Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. (Record no. 14293)

MARC details
000 -LEADER
fixed length control field 05285nam a22006617a 4500
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fixed length control field 240723s20242024 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 2379-3708
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 178460 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 38483534
245 ## - TITLE STATEMENT
Title Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial.
251 ## - Source
Source Jci Insight. 9(8), 2024 Mar 14.
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Abbreviated source JCI insight. 9(8), 2024 Mar 14.
253 ## - Journal Name
Journal name JCI insight
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2024
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Publication date 2024 Mar 14
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Manufacturer FY2024
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Publication status epublish
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Medline status MEDLINE
520 ## - SUMMARY, ETC.
Abstract BACKGROUNDCOVID-19 convalescent plasma (CCP) virus-specific antibody levels that translate into recipient posttransfusion antibody levels sufficient to prevent disease progression are not defined. METHODS This secondary analysis correlated donor and recipient antibody levels to hospitalization risk among unvaccinated, seronegative CCP recipients within the outpatient, double-blind, randomized clinical trial that compared CCP to control plasma. The majority of COVID-19 CCP arm hospitalizations (15/17, 88%) occurred in this unvaccinated, seronegative subgroup. A functional cutoff to delineate recipient high versus low posttransfusion antibody levels was established by 2 methods: (i) analyzing virus neutralization-equivalent anti-Spike receptor-binding domain immunoglobulin G (anti-S-RBD IgG) responses in donors or (ii) receiver operating characteristic (ROC) curve analysis. RESULTS SARS-CoV-2 anti-S-RBD IgG antibody was volume diluted 21.3-fold into posttransfusion seronegative recipients from matched donor units. Virus-specific antibody delivered was approximately 1.2 mg. The high-antibody recipients transfused early (symptom onset within 5 days) had no hospitalizations. A CCP-recipient analysis for antibody thresholds correlated to reduced hospitalizations found a statistical significant association between early transfusion and high antibodies versus all other CCP recipients (or control plasma), with antibody cutoffs established by both methods-donor-based virus neutralization cutoffs in posttransfusion recipients (0/85 [0%] versus 15/276 [5.6%]; P = 0.03) or ROC-based cutoff (0/94 [0%] versus 15/267 [5.4%]; P = 0.01). CONCLUSION In unvaccinated, seronegative CCP recipients, early transfusion of plasma units in the upper 30% of study donors' antibody levels reduced outpatient hospitalizations. High antibody level plasma units, given early, should be reserved for therapeutic use.TRIAL REGISTRATIONClinicalTrials.gov NCT04373460.FUNDINGDepartment of Defense (W911QY2090012); Defense Health Agency; Bloomberg Philanthropies; the State of Maryland; NIH (3R01AI152078-01S1, U24TR001609-S3, 1K23HL151826NIH); the Mental Wellness Foundation; the Moriah Fund; Octapharma; the Healthnetwork Foundation; the Shear Family Foundation; the NorthShore Research Institute; and the Rice Foundation.
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Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Antibodies, Viral
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Topical term or geographic name entry element *COVID-19
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Topical term or geographic name entry element *COVID-19 Serotherapy
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Topical term or geographic name entry element *Hospitalization
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Topical term or geographic name entry element *Immunization, Passive
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Topical term or geographic name entry element *SARS-CoV-2
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Topical term or geographic name entry element Adult
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Topical term or geographic name entry element Aged
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Topical term or geographic name entry element Antibodies, Neutralizing/bl [Blood]
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Topical term or geographic name entry element Antibodies, Neutralizing/im [Immunology]
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Topical term or geographic name entry element Antibodies, Viral/bl [Blood]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Antibodies, Viral/im [Immunology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Blood Donors/sn [Statistics & Numerical Data]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element COVID-19/im [Immunology]
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Topical term or geographic name entry element COVID-19/th [Therapy]
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Topical term or geographic name entry element Double-Blind Method
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Topical term or geographic name entry element Female
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Topical term or geographic name entry element Hospitalization/sn [Statistics & Numerical Data]
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Topical term or geographic name entry element Humans
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Topical term or geographic name entry element Immunization, Passive/mt [Methods]
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Topical term or geographic name entry element Immunoglobulin G/bl [Blood]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Immunoglobulin G/im [Immunology]
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Topical term or geographic name entry element Male
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Topical term or geographic name entry element Middle Aged
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Topical term or geographic name entry element Outpatients
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Topical term or geographic name entry element SARS-CoV-2/im [Immunology]
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Indexing Automated
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Institution Washington Cancer Institute
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Medline publication type Journal Article
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Medline publication type Randomized Controlled Trial
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Medline publication type Research Support, N.I.H., Extramural
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Medline publication type Research Support, Non-U.S. Gov't
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Shenoy, Aarthi
Institution Code WCI
790 ## - Authors
All authors Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AA, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ
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DOI <a href="https://dx.doi.org/10.1172/jci.insight.178460">https://dx.doi.org/10.1172/jci.insight.178460</a>
Public note https://dx.doi.org/10.1172/jci.insight.178460
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
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              07/23/2024   38483534 38483534 07/23/2024 07/23/2024 Journal Article

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