care (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Association de médicaments (MeSH)</term><term>Betacoronavirus (MeSH)</term><term>Essais contrôlés randomisés comme sujet (MeSH)</term><term>Hospitalisation (MeSH)</term><term>Humains (MeSH)</term><term>Hydroxychloroquine (administration et posologie)</term><term>Infections à coronavirus (traitement médicamenteux)</term><term>Lopinavir (administration et posologie)</term><term>Norme de soins (MeSH)</term><term>Pandémies (MeSH)</term><term>Pneumopathie virale (traitement médicamenteux)</term><term>Ritonavir (administration et posologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Betacoronavirus</term><term>COVID-19</term><term>Drug Therapy, Combination</term><term>Hospitalization</term><term>Humans</term><term>Pandemics</term><term>Randomized Controlled Trials as Topic</term><term>SARS-CoV-2</term><term>Standard of Care</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Association de médicaments</term><term>Betacoronavirus</term><term>Essais contrôlés randomisés comme sujet</term><term>Hospitalisation</term><term>Humains</term><term>Norme de soins</term><term>Pandémies</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL DESIGN</b></p><p>ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management.</p></div><div type="abstract" xml:lang="en"><p><b>PARTICIPANTS</b></p><p>Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently.</p></div><div type="abstract" xml:lang="en"><p><b>INTERVENTION AND COMPARATOR</b></p><p>Participants will be randomised 1:1:1:1 to: Group 1: standard of care; Group 2: lopinavir (400mg) / ritonavir (100mg) twice daily for 10 days in tablet form; Group 3: hydroxychloroquine (800mg) 4x200mg administered 12 hours apart on Day 1, followed by 400mg twice a day for 6 days; Group 4: lopinavir /ritonavir plus hydroxychloroquine.</p></div><div type="abstract" xml:lang="en"><p><b>MAIN OUTCOMES</b></p><p>Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation) at 15 days after enrolment. A range of clinical and virological secondary outcomes will also be evaluated.</p></div><div type="abstract" xml:lang="en"><p><b>RANDOMISATION</b></p><p>The randomisation schedule will be generated by an independent statistician. Randomisation will be stratified by site and will be in permuted blocks of variable block size. The randomised sequence allocation will only be accessible to the data management group, and site investigators will have individual participant allocation provided through a web-based trial enrolment platform.</p></div><div type="abstract" xml:lang="en"><p><b>BLINDING (MASKING)</b></p><p>This is an open-label study, with researchers assessing the laboratory outcomes blinded to treatment allocation. No unblinding procedures relating to potential adverse effects are therefore required.</p></div><div type="abstract" xml:lang="en"><p><b>NUMBERS TO BE RANDOMISED (SAMPLE SIZE)</b></p><p>We assumed that 5% of participants receiving standard of care would meet the primary outcome, aimed to evaluate whether interventions could lead to a relative risk of 0.5, assuming no interaction between intervention arms. This corresponds to a required sample size of 610 per arm, with a 5% two-sided significance level (alpha) and 80% power. The total sample size therefore is planned to be 2440.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL STATUS</b></p><p>ASCOT protocol version 3, May 5, 2020. Recruitment opened April 4, 2020 and is ongoing, with planned completion of enrolment July 31, 2021.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>Australian New Zealand Clinical Trials Registry ( ACTRN12620000445976 ). Prospectively registered April 6, 2020.</p></div><div type="abstract" xml:lang="en"><p><b>FULL PROTOCOL</b></p><p>The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32665040</PMID><DateCompleted><Year>2020</Year><Month>08</Month><Day>18</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>21</Volume><Issue>1</Issue><PubDate><Year>2020</Year><Month>Jul</Month><Day>14</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial.</ArticleTitle><Pagination><MedlinePgn>646</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-020-04576-9</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.</AbstractText><AbstractText Label="TRIAL DESIGN" NlmCategory="METHODS">ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management.</AbstractText><AbstractText Label="PARTICIPANTS" NlmCategory="METHODS">Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently.</AbstractText><AbstractText Label="INTERVENTION AND COMPARATOR" NlmCategory="UNASSIGNED">Participants will be randomised 1:1:1:1 to: Group 1: standard of care; Group 2: lopinavir (400mg) / ritonavir (100mg) twice daily for 10 days in tablet form; Group 3: hydroxychloroquine (800mg) 4x200mg administered 12 hours apart on Day 1, followed by 400mg twice a day for 6 days; Group 4: lopinavir /ritonavir plus hydroxychloroquine.</AbstractText><AbstractText Label="MAIN OUTCOMES" NlmCategory="RESULTS">Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation) at 15 days after enrolment. A range of clinical and virological secondary outcomes will also be evaluated.</AbstractText><AbstractText Label="RANDOMISATION" NlmCategory="UNASSIGNED">The randomisation schedule will be generated by an independent statistician. Randomisation will be stratified by site and will be in permuted blocks of variable block size. The randomised sequence allocation will only be accessible to the data management group, and site investigators will have individual participant allocation provided through a web-based trial enrolment platform.</AbstractText><AbstractText Label="BLINDING (MASKING)" NlmCategory="UNASSIGNED">This is an open-label study, with researchers assessing the laboratory outcomes blinded to treatment allocation. No unblinding procedures relating to potential adverse effects are therefore required.</AbstractText><AbstractText Label="NUMBERS TO BE RANDOMISED (SAMPLE SIZE)" NlmCategory="UNASSIGNED">We assumed that 5% of participants receiving standard of care would meet the primary outcome, aimed to evaluate whether interventions could lead to a relative risk of 0.5, assuming no interaction between intervention arms. This corresponds to a required sample size of 610 per arm, with a 5% two-sided significance level (alpha) and 80% power. The total sample size therefore is planned to be 2440.</AbstractText><AbstractText Label="TRIAL STATUS" NlmCategory="UNASSIGNED">ASCOT protocol version 3, May 5, 2020. Recruitment opened April 4, 2020 and is ongoing, with planned completion of enrolment July 31, 2021.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Australian New Zealand Clinical Trials Registry ( ACTRN12620000445976 ). Prospectively registered April 6, 2020.</AbstractText><AbstractText Label="FULL PROTOCOL" NlmCategory="UNASSIGNED">The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Denholm</LastName><ForeName>Justin T</ForeName><Initials>JT</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-9214-6431</Identifier><AffiliationInfo><Affiliation>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia. justin.denholm@mh.org.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Davis</LastName><ForeName>Joshua</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Menzies School of Health Research, Charles Darwin University, Darwin, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Infectious Diseases, John Hunter Hospital, Newcastle, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paterson</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Infectious Diseases, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Roberts</LastName><ForeName>Jason</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Division of Anaesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier, Nîmes, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morpeth</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Snelling</LastName><ForeName>Thomas</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>School of Public Health, University of Sydney, Sydney, New South Wales, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zentner</LastName><ForeName>Dominica</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Cardiology, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rees</LastName><ForeName>Megan</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>O'Sullivan</LastName><ForeName>Matthew</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Centre for Infectious Diseases and Microbiology, Westmead Hospital, Westmead, New South Wales, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>University of Sydney, Sydney, New South Wales, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Price</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Centre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, The University of Melbourne, Melbourne, Victoria, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Victorian Infectious Diseases Reference Laboratory Epidemiology Unit at the Peter Doherty Institute for Infection & Immunity, Royal Melbourne Hospital and The University of Melbourne, Melbourne, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bowen</LastName><ForeName>Asha</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Telehealth Kids Institute, Perth, West Australia, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tong</LastName><ForeName>Steven Y C</ForeName><Initials>SYC</Initials><AffiliationInfo><Affiliation>Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Menzies School of Health Research, Charles Darwin University, Darwin, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>ASCOT Investigator Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D000078325">Clinical Trial Protocol</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016422">Letter</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>2494G1JF75</RegistryNumber><NameOfSubstance UI="D061466">Lopinavir</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical><Chemical><RegistryNumber>O3J8G9O825</RegistryNumber><NameOfSubstance UI="D019438">Ritonavir</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="Y">Betacoronavirus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006760" MajorTopicYN="N">Hospitalization</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061466" MajorTopicYN="N">Lopinavir</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="Y">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019438" MajorTopicYN="N">Ritonavir</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059039" MajorTopicYN="Y">Standard of Care</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Randomised controlled trial</Keyword><Keyword MajorTopicYN="N">hydroxychloroquine</Keyword><Keyword MajorTopicYN="N">lopinavir</Keyword><Keyword MajorTopicYN="N">protocol</Keyword><Keyword MajorTopicYN="N">ritonavir</Keyword></KeywordList><InvestigatorList><Investigator ValidYN="Y"><LastName>Davis</LastName><ForeName>Joshua</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Denholm</LastName><ForeName>Justin</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Tong</LastName><ForeName>Steven</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Rees</LastName><ForeName>Megan</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Paterson</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Price</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Morpeth</LastName><ForeName>Susan</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>O'Sullivan</LastName><ForeName>Matthew</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Roberts</LastName><ForeName>Jason</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Snelling</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Anderson</LastName><ForeName>Sue</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>McQuilton</LastName><ForeName>Zoe</ForeName><Initials>Z</Initials></Investigator><Investigator ValidYN="Y"><LastName>Venkatesh</LastName><ForeName>Bala</ForeName><Initials>B</Initials></Investigator><Investigator ValidYN="Y"><LastName>Hammond</LastName><ForeName>Naomi</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Jha</LastName><ForeName>Vivekanend</ForeName><Initials>V</Initials></Investigator><Investigator ValidYN="Y"><LastName>Burston</LastName><ForeName>Victoria John</ForeName><Initials>VJ</Initials></Investigator><Investigator ValidYN="Y"><LastName>McMahon</LastName><ForeName>James</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Charles</LastName><ForeName>Patrick</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Commons</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>O'Brien</LastName><ForeName>Daniel</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mahoney</LastName><ForeName>Andrew</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Sheffield</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lim</LastName><ForeName>Lyn-Li</ForeName><Initials>LL</Initials></Investigator><Investigator ValidYN="Y"><LastName>Gardiner</LastName><ForeName>Brad</ForeName><Initials>B</Initials></Investigator><Investigator ValidYN="Y"><LastName>Schulz</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Torresi</LastName><ForeName>Joseph</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chean</LastName><ForeName>Roy</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Sasadeusz</LastName><ForeName>Joseph</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Rogers</LastName><ForeName>Ben</ForeName><Initials>B</Initials></Investigator><Investigator ValidYN="Y"><LastName>Aboltins</LastName><ForeName>Craig</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Singh</LastName><ForeName>Kasha</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Yong</LastName><ForeName>Michelle</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lister</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Visvanathan</LastName><ForeName>Kumar</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Molton</LastName><ForeName>James</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Tai</LastName><ForeName>Alex</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chalmers</LastName><ForeName>Rachel</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Martinello</LastName><ForeName>Marianne</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Wilson</LastName><ForeName>Paul</ForeName><Initials>P</Initials></Investigator><Investigator 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Tong</name><name sortKey="Tong, Steven Y C" sort="Tong, Steven Y C" uniqKey="Tong S" first="Steven Y C" last="Tong">Steven Y C. Tong</name><name sortKey="Zentner, Dominica" sort="Zentner, Dominica" uniqKey="Zentner D" first="Dominica" last="Zentner">Dominica Zentner</name></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Roberts, Jason" sort="Roberts, Jason" uniqKey="Roberts J" first="Jason" last="Roberts">Jason Roberts</name></region></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Morpeth, Susan" sort="Morpeth, Susan" uniqKey="Morpeth S" first="Susan" last="Morpeth">Susan Morpeth</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|wiki= Sante
|area= CovidChloroV1
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|clé= pubmed:32665040
|texte= The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial.
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