Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol

doi:10.1186/s40064-015-1490-9

. 2015 Nov 19:4:709.

doi: 10.1186/s40064-015-1490-9. eCollection 2015.

Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol

Yaseen Arabi¹, Hanan Balkhy², Ali H Hajeer³, Abderrezak Bouchama¹, Frederick G Hayden⁴, Awad Al-Omari⁵, Fahad M Al-Hameed⁶, Yusri Taha⁷, Nahoko Shindo⁸, John Whitehead⁹, Laura Merson¹⁰, Sameera AlJohani³, Khalid Al-Khairy³, Gail Carson¹¹, Thomas C Luke¹², Lisa Hensley¹³, Abdulaziz Al-Dawood¹, Saad Al-Qahtani¹, Kayvon Modjarrad¹⁴, Musharaf Sadat¹⁵, Gernot Rohde¹⁶, Catherine Leport¹⁷, Robert Fowler¹⁸

Affiliations

¹ 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.
² Infection Control Department, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
³ Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
⁴ Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA USA.
⁵ Critical Care and Infection Control Department, Security Forces Hospital, AlFaisal University, Riyadh, Saudi Arabia.
⁶ Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia.
⁷ Infectious Diseases, Department of Medicine, King Abdulaziz Medical City, Al-Ahsa, Saudi Arabia.
⁸ Pandemic and Epidemic Diseases Department, World Health Organization, Geneva, Switzerland.
⁹ Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.
¹⁰ Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, Ward 1, District 5, Ho Chi Minh City, Vietnam.
¹¹ University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE UK.
¹² Viral and Rickettsial Diseases Department, Naval Medical Research Center, The Henry Jackson Foundation, 6720A Rockledge Drive #100, Bethesda, MD 20817 USA.
¹³ Integrated Research Facility, National Institute of Allergy and Infectious Diseases, Frederick, MD USA.
¹⁴ U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910 USA.
¹⁵ Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
¹⁶ Department of Respiratory Medicine, Maastricht University Medical Center, P. Debyelaan 25, 6202AZ Maastricht, The Netherlands.
¹⁷ The French Infectious Disease Society, Universite Paris Diderot, Paris, France.
¹⁸ 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.

PMID: 26618098
PMCID: PMC4653124
DOI: 10.1186/s40064-015-1490-9

Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol

Yaseen Arabi et al. Springerplus. 2015.

. 2015 Nov 19:4:709.

doi: 10.1186/s40064-015-1490-9. eCollection 2015.

Authors

Affiliations

¹ 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.
² Infection Control Department, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
³ Pathology and Laboratory Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
⁴ Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA USA.
⁵ Critical Care and Infection Control Department, Security Forces Hospital, AlFaisal University, Riyadh, Saudi Arabia.
⁶ Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Jeddah, Saudi Arabia.
⁷ Infectious Diseases, Department of Medicine, King Abdulaziz Medical City, Al-Ahsa, Saudi Arabia.
⁸ Pandemic and Epidemic Diseases Department, World Health Organization, Geneva, Switzerland.
⁹ Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.
¹⁰ Oxford University Clinical Research Unit, 764 Vo Van Kiet Street, Ward 1, District 5, Ho Chi Minh City, Vietnam.
¹¹ University of Oxford Centre for Tropical Medicine (CCVTM), Churchill Hospital Old Road, Headington, Oxford, OX3 7LE UK.
¹² Viral and Rickettsial Diseases Department, Naval Medical Research Center, The Henry Jackson Foundation, 6720A Rockledge Drive #100, Bethesda, MD 20817 USA.
¹³ Integrated Research Facility, National Institute of Allergy and Infectious Diseases, Frederick, MD USA.
¹⁴ U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910 USA.
¹⁵ Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
¹⁶ Department of Respiratory Medicine, Maastricht University Medical Center, P. Debyelaan 25, 6202AZ Maastricht, The Netherlands.
¹⁷ The French Infectious Disease Society, Universite Paris Diderot, Paris, France.
¹⁸ 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.

PMID: 26618098
PMCID: PMC4653124
DOI: 10.1186/s40064-015-1490-9

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).

Keywords: Convalescent plasma; Genome; Intensive care; MERS-CoV; Middle east respiratory syndrome coronavirus; Neutralizing antibodies; Serology; Viral pneumonia.

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References

1. Cheng Y, Wong R, Soo YO, et al. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005;24:44–46. doi: 10.1007/s10096-004-1271-9. - DOI - PMC - PubMed
1. Clopper CJ, Pearson ES. the use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404–413. doi: 10.1093/biomet/26.4.404. - DOI
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1. Hung IF, To KK, Lee CK, et al. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011;52:447–456. doi: 10.1093/cid/ciq106. - DOI - PMC - PubMed
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[1] Cheng Y, Wong R, Soo YO, et al. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005;24:44–46. doi: 10.1007/s10096-004-1271-9. - DOI - PMC - PubMed

[2] Cheng Y, Wong R, Soo YO, et al. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005;24:44–46. doi: 10.1007/s10096-004-1271-9. - DOI - PMC - PubMed

[3] Clopper CJ, Pearson ES. the use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404–413. doi: 10.1093/biomet/26.4.404. - DOI

[4] Clopper CJ, Pearson ES. the use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404–413. doi: 10.1093/biomet/26.4.404. - DOI

[5] Drosten C, Meyer B, Muller MA, et al. Transmission of MERS-coronavirus in household contacts. N Engl J Med. 2014;371:828–835. doi: 10.1056/NEJMoa1405858. - DOI - PubMed

[6] Drosten C, Meyer B, Muller MA, et al. Transmission of MERS-coronavirus in household contacts. N Engl J Med. 2014;371:828–835. doi: 10.1056/NEJMoa1405858. - DOI - PubMed

[7] Hung IF, To KK, Lee CK, et al. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011;52:447–456. doi: 10.1093/cid/ciq106. - DOI - PMC - PubMed

[8] Hung IF, To KK, Lee CK, et al. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011;52:447–456. doi: 10.1093/cid/ciq106. - DOI - PMC - PubMed

[9] Hung IF, To KK, Lee CK, et al. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection. Chest. 2013;144:464–473. doi: 10.1378/chest.12-2907. - DOI - PubMed

[10] Hung IF, To KK, Lee CK, et al. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection. Chest. 2013;144:464–473. doi: 10.1378/chest.12-2907. - DOI - PubMed

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Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol

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Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol

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