CovidChloroV1, Main, Exploration, bibRecord, 000E10

Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.

Identifieur interne : 000E10 ( Main/Exploration ); précédent : 000E09; suivant : 000E11

Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.

Auteurs : Pradeesh Sivapalan [Danemark] ; Charlotte Suppli Ulrik [Danemark] ; Therese Sophie Lappere [Danemark] ; Josefin Viktoria Eklöf [Danemark] ; Saher Burhan Shaker [Danemark] ; Uffe Christian Steinholtz B Dtger [Danemark] ; Andrea Browatzki [Danemark] ; Christian Niels Meyer [Danemark] ; Ulla M Ller Weinreich [Danemark] ; Christian B. Laursen [Danemark] ; Tor Biering-S Rensen [Danemark] ; Filip Krag Knop [Danemark] ; Jens D. Lundgren [Danemark] ; Jens-Ulrik St Hr Jensen [Danemark]

Source :

Trials [ 1745-6215 ] ; 2020.

RBID : pubmed:33081817

Descripteurs français

KwdFr :
- Analyse en intention de traitement (méthodes), Antibactériens (effets indésirables), Antibactériens (usage thérapeutique), Antibioprophylaxie (méthodes), Antipaludiques (effets indésirables), Antipaludiques (usage thérapeutique), Association de médicaments (MeSH), Azithromycine (effets indésirables), Azithromycine (usage thérapeutique), Betacoronavirus (effets des médicaments et des substances chimiques), Betacoronavirus (génétique), Comportement de réduction des risques (MeSH), Danemark (épidémiologie), Femelle (MeSH), Hospitalisation (statistiques et données numériques), Humains (MeSH), Hydroxychloroquine (effets indésirables), Hydroxychloroquine (usage thérapeutique), Infections à coronavirus (prévention et contrôle), Infections à coronavirus (transmission), Infections à coronavirus (virologie), Infections à coronavirus (épidémiologie), Mortalité hospitalière (tendances), Mâle (MeSH), Méthode en double aveugle (MeSH), Pandémies (prévention et contrôle), Placebo (administration et posologie), Pneumopathie virale (prévention et contrôle), Pneumopathie virale (transmission), Pneumopathie virale (virologie), Pneumopathie virale (épidémiologie), Sujet âgé (MeSH), Unités de soins intensifs (statistiques et données numériques), Ventilation non effractive (effets indésirables), Études cas-témoins (MeSH).
MESH :
- administration et posologie : Placebo.
- effets des médicaments et des substances chimiques : Betacoronavirus.
- effets indésirables : Antibactériens, Antipaludiques, Azithromycine, Hydroxychloroquine, Ventilation non effractive.
- génétique : Betacoronavirus.
- méthodes : Analyse en intention de traitement, Antibioprophylaxie.
- prévention et contrôle : Infections à coronavirus, Pandémies, Pneumopathie virale.
- statistiques et données numériques : Hospitalisation, Unités de soins intensifs.
- tendances : Mortalité hospitalière.
- usage thérapeutique : Antibactériens, Antipaludiques, Azithromycine, Hydroxychloroquine, Infections à coronavirus, Pneumopathie virale.
- virologie : Infections à coronavirus, Pneumopathie virale.
- épidémiologie : Danemark, Infections à coronavirus, Pneumopathie virale.
- Association de médicaments, Comportement de réduction des risques, Femelle, Humains, Mâle, Méthode en double aveugle, Sujet âgé, Études cas-témoins.
Wicri :
- geographic : Danemark.

English descriptors

KwdEn :
- Aged (MeSH), Anti-Bacterial Agents (adverse effects), Anti-Bacterial Agents (therapeutic use), Antibiotic Prophylaxis (methods), Antimalarials (adverse effects), Antimalarials (therapeutic use), Azithromycin (adverse effects), Azithromycin (therapeutic use), Betacoronavirus (drug effects), Betacoronavirus (genetics), COVID-19 (MeSH), Case-Control Studies (MeSH), Coronavirus Infections (epidemiology), Coronavirus Infections (prevention & control), Coronavirus Infections (transmission), Coronavirus Infections (virology), Denmark (epidemiology), Double-Blind Method (MeSH), Drug Therapy, Combination (MeSH), Female (MeSH), Hospital Mortality (trends), Hospitalization (statistics & numerical data), Humans (MeSH), Hydroxychloroquine (adverse effects), Hydroxychloroquine (therapeutic use), Intensive Care Units (statistics & numerical data), Intention to Treat Analysis (methods), Male (MeSH), Noninvasive Ventilation (adverse effects), Pandemics (prevention & control), Placebos (administration & dosage), Pneumonia, Viral (epidemiology), Pneumonia, Viral (prevention & control), Pneumonia, Viral (transmission), Pneumonia, Viral (virology), Risk Reduction Behavior (MeSH), SARS-CoV-2 (MeSH).
MESH :
- chemical , administration & dosage : Placebos.
- chemical , adverse effects : Anti-Bacterial Agents, Antimalarials, Azithromycin, Hydroxychloroquine.
- chemical , therapeutic use : Anti-Bacterial Agents, Antimalarials, Azithromycin, Hydroxychloroquine.
- geographic , epidemiology : Denmark.
- adverse effects : Noninvasive Ventilation.
- drug effects : Betacoronavirus.
- epidemiology : Coronavirus Infections, Pneumonia, Viral.
- genetics : Betacoronavirus.
- methods : Antibiotic Prophylaxis, Intention to Treat Analysis.
- prevention & control : Coronavirus Infections, Pandemics, Pneumonia, Viral.
- statistics & numerical data : Hospitalization, Intensive Care Units.
- transmission : Coronavirus Infections, Pneumonia, Viral.
- trends : Hospital Mortality.
- virology : Coronavirus Infections, Pneumonia, Viral.
- Aged, COVID-19, Case-Control Studies, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Risk Reduction Behavior, SARS-CoV-2.

Abstract

BACKGROUND

There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.

METHODS

The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.

DISCUSSION

This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020.

DOI: 10.1186/s13063-020-04795-0
PubMed: 33081817
PubMed Central: PMC7573513

Affiliations:

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 000987
to stream Main, to step Curation: 000987

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en">Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.</title>
<author><name sortKey="Sivapalan, Pradeesh" sort="Sivapalan, Pradeesh" uniqKey="Sivapalan P" first="Pradeesh" last="Sivapalan">Pradeesh Sivapalan</name>
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<author><name sortKey="B Dtger, Uffe Christian Steinholtz" sort="B Dtger, Uffe Christian Steinholtz" uniqKey="B Dtger U" first="Uffe Christian Steinholtz" last="B Dtger">Uffe Christian Steinholtz B Dtger</name>
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<author><name sortKey="Browatzki, Andrea" sort="Browatzki, Andrea" uniqKey="Browatzki A" first="Andrea" last="Browatzki">Andrea Browatzki</name>
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<author><name sortKey="Meyer, Christian Niels" sort="Meyer, Christian Niels" uniqKey="Meyer C" first="Christian Niels" last="Meyer">Christian Niels Meyer</name>
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<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Zeeland University Hospital, Roskilde</wicri:regionArea>
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<author><name sortKey="Weinreich, Ulla M Ller" sort="Weinreich, Ulla M Ller" uniqKey="Weinreich U" first="Ulla M Ller" last="Weinreich">Ulla M Ller Weinreich</name>
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<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Aalborg University Hospital, Aalborg University, Aalborg</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Laursen, Christian B" sort="Laursen, Christian B" uniqKey="Laursen C" first="Christian B" last="Laursen">Christian B. Laursen</name>
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<country xml:lang="fr">Danemark</country>
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<wicri:noRegion>Odense</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Biering S Rensen, Tor" sort="Biering S Rensen, Tor" uniqKey="Biering S Rensen T" first="Tor" last="Biering-S Rensen">Tor Biering-S Rensen</name>
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<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen</wicri:regionArea>
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</affiliation>
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<author><name sortKey="Knop, Filip Krag" sort="Knop, Filip Krag" uniqKey="Knop F" first="Filip Krag" last="Knop">Filip Krag Knop</name>
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<country xml:lang="fr">Danemark</country>
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<placeName><settlement type="city">Copenhague</settlement>
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<author><name sortKey="Lundgren, Jens D" sort="Lundgren, Jens D" uniqKey="Lundgren J" first="Jens D" last="Lundgren">Jens D. Lundgren</name>
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<country xml:lang="fr">Danemark</country>
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<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jensen, Jens Ulrik St Hr" sort="Jensen, Jens Ulrik St Hr" uniqKey="Jensen J" first="Jens-Ulrik St Hr" last="Jensen">Jens-Ulrik St Hr Jensen</name>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged (MeSH)</term>
<term>Anti-Bacterial Agents (adverse effects)</term>
<term>Anti-Bacterial Agents (therapeutic use)</term>
<term>Antibiotic Prophylaxis (methods)</term>
<term>Antimalarials (adverse effects)</term>
<term>Antimalarials (therapeutic use)</term>
<term>Azithromycin (adverse effects)</term>
<term>Azithromycin (therapeutic use)</term>
<term>Betacoronavirus (drug effects)</term>
<term>Betacoronavirus (genetics)</term>
<term>COVID-19 (MeSH)</term>
<term>Case-Control Studies (MeSH)</term>
<term>Coronavirus Infections (epidemiology)</term>
<term>Coronavirus Infections (prevention & control)</term>
<term>Coronavirus Infections (transmission)</term>
<term>Coronavirus Infections (virology)</term>
<term>Denmark (epidemiology)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Drug Therapy, Combination (MeSH)</term>
<term>Female (MeSH)</term>
<term>Hospital Mortality (trends)</term>
<term>Hospitalization (statistics & numerical data)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>Intensive Care Units (statistics & numerical data)</term>
<term>Intention to Treat Analysis (methods)</term>
<term>Male (MeSH)</term>
<term>Noninvasive Ventilation (adverse effects)</term>
<term>Pandemics (prevention & control)</term>
<term>Placebos (administration & dosage)</term>
<term>Pneumonia, Viral (epidemiology)</term>
<term>Pneumonia, Viral (prevention & control)</term>
<term>Pneumonia, Viral (transmission)</term>
<term>Pneumonia, Viral (virology)</term>
<term>Risk Reduction Behavior (MeSH)</term>
<term>SARS-CoV-2 (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Analyse en intention de traitement (méthodes)</term>
<term>Antibactériens (effets indésirables)</term>
<term>Antibactériens (usage thérapeutique)</term>
<term>Antibioprophylaxie (méthodes)</term>
<term>Antipaludiques (effets indésirables)</term>
<term>Antipaludiques (usage thérapeutique)</term>
<term>Association de médicaments (MeSH)</term>
<term>Azithromycine (effets indésirables)</term>
<term>Azithromycine (usage thérapeutique)</term>
<term>Betacoronavirus (effets des médicaments et des substances chimiques)</term>
<term>Betacoronavirus (génétique)</term>
<term>Comportement de réduction des risques (MeSH)</term>
<term>Danemark (épidémiologie)</term>
<term>Femelle (MeSH)</term>
<term>Hospitalisation (statistiques et données numériques)</term>
<term>Humains (MeSH)</term>
<term>Hydroxychloroquine (effets indésirables)</term>
<term>Hydroxychloroquine (usage thérapeutique)</term>
<term>Infections à coronavirus (prévention et contrôle)</term>
<term>Infections à coronavirus (transmission)</term>
<term>Infections à coronavirus (virologie)</term>
<term>Infections à coronavirus (épidémiologie)</term>
<term>Mortalité hospitalière (tendances)</term>
<term>Mâle (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Pandémies (prévention et contrôle)</term>
<term>Placebo (administration et posologie)</term>
<term>Pneumopathie virale (prévention et contrôle)</term>
<term>Pneumopathie virale (transmission)</term>
<term>Pneumopathie virale (virologie)</term>
<term>Pneumopathie virale (épidémiologie)</term>
<term>Sujet âgé (MeSH)</term>
<term>Unités de soins intensifs (statistiques et données numériques)</term>
<term>Ventilation non effractive (effets indésirables)</term>
<term>Études cas-témoins (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Placebos</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anti-Bacterial Agents</term>
<term>Antimalarials</term>
<term>Azithromycin</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Bacterial Agents</term>
<term>Antimalarials</term>
<term>Azithromycin</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Denmark</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Placebo</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Noninvasive Ventilation</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antibactériens</term>
<term>Antipaludiques</term>
<term>Azithromycine</term>
<term>Hydroxychloroquine</term>
<term>Ventilation non effractive</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Antibiotic Prophylaxis</term>
<term>Intention to Treat Analysis</term>
</keywords>
<keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Analyse en intention de traitement</term>
<term>Antibioprophylaxie</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pandemics</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pandémies</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Hospitalization</term>
<term>Intensive Care Units</term>
</keywords>
<keywords scheme="MESH" qualifier="statistiques et données numériques" xml:lang="fr"><term>Hospitalisation</term>
<term>Unités de soins intensifs</term>
</keywords>
<keywords scheme="MESH" qualifier="tendances" xml:lang="fr"><term>Mortalité hospitalière</term>
</keywords>
<keywords scheme="MESH" qualifier="transmission" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="trends" xml:lang="en"><term>Hospital Mortality</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antibactériens</term>
<term>Antipaludiques</term>
<term>Azithromycine</term>
<term>Hydroxychloroquine</term>
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Danemark</term>
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>COVID-19</term>
<term>Case-Control Studies</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Risk Reduction Behavior</term>
<term>SARS-CoV-2</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Association de médicaments</term>
<term>Comportement de réduction des risques</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Sujet âgé</term>
<term>Études cas-témoins</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Danemark</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>DISCUSSION</b>
</p>
<p>This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b>
</p>
<p>ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33081817</PMID>
<DateCompleted><Year>2020</Year>
<Month>11</Month>
<Day>03</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>12</Month>
<Day>18</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>Oct</Month>
<Day>20</Day>
</PubDate>
</JournalIssue>
<Title>Trials</Title>
<ISOAbbreviation>Trials</ISOAbbreviation>
</Journal>
<ArticleTitle>Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.</ArticleTitle>
<Pagination><MedlinePgn>867</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-020-04795-0</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">The ProPAC-COVID is a multi-center, randomized, placebo-controlled, double-blinded clinical trial. The primary outcome is number of days spent alive and out of hospital within 14 days from randomization. Randomization will be in blocks of unknown size, and the final allocation will be stratified for age, site of recruitment, and whether the patient has any chronic lung diseases. Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis.</AbstractText>
<AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">This paper describes the detailed statistical analysis plan for the evaluation of primary and secondary endpoints of the ProPAC-COVID study. Enrolment of patients to the ProPAC-COVID study is still ongoing. The purpose of this paper is to provide primary publication of study results to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov NCT04322396 . Registered on 26 March 2020.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sivapalan</LastName>
<ForeName>Pradeesh</ForeName>
<Initials>P</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0002-8620-3655</Identifier>
<AffiliationInfo><Affiliation>Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. Pradeesh.s@dadlnet.dk.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ulrik</LastName>
<ForeName>Charlotte Suppli</ForeName>
<Initials>CS</Initials>
<AffiliationInfo><Affiliation>Amager and Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lappere</LastName>
<ForeName>Therese Sophie</ForeName>
<Initials>TS</Initials>
<AffiliationInfo><Affiliation>Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Eklöf</LastName>
<ForeName>Josefin Viktoria</ForeName>
<Initials>JV</Initials>
<AffiliationInfo><Affiliation>Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shaker</LastName>
<ForeName>Saher Burhan</ForeName>
<Initials>SB</Initials>
<AffiliationInfo><Affiliation>Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bødtger</LastName>
<ForeName>Uffe Christian Steinholtz</ForeName>
<Initials>UCS</Initials>
<AffiliationInfo><Affiliation>Næstved, Slagelse and Ringsted Hospitals, University of Southern Denmark, Odense, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Browatzki</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Nordsjællands Hospital Hillerød, University of Copenhagen, Hillerød, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Meyer</LastName>
<ForeName>Christian Niels</ForeName>
<Initials>CN</Initials>
<AffiliationInfo><Affiliation>Zeeland University Hospital, Roskilde, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Weinreich</LastName>
<ForeName>Ulla Møller</ForeName>
<Initials>UM</Initials>
<AffiliationInfo><Affiliation>Aalborg University Hospital, Aalborg University, Aalborg, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Laursen</LastName>
<ForeName>Christian B</ForeName>
<Initials>CB</Initials>
<AffiliationInfo><Affiliation>Odense University Hospital, University of Southern Denmark, Odense, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Biering-Sørensen</LastName>
<ForeName>Tor</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Knop</LastName>
<ForeName>Filip Krag</ForeName>
<Initials>FK</Initials>
<AffiliationInfo><Affiliation>Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lundgren</LastName>
<ForeName>Jens D</ForeName>
<Initials>JD</Initials>
<AffiliationInfo><Affiliation>Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jensen</LastName>
<ForeName>Jens-Ulrik Stæhr</ForeName>
<Initials>JS</Initials>
<AffiliationInfo><Affiliation>Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT04322396</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2020</Year>
<Month>10</Month>
<Day>20</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Trials</MedlineTA>
<NlmUniqueID>101263253</NlmUniqueID>
<ISSNLinking>1745-6215</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000900">Anti-Bacterial Agents</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000962">Antimalarials</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D010919">Placebos</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber>
<NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>83905-01-5</RegistryNumber>
<NameOfSubstance UI="D017963">Azithromycin</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000900" MajorTopicYN="N">Anti-Bacterial Agents</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D019072" MajorTopicYN="N">Antibiotic Prophylaxis</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000962" MajorTopicYN="N">Antimalarials</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017963" MajorTopicYN="N">Azithromycin</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName>
<QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
<QualifierName UI="Q000635" MajorTopicYN="N">transmission</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003718" MajorTopicYN="N" Type="Geographic">Denmark</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017052" MajorTopicYN="N">Hospital Mortality</DescriptorName>
<QualifierName UI="Q000639" MajorTopicYN="N">trends</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006760" MajorTopicYN="N">Hospitalization</DescriptorName>
<QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007362" MajorTopicYN="N">Intensive Care Units</DescriptorName>
<QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D057194" MajorTopicYN="N">Intention to Treat Analysis</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D063087" MajorTopicYN="N">Noninvasive Ventilation</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
<QualifierName UI="Q000635" MajorTopicYN="N">transmission</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D040242" MajorTopicYN="N">Risk Reduction Behavior</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Azithromycin</Keyword>
<Keyword MajorTopicYN="N">Detailed statistical analysis plan</Keyword>
<Keyword MajorTopicYN="N">Hydroxychloroquine</Keyword>
<Keyword MajorTopicYN="N">Infectious diseases</Keyword>
<Keyword MajorTopicYN="N">Intervention</Keyword>
<Keyword MajorTopicYN="N">Randomized controlled trial</Keyword>
<Keyword MajorTopicYN="N">Safety</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year>
<Month>06</Month>
<Day>18</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>10</Month>
<Day>10</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2020</Year>
<Month>10</Month>
<Day>21</Day>
<Hour>5</Hour>
<Minute>38</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2020</Year>
<Month>10</Month>
<Day>22</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2020</Year>
<Month>11</Month>
<Day>4</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>epublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">33081817</ArticleId>
<ArticleId IdType="doi">10.1186/s13063-020-04795-0</ArticleId>
<ArticleId IdType="pii">10.1186/s13063-020-04795-0</ArticleId>
<ArticleId IdType="pmc">PMC7573513</ArticleId>
</ArticleIdList>
<ReferenceList><Reference><Citation>JAMA. 2020 Apr 21;323(15):1499-1500</Citation>
<ArticleIdList><ArticleId IdType="pubmed">32159735</ArticleId>
</ArticleIdList>
</Reference>
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   |texte=   Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.
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	Serveur d'exploration COVID et hydrochloroquine
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Serveur d'exploration COVID et hydrochloroquine

Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.

Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan.

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