Your browser doesn't support javascript.
loading
Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial.
Park, Han-Sol; Yin, Anna; Barranta, Caelan; Lee, John S; Caputo, Christopher A; Sachithanandham, Jaiprasath; Li, Maggie; Yoon, Steve; Sitaras, Ioannis; Jedlicka, Anne; Eby, Yolanda; Ram, Malathi; Fernandez, Reinaldo E; Baker, Owen R; Shenoy, Aarthi G; Mosnaim, Giselle S; Fukuta, Yuriko; Patel, Bela; Heath, Sonya L; Levine, Adam C; Meisenberg, Barry R; Spivak, Emily S; Anjan, Shweta; Huaman, Moises A; Blair, Janis E; Currier, Judith S; Paxton, James H; Gerber, Jonathan M; Petrini, Joann R; Broderick, Patrick B; Rausch, William; Cordisco, Marie Elena; Hammel, Jean; Greenblatt, Benjamin; Cluzet, Valerie C; Cruser, Daniel; Oei, Kevin; Abinante, Matthew; Hammitt, Laura L; Sutcliffe, Catherine G; Forthal, Donald N; Zand, Martin S; Cachay, Edward R; Raval, Jay S; Kassaye, Seble G; Marshall, Christi E; Yarava, Anusha; Lane, Karen; McBee, Nichol A; Gawad, Amy L.
Afiliação
  • Park HS; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Yin A; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Barranta C; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Lee JS; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Caputo CA; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Sachithanandham J; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Li M; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Yoon S; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Sitaras I; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Jedlicka A; W. Harry Feinstone Department of Molecular Microbiology and Immunology; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Eby Y; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Ram M; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Fernandez RE; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Baker OR; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, 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, IL, USA.
  • Fukuta Y; Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX, USA.
  • Patel B; Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, TX, USA.
  • Heath SL; Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA.
  • Levine AC; Department of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, RI, USA.
  • Meisenberg BR; Luminis Health, Annapolis, MD, USA.
  • Spivak ES; Department of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, UT, USA.
  • Anjan S; Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.
  • Huaman MA; Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, OH, USA.
  • Blair JE; Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ, USA.
  • Currier JS; Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, CA, USA.
  • Paxton JH; Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI, USA.
  • Gerber JM; Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Petrini JR; Nuvance Health, Danbury, CT, USA.
  • Broderick PB; Nuvance Health Danbury Hospital, Danbury, CT, USA.
  • Rausch W; Nuvance Health, Danbury, CT, USA.
  • Cordisco ME; Nuvance Health, Danbury, CT, USA.
  • Hammel J; Nuvance Health Norwalk Hospital, Norwalk, CT, USA.
  • Greenblatt B; Nuvance Health Norwalk Hospital, Norwalk, CT, USA.
  • Cluzet VC; Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, NY, USA.
  • Cruser D; Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, NY, USA.
  • Oei K; Ascada Research, Fullerton, CA, USA.
  • Abinante M; Ascada Research, Fullerton, CA, USA.
  • Hammitt LL; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Sutcliffe CG; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Forthal DN; Department of Medicine, Division of Infectious Diseases, University of California, Irvine, CA, USA.
  • Zand MS; Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA.
  • Cachay ER; Department of Medicine, Division of Infectious Diseases, University of California, San Diego, CA, USA.
  • Raval JS; Department of Pathology, University of New Mexico School of Medicine, Albuquerque, NM, 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, MD, USA.
  • Yarava A; Department of Neurology, Brain Injury Outcomes, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Lane K; Department of Neurology, Brain Injury Outcomes, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • McBee NA; Department of Neurology, Brain Injury Outcomes, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Gawad AL; Department of Neurology, Brain Injury Outcomes, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
medRxiv ; 2023 Dec 15.
Article em En | MEDLINE | ID: mdl-37131659
ABSTRACT

BACKGROUND:

The COVID-19 convalescent plasma (CCP) viral specific antibody levels that translate into recipient post-transfusion antibody levels sufficient to prevent disease progression is 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 post-transfusion antibody levels was established by two

methods:

1) analyzing virus neutralization-equivalent anti-S-RBD IgG responses in donors or 2) receiver operating characteristic (ROC) analysis.

RESULTS:

SARS-CoV-2 anti-S-RBD IgG antibody was diluted by a factor of 21.3 into post-transfusion seronegative recipients from matched donor units. Viral specific antibody delivered approximated 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 significant association with Fisher's exact test between early and high antibodies versus all other CCP recipients (or control plasma) with antibody cutoffs established by both methods-donor virus neutralization-based cutoff (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 corresponding to the upper 30% of all study donors reduced outpatient hospitalizations. These high antibody level plasma units, given early, should be reserved for therapeutic use.Trial registration NCT04373460.

FUNDING:

Defense Health Agency and others.
Palavras-chave
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Risk_factors_studies Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Risk_factors_studies Idioma: En Ano de publicação: 2023 Tipo de documento: Article