Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol.
Identifieur interne : 001366 ( PubMed/Corpus ); précédent : 001365; suivant : 001367Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol.
Auteurs : Yaseen Arabi ; Hanan Balkhy ; Ali H. Hajeer ; Abderrezak Bouchama ; Frederick G. Hayden ; Awad Al-Omari ; Fahad M. Al-Hameed ; Yusri Taha ; Nahoko Shindo ; John Whitehead ; Laura Merson ; Sameera Aljohani ; Khalid Al-Khairy ; Gail Carson ; Thomas C. Luke ; Lisa Hensley ; Abdulaziz Al-Dawood ; Saad Al-Qahtani ; Kayvon Modjarrad ; Musharaf Sadat ; Gernot Rohde ; Catherine Leport ; Robert FowlerSource :
- SpringerPlus [ 2193-1801 ] ; 2015.
Abstract
As of September 30, 2015, a total of 1589 laboratory-confirmed cases of infection with the Middle East respiratory syndrome coronavirus (MERS-CoV) have been reported to the World Health Organization (WHO). At present there is no effective specific therapy against MERS-CoV. The use of convalescent plasma (CP) has been suggested as a potential therapy based on existing evidence from other viral infections. We aim to study the feasibility of CP therapy as well as its safety and clinical and laboratory effects in critically ill patients with MERS-CoV infection. We will also examine the pharmacokinetics of the MERS-CoV antibody response and viral load over the course of MERS-CoV infection. This study will inform a future randomized controlled trial that will examine the efficacy of CP therapy for MERS-CoV infection. In the CP collection phase, potential donors will be tested by the enzyme linked immunosorbent assay (ELISA) and the indirect fluorescent antibody (IFA) techniques for the presence of anti-MERS-CoV antibodies. Subjects with anti-MERS-CoV IFA titer of ≥1:160 and no clinical or laboratory evidence of MERS-CoV infection will be screened for eligibility for plasma donation according to standard donation criteria. In the CP therapy phase, 20 consecutive critically ill patients admitted to intensive care unit with laboratory-confirmed MERS-CoV infection will be enrolled and each will receive 2 units of CP. Post enrollment, patients will be followed for clinical and laboratory outcomes that include anti-MERS-CoV antibodies and viral load. This protocol was developed collaboratively by King Abdullah International Medical Research Center (KAIMRC), Gulf Cooperation Council (GCC) Infection Control Center Group and the World Health Organization-International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC-WHO) MERS-CoV Working Group. It was approved in June 2014 by the Ministry of the National Guard Health Affairs Institutional Review Board (IRB). A data safety monitoring board (DSMB) was formulated. The study is registered at http://www.clinicaltrials.gov (NCT02190799).
DOI: 10.1186/s40064-015-1490-9
PubMed: 26618098
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol.</title><author><name sortKey="Arabi, Yaseen" sort="Arabi, Yaseen" uniqKey="Arabi Y" first="Yaseen" last="Arabi">Yaseen Arabi</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Balkhy, Hanan" sort="Balkhy, Hanan" uniqKey="Balkhy H" first="Hanan" last="Balkhy">Hanan Balkhy</name><affiliation><nlm:affiliation>Infection Control Department, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Hajeer, Ali H" sort="Hajeer, Ali H" uniqKey="Hajeer A" first="Ali H" last="Hajeer">Ali H. Hajeer</name><affiliation><nlm:affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Bouchama, Abderrezak" sort="Bouchama, Abderrezak" uniqKey="Bouchama A" first="Abderrezak" last="Bouchama">Abderrezak Bouchama</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G" last="Hayden">Frederick G. Hayden</name><affiliation><nlm:affiliation>Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA USA.</nlm:affiliation></affiliation></author><author><name sortKey="Al Omari, Awad" sort="Al Omari, Awad" uniqKey="Al Omari A" first="Awad" last="Al-Omari">Awad Al-Omari</name><affiliation><nlm:affiliation>Critical Care and Infection Control Department, Security Forces Hospital, AlFaisal University, Riyadh, Saudi Arabia.</nlm:affiliation></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><nlm:affiliation>Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Taha, Yusri" sort="Taha, Yusri" uniqKey="Taha Y" first="Yusri" last="Taha">Yusri Taha</name><affiliation><nlm:affiliation>Infectious Diseases, Department of Medicine, King Abdulaziz Medical City, Al-Ahsa, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Shindo, Nahoko" sort="Shindo, Nahoko" uniqKey="Shindo N" first="Nahoko" last="Shindo">Nahoko Shindo</name><affiliation><nlm:affiliation>Pandemic and Epidemic Diseases Department, World Health Organization, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Whitehead, John" sort="Whitehead, John" uniqKey="Whitehead J" first="John" last="Whitehead">John Whitehead</name><affiliation><nlm:affiliation>Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Merson, Laura" sort="Merson, Laura" uniqKey="Merson L" first="Laura" last="Merson">Laura Merson</name><affiliation><nlm:affiliation>Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, Ward 1, District 5, Ho Chi Minh City, Vietnam.</nlm:affiliation></affiliation></author><author><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name><affiliation><nlm:affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Khairy, Khalid" sort="Al Khairy, Khalid" uniqKey="Al Khairy K" first="Khalid" last="Al-Khairy">Khalid Al-Khairy</name><affiliation><nlm:affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Carson, Gail" sort="Carson, Gail" uniqKey="Carson G" first="Gail" last="Carson">Gail Carson</name><affiliation><nlm:affiliation>University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE UK.</nlm:affiliation></affiliation></author><author><name sortKey="Luke, Thomas C" sort="Luke, Thomas C" uniqKey="Luke T" first="Thomas C" last="Luke">Thomas C. Luke</name><affiliation><nlm:affiliation>Viral and Rickettsial Diseases Department, Naval Medical Research Center, The Henry Jackson Foundation, 6720A Rockledge Drive #100, Bethesda, MD 20817 USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hensley, Lisa" sort="Hensley, Lisa" uniqKey="Hensley L" first="Lisa" last="Hensley">Lisa Hensley</name><affiliation><nlm:affiliation>Integrated Research Facility, National Institute of Allergy and Infectious Diseases, Frederick, MD USA.</nlm:affiliation></affiliation></author><author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Qahtani, Saad" sort="Al Qahtani, Saad" uniqKey="Al Qahtani S" first="Saad" last="Al-Qahtani">Saad Al-Qahtani</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Modjarrad, Kayvon" sort="Modjarrad, Kayvon" uniqKey="Modjarrad K" first="Kayvon" last="Modjarrad">Kayvon Modjarrad</name><affiliation><nlm:affiliation>U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910 USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sadat, Musharaf" sort="Sadat, Musharaf" uniqKey="Sadat M" first="Musharaf" last="Sadat">Musharaf Sadat</name><affiliation><nlm:affiliation>Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Rohde, Gernot" sort="Rohde, Gernot" uniqKey="Rohde G" first="Gernot" last="Rohde">Gernot Rohde</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Maastricht University Medical Center, P. Debyelaan 25, 6202AZ Maastricht, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Leport, Catherine" sort="Leport, Catherine" uniqKey="Leport C" first="Catherine" last="Leport">Catherine Leport</name><affiliation><nlm:affiliation>The French Infectious Disease Society, Universite Paris Diderot, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Fowler, Robert" sort="Fowler, Robert" uniqKey="Fowler R" first="Robert" last="Fowler">Robert Fowler</name><affiliation><nlm:affiliation>Department of Medicine and Institute of Health Policy Management and Evaluation, AMR Infection Control and Publications AIP/PED/HSE/HQ, University of Toronto, Toronto, Canada ; Department of Critical Care Medicine and Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26618098</idno><idno type="pmid">26618098</idno><idno type="doi">10.1186/s40064-015-1490-9</idno><idno type="wicri:Area/PubMed/Corpus">001366</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001366</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol.</title><author><name sortKey="Arabi, Yaseen" sort="Arabi, Yaseen" uniqKey="Arabi Y" first="Yaseen" last="Arabi">Yaseen Arabi</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Balkhy, Hanan" sort="Balkhy, Hanan" uniqKey="Balkhy H" first="Hanan" last="Balkhy">Hanan Balkhy</name><affiliation><nlm:affiliation>Infection Control Department, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Hajeer, Ali H" sort="Hajeer, Ali H" uniqKey="Hajeer A" first="Ali H" last="Hajeer">Ali H. Hajeer</name><affiliation><nlm:affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Bouchama, Abderrezak" sort="Bouchama, Abderrezak" uniqKey="Bouchama A" first="Abderrezak" last="Bouchama">Abderrezak Bouchama</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G" last="Hayden">Frederick G. Hayden</name><affiliation><nlm:affiliation>Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA USA.</nlm:affiliation></affiliation></author><author><name sortKey="Al Omari, Awad" sort="Al Omari, Awad" uniqKey="Al Omari A" first="Awad" last="Al-Omari">Awad Al-Omari</name><affiliation><nlm:affiliation>Critical Care and Infection Control Department, Security Forces Hospital, AlFaisal University, Riyadh, Saudi Arabia.</nlm:affiliation></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><nlm:affiliation>Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Taha, Yusri" sort="Taha, Yusri" uniqKey="Taha Y" first="Yusri" last="Taha">Yusri Taha</name><affiliation><nlm:affiliation>Infectious Diseases, Department of Medicine, King Abdulaziz Medical City, Al-Ahsa, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Shindo, Nahoko" sort="Shindo, Nahoko" uniqKey="Shindo N" first="Nahoko" last="Shindo">Nahoko Shindo</name><affiliation><nlm:affiliation>Pandemic and Epidemic Diseases Department, World Health Organization, Geneva, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Whitehead, John" sort="Whitehead, John" uniqKey="Whitehead J" first="John" last="Whitehead">John Whitehead</name><affiliation><nlm:affiliation>Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Merson, Laura" sort="Merson, Laura" uniqKey="Merson L" first="Laura" last="Merson">Laura Merson</name><affiliation><nlm:affiliation>Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, Ward 1, District 5, Ho Chi Minh City, Vietnam.</nlm:affiliation></affiliation></author><author><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name><affiliation><nlm:affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Khairy, Khalid" sort="Al Khairy, Khalid" uniqKey="Al Khairy K" first="Khalid" last="Al-Khairy">Khalid Al-Khairy</name><affiliation><nlm:affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Carson, Gail" sort="Carson, Gail" uniqKey="Carson G" first="Gail" last="Carson">Gail Carson</name><affiliation><nlm:affiliation>University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE UK.</nlm:affiliation></affiliation></author><author><name sortKey="Luke, Thomas C" sort="Luke, Thomas C" uniqKey="Luke T" first="Thomas C" last="Luke">Thomas C. Luke</name><affiliation><nlm:affiliation>Viral and Rickettsial Diseases Department, Naval Medical Research Center, The Henry Jackson Foundation, 6720A Rockledge Drive #100, Bethesda, MD 20817 USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hensley, Lisa" sort="Hensley, Lisa" uniqKey="Hensley L" first="Lisa" last="Hensley">Lisa Hensley</name><affiliation><nlm:affiliation>Integrated Research Facility, National Institute of Allergy and Infectious Diseases, Frederick, MD USA.</nlm:affiliation></affiliation></author><author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Qahtani, Saad" sort="Al Qahtani, Saad" uniqKey="Al Qahtani S" first="Saad" last="Al-Qahtani">Saad Al-Qahtani</name><affiliation><nlm:affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Modjarrad, Kayvon" sort="Modjarrad, Kayvon" uniqKey="Modjarrad K" first="Kayvon" last="Modjarrad">Kayvon Modjarrad</name><affiliation><nlm:affiliation>U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910 USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sadat, Musharaf" sort="Sadat, Musharaf" uniqKey="Sadat M" first="Musharaf" last="Sadat">Musharaf Sadat</name><affiliation><nlm:affiliation>Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Rohde, Gernot" sort="Rohde, Gernot" uniqKey="Rohde G" first="Gernot" last="Rohde">Gernot Rohde</name><affiliation><nlm:affiliation>Department of Respiratory Medicine, Maastricht University Medical Center, P. Debyelaan 25, 6202AZ Maastricht, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Leport, Catherine" sort="Leport, Catherine" uniqKey="Leport C" first="Catherine" last="Leport">Catherine Leport</name><affiliation><nlm:affiliation>The French Infectious Disease Society, Universite Paris Diderot, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Fowler, Robert" sort="Fowler, Robert" uniqKey="Fowler R" first="Robert" last="Fowler">Robert Fowler</name><affiliation><nlm:affiliation>Department of Medicine and Institute of Health Policy Management and Evaluation, AMR Infection Control and Publications AIP/PED/HSE/HQ, University of Toronto, Toronto, Canada ; Department of Critical Care Medicine and Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada.</nlm:affiliation></affiliation></author></analytic><series><title level="j">SpringerPlus</title><idno type="ISSN">2193-1801</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">As of September 30, 2015, a total of 1589 laboratory-confirmed cases of infection with the Middle East respiratory syndrome coronavirus (MERS-CoV) have been reported to the World Health Organization (WHO). At present there is no effective specific therapy against MERS-CoV. The use of convalescent plasma (CP) has been suggested as a potential therapy based on existing evidence from other viral infections. We aim to study the feasibility of CP therapy as well as its safety and clinical and laboratory effects in critically ill patients with MERS-CoV infection. We will also examine the pharmacokinetics of the MERS-CoV antibody response and viral load over the course of MERS-CoV infection. This study will inform a future randomized controlled trial that will examine the efficacy of CP therapy for MERS-CoV infection. In the CP collection phase, potential donors will be tested by the enzyme linked immunosorbent assay (ELISA) and the indirect fluorescent antibody (IFA) techniques for the presence of anti-MERS-CoV antibodies. Subjects with anti-MERS-CoV IFA titer of ≥1:160 and no clinical or laboratory evidence of MERS-CoV infection will be screened for eligibility for plasma donation according to standard donation criteria. In the CP therapy phase, 20 consecutive critically ill patients admitted to intensive care unit with laboratory-confirmed MERS-CoV infection will be enrolled and each will receive 2 units of CP. Post enrollment, patients will be followed for clinical and laboratory outcomes that include anti-MERS-CoV antibodies and viral load. This protocol was developed collaboratively by King Abdullah International Medical Research Center (KAIMRC), Gulf Cooperation Council (GCC) Infection Control Center Group and the World Health Organization-International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC-WHO) MERS-CoV Working Group. It was approved in June 2014 by the Ministry of the National Guard Health Affairs Institutional Review Board (IRB). A data safety monitoring board (DSMB) was formulated. The study is registered at http://www.clinicaltrials.gov (NCT02190799). </div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">26618098</PMID><DateCompleted><Year>2015</Year><Month>11</Month><Day>30</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">2193-1801</ISSN><JournalIssue CitedMedium="Print"><Volume>4</Volume><PubDate><Year>2015</Year></PubDate></JournalIssue><Title>SpringerPlus</Title><ISOAbbreviation>Springerplus</ISOAbbreviation></Journal><ArticleTitle>Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol.</ArticleTitle><Pagination><MedlinePgn>709</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s40064-015-1490-9</ELocationID><Abstract><AbstractText>As of September 30, 2015, a total of 1589 laboratory-confirmed cases of infection with the Middle East respiratory syndrome coronavirus (MERS-CoV) have been reported to the World Health Organization (WHO). At present there is no effective specific therapy against MERS-CoV. The use of convalescent plasma (CP) has been suggested as a potential therapy based on existing evidence from other viral infections. We aim to study the feasibility of CP therapy as well as its safety and clinical and laboratory effects in critically ill patients with MERS-CoV infection. We will also examine the pharmacokinetics of the MERS-CoV antibody response and viral load over the course of MERS-CoV infection. This study will inform a future randomized controlled trial that will examine the efficacy of CP therapy for MERS-CoV infection. In the CP collection phase, potential donors will be tested by the enzyme linked immunosorbent assay (ELISA) and the indirect fluorescent antibody (IFA) techniques for the presence of anti-MERS-CoV antibodies. Subjects with anti-MERS-CoV IFA titer of ≥1:160 and no clinical or laboratory evidence of MERS-CoV infection will be screened for eligibility for plasma donation according to standard donation criteria. In the CP therapy phase, 20 consecutive critically ill patients admitted to intensive care unit with laboratory-confirmed MERS-CoV infection will be enrolled and each will receive 2 units of CP. Post enrollment, patients will be followed for clinical and laboratory outcomes that include anti-MERS-CoV antibodies and viral load. This protocol was developed collaboratively by King Abdullah International Medical Research Center (KAIMRC), Gulf Cooperation Council (GCC) Infection Control Center Group and the World Health Organization-International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC-WHO) MERS-CoV Working Group. It was approved in June 2014 by the Ministry of the National Guard Health Affairs Institutional Review Board (IRB). A data safety monitoring board (DSMB) was formulated. The study is registered at http://www.clinicaltrials.gov (NCT02190799). </AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Arabi</LastName><ForeName>Yaseen</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Balkhy</LastName><ForeName>Hanan</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Infection Control Department, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hajeer</LastName><ForeName>Ali H</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bouchama</LastName><ForeName>Abderrezak</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hayden</LastName><ForeName>Frederick G</ForeName><Initials>FG</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Omari</LastName><ForeName>Awad</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Critical Care and Infection Control Department, Security Forces Hospital, AlFaisal University, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Hameed</LastName><ForeName>Fahad M</ForeName><Initials>FM</Initials><AffiliationInfo><Affiliation>Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Taha</LastName><ForeName>Yusri</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Infectious Diseases, Department of Medicine, King Abdulaziz Medical City, Al-Ahsa, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shindo</LastName><ForeName>Nahoko</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Pandemic and Epidemic Diseases Department, World Health Organization, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Whitehead</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Merson</LastName><ForeName>Laura</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, Ward 1, District 5, Ho Chi Minh City, Vietnam.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>AlJohani</LastName><ForeName>Sameera</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Khairy</LastName><ForeName>Khalid</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carson</LastName><ForeName>Gail</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Luke</LastName><ForeName>Thomas C</ForeName><Initials>TC</Initials><AffiliationInfo><Affiliation>Viral and Rickettsial Diseases Department, Naval Medical Research Center, The Henry Jackson Foundation, 6720A Rockledge Drive #100, Bethesda, MD 20817 USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hensley</LastName><ForeName>Lisa</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Integrated Research Facility, National Institute of Allergy and Infectious Diseases, Frederick, MD USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Dawood</LastName><ForeName>Abdulaziz</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Qahtani</LastName><ForeName>Saad</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Intensive Care Department, Respiratory Services, College of Medicine, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, P.O. Box 22490, Riyadh, 11426 Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Modjarrad</LastName><ForeName>Kayvon</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910 USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sadat</LastName><ForeName>Musharaf</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rohde</LastName><ForeName>Gernot</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Respiratory Medicine, Maastricht University Medical Center, P. Debyelaan 25, 6202AZ Maastricht, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leport</LastName><ForeName>Catherine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>The French Infectious Disease Society, Universite Paris Diderot, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fowler</LastName><ForeName>Robert</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Department of Medicine and Institute of Health Policy Management and Evaluation, AMR Infection Control and Publications AIP/PED/HSE/HQ, University of Toronto, Toronto, Canada ; Department of Critical Care Medicine and Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT02190799</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>001</GrantID><Agency>World Health Organization</Agency><Country>International</Country></Grant><Grant><GrantID>089276</GrantID><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>11</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>Switzerland</Country><MedlineTA>Springerplus</MedlineTA><NlmUniqueID>101597967</NlmUniqueID><ISSNLinking>2193-1801</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Convalescent plasma</Keyword><Keyword MajorTopicYN="N">Genome</Keyword><Keyword MajorTopicYN="N">Intensive care</Keyword><Keyword MajorTopicYN="N">MERS-CoV</Keyword><Keyword MajorTopicYN="N">Middle east respiratory syndrome coronavirus</Keyword><Keyword MajorTopicYN="N">Neutralizing antibodies</Keyword><Keyword MajorTopicYN="N">Serology</Keyword><Keyword MajorTopicYN="N">Viral pneumonia</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>04</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>10</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26618098</ArticleId><ArticleId IdType="doi">10.1186/s40064-015-1490-9</ArticleId><ArticleId IdType="pii">1490</ArticleId><ArticleId IdType="pmc">PMC4653124</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Ann Intern Med. 2006 Oct 17;145(8):599-609</Citation><ArticleIdList><ArticleId IdType="pubmed">16940336</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2012 Nov 8;367 (19):1814-20</Citation><ArticleIdList><ArticleId IdType="pubmed">23075143</ArticleId></ArticleIdList></Reference><Reference><Citation>Hong Kong Med J. 2006 Dec;12(6):489</Citation><ArticleIdList><ArticleId IdType="pubmed">17148811</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Infect Dis. 2011 Feb 15;52(4):447-56</Citation><ArticleIdList><ArticleId IdType="pubmed">21248066</ArticleId></ArticleIdList></Reference><Reference><Citation>Chest. 2013 Aug;144(2):464-73</Citation><ArticleIdList><ArticleId IdType="pubmed">23450336</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2014 Aug 28;371(9):828-35</Citation><ArticleIdList><ArticleId IdType="pubmed">25162889</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6</Citation><ArticleIdList><ArticleId IdType="pubmed">15616839</ArticleId></ArticleIdList></Reference><Reference><Citation>J Infect Dis. 2015 Jan 1;211(1):80-90</Citation><ArticleIdList><ArticleId IdType="pubmed">25030060</ArticleId></ArticleIdList></Reference><Reference><Citation>J Antimicrob Chemother. 2005 Nov;56(5):919-22</Citation><ArticleIdList><ArticleId IdType="pubmed">16183666</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet Infect Dis. 2015 May;15(5):559-64</Citation><ArticleIdList><ArticleId IdType="pubmed">25863564</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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