Arwa Z Al-Riyami1, Richard Schäfer2, Karin van den Berg3,4, Evan M Bloch5, Lise J Estcourt6, Ruchika Goel7,8, Salwa Hindawi9, Cassandra D Josephson10,11, Kevin Land12,13, Zoe K McQuilten14,15, Steven L Spitalnik16, Erica M Wood14,15, Dana V Devine17,18, Cynthia So-Osman19,20. 1. Department of Haematology, Sultan Qaboos University Hospital, Muscat, Sultanate of Oman. 2. Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Goethe University Hospital, Frankfurt am Main, Germany. 3. Medical Division, Translational Research Department, South African National Blood Service, Port Elizabeth, South Africa. 4. Division Clinical Haematology, Department of Medicine, University of Cape Town, Cape Town, South Africa. 5. Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 6. Radcliffe Department of Medicine, University of Oxford and NHS Blood and Transplant, Oxford, UK. 7. Division of Transfusion Medicine, Department of Pathology, Johns Hopkins Hospital, Baltimore, MD, USA. 8. Division of Hematology/Oncology, Simmons Cancer Institute at SIU School of Medicine and Mississippi Valley Regional Blood Center, Springfield, IL, USA. 9. Haematology Department, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia. 10. Department of Pathology and Laboratory Medicine, Center for Transfusion and Cellular Therapies, Emory University School of Medicine, Atlanta, GE, USA. 11. Department of Pediatrics, Aflac Cancer Center and Blood Disorders, Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GE, USA. 12. Corporate Medical Affairs, Vitalant, Phoenix, AZ, USA. 13. Department of Pathology, UT Health Science San Antonio, San Antonio, TX, USA. 14. Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia. 15. Department of Clinical Haematology, Monash Health, Melbourne, VIC, Australia. 16. Department of Pathology & Cell Biology, Columbia University, New York, NY, USA. 17. Canadian Blood Services, Vancouver, BC, Canada. 18. Department of Pathology & Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada. 19. Department Unit Transfusion Medicine, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands. 20. Department Haematology, Erasmus Medical Center, Rotterdam, The Netherlands.
Abstract
BACKGROUND AND OBJECTIVES: Use of convalescent plasma for coronavirus disease 2019 (COVID-19) treatment has gained interest worldwide. However, there is lack of evidence on its dosing, safety and effectiveness. Until data from clinical studies are available to provide solid evidence for worldwide applicable guidelines, there is a need to provide guidance to the transfusion community and researchers on this emergent therapeutic option. This paper aims to identify existing key gaps in current knowledge in the clinical application of COVID-19 convalescent plasma (CCP). MATERIALS AND METHODS: The International Society of Blood Transfusion (ISBT) initiated a multidisciplinary working group with worldwide representation from all six continents with the aim of reviewing existing practices on CCP use from donor, product and patient perspectives. A subgroup of clinical transfusion professionals was formed to draft a document for CCP clinical application to identify the gaps in knowledge in existing literature. RESULTS: Gaps in knowledge were identified in the following main domains: study design, patient eligibility, CCP dose, frequency and timing of CCP administration, parameters to assess response to CCP treatment and long-term outcome, adverse events and CCP application in less-resourced countries as well as in paediatrics and neonates. CONCLUSION: This paper outlines a framework of gaps in the knowledge of clinical deployment of CPP that were identified as being most relevant. Studies to address the identified gaps are required to provide better evidence on the effectiveness and safety of CCP use.
BACKGROUND AND OBJECTIVES: Use of convalescent plasma for coronavirus disease 2019 (COVID-19) treatment has gained interest worldwide. However, there is lack of evidence on its dosing, safety and effectiveness. Until data from clinical studies are available to provide solid evidence for worldwide applicable guidelines, there is a need to provide guidance to the transfusion community and researchers on this emergent therapeutic option. This paper aims to identify existing key gaps in current knowledge in the clinical application of COVID-19 convalescent plasma (CCP). MATERIALS AND METHODS: The International Society of Blood Transfusion (ISBT) initiated a multidisciplinary working group with worldwide representation from all six continents with the aim of reviewing existing practices on CCP use from donor, product and patient perspectives. A subgroup of clinical transfusion professionals was formed to draft a document for CCP clinical application to identify the gaps in knowledge in existing literature. RESULTS: Gaps in knowledge were identified in the following main domains: study design, patient eligibility, CCP dose, frequency and timing of CCP administration, parameters to assess response to CCP treatment and long-term outcome, adverse events and CCP application in less-resourced countries as well as in paediatrics and neonates. CONCLUSION: This paper outlines a framework of gaps in the knowledge of clinical deployment of CPP that were identified as being most relevant. Studies to address the identified gaps are required to provide better evidence on the effectiveness and safety of CCP use.
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