Serveur d'exploration MERS

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Feasibility of a randomized controlled trial to assess treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection in Saudi Arabia: a survey of physicians

Identifieur interne : 001697 ( Ncbi/Merge ); précédent : 001696; suivant : 001698

Feasibility of a randomized controlled trial to assess treatment of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection in Saudi Arabia: a survey of physicians

Auteurs : Yaseen M. Arabi [Arabie saoudite] ; Farhan Al-Enezi [Arabie saoudite] ; Kajsa-Stina Longuere ; Hanan H. Balkhy [Arabie saoudite] ; Mohamed Al-Sultan [Arabie saoudite] ; Awad Al-Omari [Arabie saoudite] ; Fahad M. Al-Hameed [Arabie saoudite] ; Gail Carson ; Nahoko Shindo [Suisse] ; Robert Fowler [Canada]

Source :

RBID : PMC:4942900

Descripteurs français

English descriptors

Abstract

Background

The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is an emerging respiratory pathogen with a high mortality rate and no specific treatments available to date. The purpose of this study was to determine the feasibility of conducting a randomized controlled trial (RCT) of convalescent plasma therapy for MERS-CoV-infected patients by using MERS-CoV-specific convalescent plasma obtained from previously recovered patients.

Methods

A survey was adapted from validated questionnaire originally aimed to measure network capacities and capabilities within the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC). The questionnaire was modified for this study to include 26 items that were divided into three main domains of interest: (1) the ability to care for critically ill MERS-CoV patients; (2) laboratory capacity to diagnose MERS-CoV and blood bank ability to prepare convalescent plasma; and (3), research capacity to conduct randomized controlled trials. The questionnaire was emailed to physicians.

Results

Of 582 physicians who were invited to the survey, 327 responded (56.2 %). The professional focus of the majority of respondents was critical care (106/249 (43 %)), pediatrics (59/249, (24 %)) or internal medicine (52/249 (21 %)) but none was blood banking. Nearly all respondents (251/263 (95 %)) reported to have access to ICU facilities within their institutions. Most respondents (219/270 (81 %)) reported that intensivists were the most physician group responsible for treatment decisions about critically ill SARI patients. While 125/165 respondents (76 %) reported that they conduct research in ICUs, and 80/161 (49.7 %) had been involved in the conduct of RCTs, including using a placebo comparison (60/161 (37 %)), only 49/226 (21 %) of respondents regularly participated in research networks.

Conclusions

Our survey indicated that in the Kingdom of Saudi Arabia (KSA), ICUs are the most likely clinical locations for conducting a clinical trial of convalescent plasma therapy for MERS-CoV, and that most ICUs have experience with such research designs.

Electronic supplementary material

The online version of this article (doi:10.1186/s12871-016-0198-x) contains supplementary material, which is available to authorized users.


Url:
DOI: 10.1186/s12871-016-0198-x
PubMed: 27405596
PubMed Central: 4942900

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PMC:4942900

Le document en format XML

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</keywords>
<keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en">
<term>Critical Care</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Coronavirus Infections</term>
</keywords>
<keywords scheme="MESH" qualifier="virologie" xml:lang="fr">
<term>Infections à coronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="virology" xml:lang="en">
<term>Coronavirus Infections</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Attitude of Health Personnel</term>
<term>Feasibility Studies</term>
<term>Humans</term>
<term>Middle East Respiratory Syndrome Coronavirus</term>
<term>Plasma Exchange</term>
<term>Saudi Arabia</term>
<term>Surveys and Questionnaires</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Arabie saoudite</term>
<term>Attitude du personnel soignant</term>
<term>Coronavirus du syndrome respiratoire du Moyen-Orient</term>
<term>Enquêtes et questionnaires</term>
<term>Essais contrôlés randomisés comme sujet</term>
<term>Humains</term>
<term>Infections à coronavirus</term>
<term>Soins de réanimation</term>
<term>Échange plasmatique</term>
<term>Études de faisabilité</term>
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<div type="abstract" xml:lang="en">
<sec>
<title>Background</title>
<p id="Par1">The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is an emerging respiratory pathogen with a high mortality rate and no specific treatments available to date. The purpose of this study was to determine the feasibility of conducting a randomized controlled trial (RCT) of convalescent plasma therapy for MERS-CoV-infected patients by using MERS-CoV-specific convalescent plasma obtained from previously recovered patients.</p>
</sec>
<sec>
<title>Methods</title>
<p id="Par2">A survey was adapted from validated questionnaire originally aimed to measure network capacities and capabilities within the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC). The questionnaire was modified for this study to include 26 items that were divided into three main domains of interest: (1) the ability to care for critically ill MERS-CoV patients; (2) laboratory capacity to diagnose MERS-CoV and blood bank ability to prepare convalescent plasma; and (3), research capacity to conduct randomized controlled trials. The questionnaire was emailed to physicians.</p>
</sec>
<sec>
<title>Results</title>
<p id="Par3">Of 582 physicians who were invited to the survey, 327 responded (56.2 %). The professional focus of the majority of respondents was critical care (106/249 (43 %)), pediatrics (59/249, (24 %)) or internal medicine (52/249 (21 %)) but none was blood banking. Nearly all respondents (251/263 (95 %)) reported to have access to ICU facilities within their institutions. Most respondents (219/270 (81 %)) reported that intensivists were the most physician group responsible for treatment decisions about critically ill SARI patients. While 125/165 respondents (76 %) reported that they conduct research in ICUs, and 80/161 (49.7 %) had been involved in the conduct of RCTs, including using a placebo comparison (60/161 (37 %)), only 49/226 (21 %) of respondents regularly participated in research networks.</p>
</sec>
<sec>
<title>Conclusions</title>
<p id="Par4">Our survey indicated that in the Kingdom of Saudi Arabia (KSA), ICUs are the most likely clinical locations for conducting a clinical trial of convalescent plasma therapy for MERS-CoV, and that most ICUs have experience with such research designs.</p>
</sec>
<sec>
<title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12871-016-0198-x) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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<name sortKey="Carson, Gail" sort="Carson, Gail" uniqKey="Carson G" first="Gail" last="Carson">Gail Carson</name>
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<name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H." last="Balkhy">Hanan H. Balkhy</name>
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<wicri:regionArea>Riyadh</wicri:regionArea>
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<name sortKey="Al Sultan, Mohamed" sort="Al Sultan, Mohamed" uniqKey="Al Sultan M" first="Mohamed" last="Al-Sultan">Mohamed Al-Sultan</name>
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Riyadh, Saudi Arabia</nlm:aff>
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<wicri:regionArea>Riyadh</wicri:regionArea>
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</author>
<author>
<name sortKey="Al Omari, Awad" sort="Al Omari, Awad" uniqKey="Al Omari A" first="Awad" last="Al-Omari">Awad Al-Omari</name>
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<nlm:aff id="Aff5">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.411335.1</institution-id>
<institution-id institution-id-type="ISNI">0000000417587207</institution-id>
<institution>AlFaisal University,</institution>
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Riyadh, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Riyadh</wicri:regionArea>
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</author>
<author>
<name sortKey="Al Hameed, Fahad M" sort="Al Hameed, Fahad M" uniqKey="Al Hameed F" first="Fahad M." last="Al-Hameed">Fahad M. Al-Hameed</name>
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<institution-id institution-id-type="GRID">grid.415254.3</institution-id>
<institution-id institution-id-type="ISNI">0000000417907311</institution-id>
<institution>Critical Care & Pulmonary Medicine,</institution>
<institution>King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City,</institution>
</institution-wrap>
Jeddah, Saudi Arabia</nlm:aff>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Jeddah</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Carson, Gail" sort="Carson, Gail" uniqKey="Carson G" first="Gail" last="Carson">Gail Carson</name>
<affiliation>
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.4991.5</institution-id>
<institution-id institution-id-type="ISNI">0000000419368948</institution-id>
<institution>University of Oxford Centre for Tropical Medicine (CCVTM),</institution>
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Churchill Hospital Old Road, Headington, Oxford, OX3 7LE UK</nlm:aff>
<wicri:noCountry code="subfield">OX3 7LE UK</wicri:noCountry>
</affiliation>
<affiliation>
<nlm:aff id="Aff10">International Severe Acute Respiratory & emerging Infection Consortium (ISARIC), Old Road Campus, Headington, OX3 7FZ UK</nlm:aff>
<wicri:noCountry code="subfield">OX3 7FZ UK</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Shindo, Nahoko" sort="Shindo, Nahoko" uniqKey="Shindo N" first="Nahoko" last="Shindo">Nahoko Shindo</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff7">
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<institution-id institution-id-type="GRID">grid.3575.4</institution-id>
<institution-id institution-id-type="ISNI">0000000121633745</institution-id>
<institution>Pandemic and Epidemic Diseases Department,</institution>
<institution>World Health Organization,</institution>
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Geneva, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Geneva</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Fowler, Robert" sort="Fowler, Robert" uniqKey="Fowler R" first="Robert" last="Fowler">Robert Fowler</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff8">
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<institution-id institution-id-type="GRID">grid.17063.33</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 2157 2938</institution-id>
<institution>Department of Medicine and Institute of Health Policy Management and Evaluation,</institution>
<institution>University of Toronto,</institution>
</institution-wrap>
Toronto, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Toronto</wicri:regionArea>
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<affiliation wicri:level="1">
<nlm:aff id="Aff9">
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<institution-id institution-id-type="GRID">grid.413104.3</institution-id>
<institution-id institution-id-type="ISNI">0000000097431587</institution-id>
<institution>Department of Medicine and Interdepartmental Division of Critical Care Medicine,</institution>
<institution>Sunnybrook Health Sciences Centre,</institution>
</institution-wrap>
Toronto, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Toronto</wicri:regionArea>
</affiliation>
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</analytic>
<series>
<title level="j">BMC Anesthesiology</title>
<idno type="eISSN">1471-2253</idno>
<imprint>
<date when="2016">2016</date>
</imprint>
</series>
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<textClass></textClass>
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<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Background</title>
<p id="Par1">The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is an emerging respiratory pathogen with a high mortality rate and no specific treatments available to date. The purpose of this study was to determine the feasibility of conducting a randomized controlled trial (RCT) of convalescent plasma therapy for MERS-CoV-infected patients by using MERS-CoV-specific convalescent plasma obtained from previously recovered patients.</p>
</sec>
<sec>
<title>Methods</title>
<p id="Par2">A survey was adapted from validated questionnaire originally aimed to measure network capacities and capabilities within the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC). The questionnaire was modified for this study to include 26 items that were divided into three main domains of interest: (1) the ability to care for critically ill MERS-CoV patients; (2) laboratory capacity to diagnose MERS-CoV and blood bank ability to prepare convalescent plasma; and (3), research capacity to conduct randomized controlled trials. The questionnaire was emailed to physicians.</p>
</sec>
<sec>
<title>Results</title>
<p id="Par3">Of 582 physicians who were invited to the survey, 327 responded (56.2 %). The professional focus of the majority of respondents was critical care (106/249 (43 %)), pediatrics (59/249, (24 %)) or internal medicine (52/249 (21 %)) but none was blood banking. Nearly all respondents (251/263 (95 %)) reported to have access to ICU facilities within their institutions. Most respondents (219/270 (81 %)) reported that intensivists were the most physician group responsible for treatment decisions about critically ill SARI patients. While 125/165 respondents (76 %) reported that they conduct research in ICUs, and 80/161 (49.7 %) had been involved in the conduct of RCTs, including using a placebo comparison (60/161 (37 %)), only 49/226 (21 %) of respondents regularly participated in research networks.</p>
</sec>
<sec>
<title>Conclusions</title>
<p id="Par4">Our survey indicated that in the Kingdom of Saudi Arabia (KSA), ICUs are the most likely clinical locations for conducting a clinical trial of convalescent plasma therapy for MERS-CoV, and that most ICUs have experience with such research designs.</p>
</sec>
<sec>
<title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12871-016-0198-x) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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<nlm:affiliation>Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, PO Box 22490, Riyadh, 11426, Saudi Arabia. arabi@ngha.med.sa.</nlm:affiliation>
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<name sortKey="Al Enezi, Farhan" sort="Al Enezi, Farhan" uniqKey="Al Enezi F" first="Farhan" last="Al-Enezi">Farhan Al-Enezi</name>
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<name sortKey="Longuere, Kajsa Stina" sort="Longuere, Kajsa Stina" uniqKey="Longuere K" first="Kajsa-Stina" last="Longuere">Kajsa-Stina Longuere</name>
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<country xml:lang="fr">Arabie saoudite</country>
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<name sortKey="Al Omari, Awad" sort="Al Omari, Awad" uniqKey="Al Omari A" first="Awad" last="Al-Omari">Awad Al-Omari</name>
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<name sortKey="Al Hameed, Fahad M" sort="Al Hameed, Fahad M" uniqKey="Al Hameed F" first="Fahad M" last="Al-Hameed">Fahad M. Al-Hameed</name>
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<name sortKey="Shindo, Nahoko" sort="Shindo, Nahoko" uniqKey="Shindo N" first="Nahoko" last="Shindo">Nahoko Shindo</name>
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<name sortKey="Fowler, Robert" sort="Fowler, Robert" uniqKey="Fowler R" first="Robert" last="Fowler">Robert Fowler</name>
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<name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M" last="Arabi">Yaseen M. Arabi</name>
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<name sortKey="Longuere, Kajsa Stina" sort="Longuere, Kajsa Stina" uniqKey="Longuere K" first="Kajsa-Stina" last="Longuere">Kajsa-Stina Longuere</name>
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<name sortKey="Al Sultan, Mohamed" sort="Al Sultan, Mohamed" uniqKey="Al Sultan M" first="Mohamed" last="Al-Sultan">Mohamed Al-Sultan</name>
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<name sortKey="Al Omari, Awad" sort="Al Omari, Awad" uniqKey="Al Omari A" first="Awad" last="Al-Omari">Awad Al-Omari</name>
<affiliation wicri:level="1">
<nlm:affiliation>AlFaisal University, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>AlFaisal University, Riyadh</wicri:regionArea>
<wicri:noRegion>Riyadh</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Al Hameed, Fahad M" sort="Al Hameed, Fahad M" uniqKey="Al Hameed F" first="Fahad M" last="Al-Hameed">Fahad M. Al-Hameed</name>
<affiliation wicri:level="1">
<nlm:affiliation>Critical Care & Pulmonary Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Critical Care & Pulmonary Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah</wicri:regionArea>
<wicri:noRegion>Jeddah</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Carson, Gail" sort="Carson, Gail" uniqKey="Carson G" first="Gail" last="Carson">Gail Carson</name>
<affiliation wicri:level="1">
<nlm:affiliation>University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE</wicri:regionArea>
<wicri:noRegion>OX3 7LE</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Shindo, Nahoko" sort="Shindo, Nahoko" uniqKey="Shindo N" first="Nahoko" last="Shindo">Nahoko Shindo</name>
<affiliation wicri:level="1">
<nlm:affiliation>Pandemic and Epidemic Diseases Department, World Health Organization, Geneva, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Pandemic and Epidemic Diseases Department, World Health Organization, Geneva</wicri:regionArea>
<wicri:noRegion>Geneva</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Fowler, Robert" sort="Fowler, Robert" uniqKey="Fowler R" first="Robert" last="Fowler">Robert Fowler</name>
<affiliation wicri:level="4">
<nlm:affiliation>Department of Medicine and Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Medicine and Institute of Health Policy Management and Evaluation, University of Toronto, Toronto</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
<placeName>
<settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
</author>
</analytic>
<series>
<title level="j">BMC anesthesiology</title>
<idno type="eISSN">1471-2253</idno>
<imprint>
<date when="2016" type="published">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Attitude of Health Personnel</term>
<term>Coronavirus Infections (blood)</term>
<term>Coronavirus Infections (therapy)</term>
<term>Coronavirus Infections (virology)</term>
<term>Critical Care (statistics & numerical data)</term>
<term>Feasibility Studies</term>
<term>Humans</term>
<term>Middle East Respiratory Syndrome Coronavirus</term>
<term>Physicians (psychology)</term>
<term>Plasma Exchange</term>
<term>Randomized Controlled Trials as Topic (methods)</term>
<term>Saudi Arabia</term>
<term>Surveys and Questionnaires</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Arabie saoudite</term>
<term>Attitude du personnel soignant</term>
<term>Coronavirus du syndrome respiratoire du Moyen-Orient</term>
<term>Enquêtes et questionnaires</term>
<term>Essais contrôlés randomisés comme sujet ()</term>
<term>Humains</term>
<term>Infections à coronavirus ()</term>
<term>Infections à coronavirus (sang)</term>
<term>Infections à coronavirus (virologie)</term>
<term>Médecins (psychologie)</term>
<term>Soins de réanimation ()</term>
<term>Échange plasmatique</term>
<term>Études de faisabilité</term>
</keywords>
<keywords scheme="MESH" qualifier="blood" xml:lang="en">
<term>Coronavirus Infections</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Randomized Controlled Trials as Topic</term>
</keywords>
<keywords scheme="MESH" qualifier="psychologie" xml:lang="fr">
<term>Médecins</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en">
<term>Physicians</term>
</keywords>
<keywords scheme="MESH" qualifier="sang" xml:lang="fr">
<term>Infections à coronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en">
<term>Critical Care</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Coronavirus Infections</term>
</keywords>
<keywords scheme="MESH" qualifier="virologie" xml:lang="fr">
<term>Infections à coronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="virology" xml:lang="en">
<term>Coronavirus Infections</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Attitude of Health Personnel</term>
<term>Feasibility Studies</term>
<term>Humans</term>
<term>Middle East Respiratory Syndrome Coronavirus</term>
<term>Plasma Exchange</term>
<term>Saudi Arabia</term>
<term>Surveys and Questionnaires</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Arabie saoudite</term>
<term>Attitude du personnel soignant</term>
<term>Coronavirus du syndrome respiratoire du Moyen-Orient</term>
<term>Enquêtes et questionnaires</term>
<term>Essais contrôlés randomisés comme sujet</term>
<term>Humains</term>
<term>Infections à coronavirus</term>
<term>Soins de réanimation</term>
<term>Échange plasmatique</term>
<term>Études de faisabilité</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is an emerging respiratory pathogen with a high mortality rate and no specific treatments available to date. The purpose of this study was to determine the feasibility of conducting a randomized controlled trial (RCT) of convalescent plasma therapy for MERS-CoV-infected patients by using MERS-CoV-specific convalescent plasma obtained from previously recovered patients.</div>
</front>
</TEI>
</pubmed>
</double>
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