Serveur d'exploration COVID et hydrochloroquine

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Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial.

Identifieur interne : 001142 ( Main/Exploration ); précédent : 001141; suivant : 001143

Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial.

Auteurs : Samuel M. Brown ; Ithan D. Peltan ; Brandon Webb [États-Unis] ; Naresh Kumar ; Nathan Starr [États-Unis] ; Colin Grissom ; Whitney R. Buckel ; Raj Srivastava [États-Unis] ; Estelle S. Harris ; Lindsay M. Leither ; Stacy A. Johnson ; Robert Paine ; Tom Greene [États-Unis]

Source :

RBID : pubmed:32425051

Descripteurs français

English descriptors

Abstract

Coronavirus disease (COVID-19) is a potentially fatal illness with no proven therapy beyond excellent supportive care. Treatments are urgently sought. Adaptations to traditional trial logistics and design to allow rapid implementation, evaluation of trials within a global trials context, flexible interim monitoring, and access outside traditional research hospitals (even in settings where formal placebos are unavailable) may be helpful. Thoughtful adaptations to traditional trial designs, especially within the global context of related studies, may also foster collaborative relationships among government, community, and the research enterprise. Here, we describe the protocol for a pragmatic, active comparator trial in as many as 300 patients comparing two current "off-label" treatments for COVID-19-hydroxychloroquine and azithromycin-in academic and nonacademic hospitals in Utah. We developed the trial in response to local pressures for widespread, indiscriminate off-label use of these medications. We used a hybrid Bayesian-frequentist design for interim monitoring to allow rapid, contextual assessment of the available evidence. We also developed an inference grid for interpreting the range of possible results from this trial within the context of parallel trials and prepared for a network meta-analysis of the resulting data. This trial was prospectively registered (ClinicalTrials.gov Identifier: NCT04329832) before enrollment of the first patient.Clinical trial registered with www.clinicaltrials.gov (NCT04329832).

DOI: 10.1513/AnnalsATS.202004-309SD
PubMed: 32425051
PubMed Central: PMC7393787


Affiliations:


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Le document en format XML

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<name sortKey="Buckel, Whitney R" sort="Buckel, Whitney R" uniqKey="Buckel W" first="Whitney R" last="Buckel">Whitney R. Buckel</name>
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<name sortKey="Srivastava, Raj" sort="Srivastava, Raj" uniqKey="Srivastava R" first="Raj" last="Srivastava">Raj Srivastava</name>
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<nlm:affiliation>Inpatient Medicine, Department of Pediatrics.</nlm:affiliation>
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<region type="state">Utah</region>
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<name sortKey="Harris, Estelle S" sort="Harris, Estelle S" uniqKey="Harris E" first="Estelle S" last="Harris">Estelle S. Harris</name>
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<name sortKey="Leither, Lindsay M" sort="Leither, Lindsay M" uniqKey="Leither L" first="Lindsay M" last="Leither">Lindsay M. Leither</name>
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<name sortKey="Johnson, Stacy A" sort="Johnson, Stacy A" uniqKey="Johnson S" first="Stacy A" last="Johnson">Stacy A. Johnson</name>
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<name sortKey="Paine, Robert" sort="Paine, Robert" uniqKey="Paine R" first="Robert" last="Paine">Robert Paine</name>
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<name sortKey="Greene, Tom" sort="Greene, Tom" uniqKey="Greene T" first="Tom" last="Greene">Tom Greene</name>
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<term>Adult (MeSH)</term>
<term>Anti-Infective Agents (administration & dosage)</term>
<term>Anti-Infective Agents (adverse effects)</term>
<term>Azithromycin (administration & dosage)</term>
<term>Azithromycin (adverse effects)</term>
<term>Betacoronavirus (drug effects)</term>
<term>Betacoronavirus (isolation & purification)</term>
<term>COVID-19 (MeSH)</term>
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<term>Coronavirus Infections (drug therapy)</term>
<term>Coronavirus Infections (epidemiology)</term>
<term>Drug Monitoring (methods)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (administration & dosage)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Male (MeSH)</term>
<term>Pandemics (MeSH)</term>
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<term>Pneumonia, Viral (epidemiology)</term>
<term>Randomized Controlled Trials as Topic (MeSH)</term>
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<term>Essais contrôlés randomisés comme sujet (MeSH)</term>
<term>Femelle (MeSH)</term>
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<term>Pneumonia, Viral</term>
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<term>Pneumopathie virale</term>
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<term>Coronavirus Infections</term>
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<term>Azithromycine</term>
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<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
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<term>Betacoronavirus</term>
</keywords>
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<term>Infections à coronavirus</term>
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<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
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<term>Adult</term>
<term>COVID-19</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
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<term>Randomized Controlled Trials as Topic</term>
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<term>Adulte</term>
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<div type="abstract" xml:lang="en">Coronavirus disease (COVID-19) is a potentially fatal illness with no proven therapy beyond excellent supportive care. Treatments are urgently sought. Adaptations to traditional trial logistics and design to allow rapid implementation, evaluation of trials within a global trials context, flexible interim monitoring, and access outside traditional research hospitals (even in settings where formal placebos are unavailable) may be helpful. Thoughtful adaptations to traditional trial designs, especially within the global context of related studies, may also foster collaborative relationships among government, community, and the research enterprise. Here, we describe the protocol for a pragmatic, active comparator trial in as many as 300 patients comparing two current "off-label" treatments for COVID-19-hydroxychloroquine and azithromycin-in academic and nonacademic hospitals in Utah. We developed the trial in response to local pressures for widespread, indiscriminate off-label use of these medications. We used a hybrid Bayesian-frequentist design for interim monitoring to allow rapid, contextual assessment of the available evidence. We also developed an inference grid for interpreting the range of possible results from this trial within the context of parallel trials and prepared for a network meta-analysis of the resulting data. This trial was prospectively registered (ClinicalTrials.gov Identifier: NCT04329832) before enrollment of the first patient.Clinical trial registered with www.clinicaltrials.gov (NCT04329832).</div>
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<Title>Annals of the American Thoracic Society</Title>
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<name sortKey="Leither, Lindsay M" sort="Leither, Lindsay M" uniqKey="Leither L" first="Lindsay M" last="Leither">Lindsay M. Leither</name>
<name sortKey="Paine, Robert" sort="Paine, Robert" uniqKey="Paine R" first="Robert" last="Paine">Robert Paine</name>
<name sortKey="Peltan, Ithan D" sort="Peltan, Ithan D" uniqKey="Peltan I" first="Ithan D" last="Peltan">Ithan D. Peltan</name>
</noCountry>
<country name="États-Unis">
<region name="Californie">
<name sortKey="Webb, Brandon" sort="Webb, Brandon" uniqKey="Webb B" first="Brandon" last="Webb">Brandon Webb</name>
</region>
<name sortKey="Greene, Tom" sort="Greene, Tom" uniqKey="Greene T" first="Tom" last="Greene">Tom Greene</name>
<name sortKey="Srivastava, Raj" sort="Srivastava, Raj" uniqKey="Srivastava R" first="Raj" last="Srivastava">Raj Srivastava</name>
<name sortKey="Starr, Nathan" sort="Starr, Nathan" uniqKey="Starr N" first="Nathan" last="Starr">Nathan Starr</name>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/CovidChloroV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001142 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001142 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    CovidChloroV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     pubmed:32425051
   |texte=   Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial.
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i   -Sk "pubmed:32425051" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd   \
       | NlmPubMed2Wicri -a CovidChloroV1 

Wicri

This area was generated with Dilib version V0.6.38.
Data generation: Sat May 22 17:02:32 2021. Site generation: Sat May 22 17:06:52 2021