How did we rapidly implement a convalescent plasma program?
ABSTRACT Since the beginning of the COVID‐19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID‐19 convalescent plasma program to support its use through the single‐patient emergency inve...
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Veröffentlicht in: | Transfusion (Philadelphia, Pa.) Pa.), 2020-07, Vol.60 (7), p.1348-1355 |
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creator | Budhai, Alexandra Wu, Annie A. Hall, Lucette Strauss, Donna Paradiso, Sarai Alberigo, Jill Hillyer, Christopher D. Jett, Betsy Tobian, Aaron A. R. Bloch, Evan M. Sachais, Bruce S. Shaz, Beth H. |
description | ABSTRACT
Since the beginning of the COVID‐19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID‐19 convalescent plasma program to support its use through the single‐patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse. |
doi_str_mv | 10.1111/trf.15910 |
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Since the beginning of the COVID‐19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID‐19 convalescent plasma program to support its use through the single‐patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse.</description><identifier>ISSN: 0041-1132</identifier><identifier>EISSN: 1537-2995</identifier><identifier>DOI: 10.1111/trf.15910</identifier><identifier>PMID: 32449169</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Antibodies ; Antibodies, Viral - blood ; Antibodies, Viral - therapeutic use ; Betacoronavirus ; Blood Component Transfusion ; Clinical trials ; Coronavirus Infections - blood ; Coronavirus Infections - epidemiology ; Coronavirus Infections - therapy ; COVID-19 ; How Do I? ; Humans ; Immunization, Passive ; Pandemics ; Patients ; Plasma ; Pneumonia, Viral - blood ; Pneumonia, Viral - epidemiology ; Pneumonia, Viral - therapy ; Public health ; Randomization ; Randomized Controlled Trials as Topic ; SARS-CoV-2</subject><ispartof>Transfusion (Philadelphia, Pa.), 2020-07, Vol.60 (7), p.1348-1355</ispartof><rights>2020 AABB</rights><rights>2020 AABB.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5090-413ac292035b7e0a3f05769ed4323e3630be3150e0d296b35eddaef02c5500773</citedby><cites>FETCH-LOGICAL-c5090-413ac292035b7e0a3f05769ed4323e3630be3150e0d296b35eddaef02c5500773</cites><orcidid>0000-0002-0517-3766 ; 0000-0001-8181-9517 ; 0000-0002-2270-4821</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Ftrf.15910$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Ftrf.15910$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,778,782,883,1414,27907,27908,45557,45558</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32449169$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Budhai, Alexandra</creatorcontrib><creatorcontrib>Wu, Annie A.</creatorcontrib><creatorcontrib>Hall, Lucette</creatorcontrib><creatorcontrib>Strauss, Donna</creatorcontrib><creatorcontrib>Paradiso, Sarai</creatorcontrib><creatorcontrib>Alberigo, Jill</creatorcontrib><creatorcontrib>Hillyer, Christopher D.</creatorcontrib><creatorcontrib>Jett, Betsy</creatorcontrib><creatorcontrib>Tobian, Aaron A. R.</creatorcontrib><creatorcontrib>Bloch, Evan M.</creatorcontrib><creatorcontrib>Sachais, Bruce S.</creatorcontrib><creatorcontrib>Shaz, Beth H.</creatorcontrib><title>How did we rapidly implement a convalescent plasma program?</title><title>Transfusion (Philadelphia, Pa.)</title><addtitle>Transfusion</addtitle><description>ABSTRACT
Since the beginning of the COVID‐19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID‐19 convalescent plasma program to support its use through the single‐patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse.</description><subject>Antibodies</subject><subject>Antibodies, Viral - blood</subject><subject>Antibodies, Viral - therapeutic use</subject><subject>Betacoronavirus</subject><subject>Blood Component Transfusion</subject><subject>Clinical trials</subject><subject>Coronavirus Infections - blood</subject><subject>Coronavirus Infections - epidemiology</subject><subject>Coronavirus Infections - therapy</subject><subject>COVID-19</subject><subject>How Do I?</subject><subject>Humans</subject><subject>Immunization, Passive</subject><subject>Pandemics</subject><subject>Patients</subject><subject>Plasma</subject><subject>Pneumonia, Viral - blood</subject><subject>Pneumonia, Viral - epidemiology</subject><subject>Pneumonia, Viral - therapy</subject><subject>Public health</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic</subject><subject>SARS-CoV-2</subject><issn>0041-1132</issn><issn>1537-2995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU1LxDAQhoMoun4c_ANS8KKH6iRpEoOgiPgFC4LoOWTbqVbSpia7LvvvzbqrqOBcwpCHh3d4CdmlcETTHI9DfUSFprBCBlRwlTOtxSoZABQ0p5SzDbIZ4ysAMA10nWxwVhSaSj0gp7d-mlVNlU0xC7ZvKjfLmrZ32GI3zmxW-u7dOozlfO2dja3N-uCfg23Pt8labV3EneW7RZ6urx4vb_Ph_c3d5cUwLwVoyAvKbck0Ay5GCsHyGoSSGquCM45cchghpwIQKqbliAusKos1sFIIAKX4FjlbePvJqMVqHiVYZ_rQtDbMjLeN-f3TNS_m2b8bxU64UjoJDpaC4N8mGMembdJFztkO_SQaVoAUstDAErr_B331k9Cl8xLFCimpVJCowwVVBh9jwPo7DAUzr8SkSsxnJYnd-5n-m_zqIAHHC2DaOJz9bzKPD9cL5QdblZRW</recordid><startdate>202007</startdate><enddate>202007</enddate><creator>Budhai, Alexandra</creator><creator>Wu, Annie A.</creator><creator>Hall, Lucette</creator><creator>Strauss, Donna</creator><creator>Paradiso, Sarai</creator><creator>Alberigo, Jill</creator><creator>Hillyer, Christopher D.</creator><creator>Jett, Betsy</creator><creator>Tobian, Aaron A. 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R. ; Bloch, Evan M. ; Sachais, Bruce S. ; Shaz, Beth H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5090-413ac292035b7e0a3f05769ed4323e3630be3150e0d296b35eddaef02c5500773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antibodies</topic><topic>Antibodies, Viral - blood</topic><topic>Antibodies, Viral - therapeutic use</topic><topic>Betacoronavirus</topic><topic>Blood Component Transfusion</topic><topic>Clinical trials</topic><topic>Coronavirus Infections - blood</topic><topic>Coronavirus Infections - epidemiology</topic><topic>Coronavirus Infections - therapy</topic><topic>COVID-19</topic><topic>How Do I?</topic><topic>Humans</topic><topic>Immunization, Passive</topic><topic>Pandemics</topic><topic>Patients</topic><topic>Plasma</topic><topic>Pneumonia, Viral - blood</topic><topic>Pneumonia, Viral - epidemiology</topic><topic>Pneumonia, Viral - therapy</topic><topic>Public health</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic</topic><topic>SARS-CoV-2</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Budhai, Alexandra</creatorcontrib><creatorcontrib>Wu, Annie A.</creatorcontrib><creatorcontrib>Hall, Lucette</creatorcontrib><creatorcontrib>Strauss, Donna</creatorcontrib><creatorcontrib>Paradiso, Sarai</creatorcontrib><creatorcontrib>Alberigo, Jill</creatorcontrib><creatorcontrib>Hillyer, Christopher D.</creatorcontrib><creatorcontrib>Jett, Betsy</creatorcontrib><creatorcontrib>Tobian, Aaron A. 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Since the beginning of the COVID‐19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID‐19 convalescent plasma program to support its use through the single‐patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse.</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>32449169</pmid><doi>10.1111/trf.15910</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-0517-3766</orcidid><orcidid>https://orcid.org/0000-0001-8181-9517</orcidid><orcidid>https://orcid.org/0000-0002-2270-4821</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Antibodies Antibodies, Viral - blood Antibodies, Viral - therapeutic use Betacoronavirus Blood Component Transfusion Clinical trials Coronavirus Infections - blood Coronavirus Infections - epidemiology Coronavirus Infections - therapy COVID-19 How Do I? Humans Immunization, Passive Pandemics Patients Plasma Pneumonia, Viral - blood Pneumonia, Viral - epidemiology Pneumonia, Viral - therapy Public health Randomization Randomized Controlled Trials as Topic SARS-CoV-2 |
title | How did we rapidly implement a convalescent plasma program? |
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