دورية أكاديمية
Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial.
العنوان: | Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. |
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المؤلفون: | Park HS; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Yin A; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Barranta C; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Lee JS; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Caputo CA; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Sachithanandham J; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Li M; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Yoon S; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Sitaras I; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Jedlicka A; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Eby Y; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Ram M; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Fernandez RE; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Baker OR; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Shenoy AG; Department of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center, Washington DC, USA., Mosnaim GS; Division of Allergy and Immunology, Department of Medicine, NorthShore University Health System, Evanston, Illinois, USA., Fukuta Y; Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA., Patel B; Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, Texas, USA., Heath SL; Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA., Levine AC; Department of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, Rhode Island, USA., Meisenberg BR; Luminis Health, Annapolis, Maryland, USA., Spivak ES; Department of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, Utah, USA., Anjan S; Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA., Huaman MA; Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio, USA., Blair JE; Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, Arizona, USA., Currier JS; Department of Medicine, Division of Infectious Diseases, UCLA, Los Angeles, California, USA., Paxton JH; Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, Michigan, USA., Gerber JM; Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA., Petrini JR; Nuvance Health, Danbury, Connecticut, USA., Broderick PB; Nuvance Health Danbury Hospital, Danbury, Connecticut, USA., Rausch W; Nuvance Health, Danbury, Connecticut, USA., Cordisco ME; Nuvance Health, Danbury, Connecticut, USA., Hammel J; Nuvance Health Norwalk Hospital, Norwalk, Connecticut, USA., Greenblatt B; Nuvance Health Norwalk Hospital, Norwalk, Connecticut, USA., Cluzet VC; Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, USA., Cruser D; Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, USA., Oei K; Ascada Research, Fullerton, California, USA., Abinante M; Ascada Research, Fullerton, California, USA., Hammitt LL; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Sutcliffe CG; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Forthal DN; Department of Medicine, Division of Infectious Diseases, University of California, Irvine, California, USA., Zand MS; Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA., Cachay ER; Department of Medicine, Division of Infectious Diseases, UCSD, San Diego, California, USA., Raval JS; Department of Pathology, University of New Mexico School of Medicine, Albuquerque, New Mexico, USA., Kassaye SG; Department of Medicine, Division of Infectious Diseases, Georgetown University Medical Center, Washington DC, USA., Marshall CE; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Yarava A; Department of Neurology, Brain Injury Outcomes., Lane K; Department of Neurology, Brain Injury Outcomes., McBee NA; Department of Neurology, Brain Injury Outcomes., Gawad AL; Department of Neurology, Brain Injury Outcomes., Karlen N; Department of Neurology, Brain Injury Outcomes., Singh A; Department of Neurology, Brain Injury Outcomes., Ford DE; Institute for Clinical and Translational Research, and., Jabs DA; Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Appel LJ; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Shade DM; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Lau B; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Ehrhardt S; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Baksh SN; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Shapiro JR; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Ou J; Department of Neurology, Brain Injury Outcomes., Na YB; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Knoll MD; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Ornelas-Gatdula E; Chemistry-Biology Interface Program, Zanvyl Krieger School of Arts & Sciences, Johns Hopkins University, Baltimore, Maryland, USA., Arroyo-Curras N; Chemistry-Biology Interface Program, Zanvyl Krieger School of Arts & Sciences, Johns Hopkins University, Baltimore, Maryland, USA.; Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Gniadek TJ; Department of Pathology and Laboratory Medicine, Northshore University Health System, Evanston, Illinois, USA., Caturegli P; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Wu J; Advanced Mammalian Biomanufacturing Innovation Center, Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, Maryland, USA., Ndahiro N; Advanced Mammalian Biomanufacturing Innovation Center, Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, Maryland, USA., Betenbaugh MJ; Advanced Mammalian Biomanufacturing Innovation Center, Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, Maryland, USA., Ziman A; Department of Pathology and Laboratory Medicine, Wing-Kwai and Alice Lee-Tsing Chung Transfusion Service, David Geffen School of Medicine, UCLA, Los Angeles, California, USA., Hanley DF; Department of Neurology, Brain Injury Outcomes., Casadevall A; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Shoham S; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Bloch EM; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Gebo KA; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Tobian AA; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Laeyendecker O; Division of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAID), Baltimore, Maryland, USA., Pekosz A; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Klein SL; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Sullivan DJ; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. |
المصدر: | JCI insight [JCI Insight] 2024 Mar 14; Vol. 9 (8). Date of Electronic Publication: 2024 Mar 14. |
نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
اللغة: | English |
بيانات الدورية: | Publisher: American Society for Clinical Investigation Country of Publication: United States NLM ID: 101676073 Publication Model: Electronic Cited Medium: Internet ISSN: 2379-3708 (Electronic) Linking ISSN: 23793708 NLM ISO Abbreviation: JCI Insight Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: Ann Arbor, Michigan : American Society for Clinical Investigation, [2016]- |
مواضيع طبية MeSH: | COVID-19*/immunology , COVID-19*/therapy , COVID-19 Serotherapy* , Antibodies, Viral*/blood , Antibodies, Viral*/immunology , Immunization, Passive*/methods , Hospitalization*/statistics & numerical data , SARS-CoV-2*/immunology, Humans ; Male ; Female ; Middle Aged ; Adult ; Immunoglobulin G/blood ; Immunoglobulin G/immunology ; Antibodies, Neutralizing/immunology ; Antibodies, Neutralizing/blood ; Double-Blind Method ; Aged ; Blood Donors/statistics & numerical data ; Outpatients |
مستخلص: | BACKGROUNDCOVID-19 convalescent plasma (CCP) virus-specific antibody levels that translate into recipient posttransfusion antibody levels sufficient to prevent disease progression are not defined.METHODSThis 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.RESULTSSARS-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).CONCLUSIONIn 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. |
التعليقات: | Update of: medRxiv. 2023 Dec 15;:. (PMID: 37131659) |
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معلومات مُعتمدة: | K23 HL151826 United States HL NHLBI NIH HHS; R01 AI152078 United States AI NIAID NIH HHS; U24 TR001609 United States TR NCATS NIH HHS; UL1 TR001409 United States TR NCATS NIH HHS |
فهرسة مساهمة: | Keywords: COVID-19; Immunoglobulins; Immunotherapy |
سلسلة جزيئية: | ClinicalTrials.gov NCT04373460 |
المشرفين على المادة: | 0 (Antibodies, Viral) 0 (Immunoglobulin G) 0 (Antibodies, Neutralizing) |
تواريخ الأحداث: | Date Created: 20240314 Date Completed: 20240423 Latest Revision: 20240603 |
رمز التحديث: | 20240603 |
مُعرف محوري في PubMed: | PMC11141865 |
DOI: | 10.1172/jci.insight.178460 |
PMID: | 38483534 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2379-3708 |
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DOI: | 10.1172/jci.insight.178460 |