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Early administration of COVID-19 convalescent plasma with high titer antibody content by live viral neutralization assay is associated with modest clinical efficacy.
Belov, Artur; Huang, Yin; Villa, Carlos H; Whitaker, Barbee I; Forshee, Richard; Anderson, Steven A; Eder, Anne; Verdun, Nicole; Joyner, Michael J; Wright, Scott R; Carter, Rickey E; Hung, Deborah T; Homer, Mary; Hoffman, Corey; Lauer, Michael; Marks, Peter.
  • Belov A; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Huang Y; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Villa CH; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Whitaker BI; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Forshee R; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Anderson SA; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Eder A; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Verdun N; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
  • Joyner MJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, USA.
  • Wright SR; Department of Cardiology and the Human Research Protection Program, Mayo Clinic, Rochester, Minnesota, USA.
  • Carter RE; Department of Quantitative Health Sciences, Mayo Clinic, Jacksonville, Florida, USA.
  • Hung DT; Infectious Disease and Microbiome Program, Broad Institute, Cambridge, Massachusetts, USA.
  • Homer M; Biomedical Advanced Research and Development Authority (BARDA), District of Columbia, Washington, USA.
  • Hoffman C; Biomedical Advanced Research and Development Authority (BARDA), District of Columbia, Washington, USA.
  • Lauer M; Office of the Director, National Institutes of Health, Bethesda, Maryland, USA.
  • Marks P; Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Am J Hematol ; 97(6): 770-779, 2022 06 01.
Article in English | MEDLINE | ID: covidwho-1750295
ABSTRACT
The efficacy of COVID-19 convalescent plasma (CCP) as a treatment for hospitalized patients with COVID-19 remains somewhat controversial; however, many studies have not evaluated CCP documented to have high neutralizing antibody titer by a highly accurate assay. To evaluate the correlation of the administration of CCP with titer determined by a live viral neutralization assay with 7- and 28-day death rates during hospitalization, a total of 23 118 patients receiving a single unit of CCP were stratified into two groups those receiving high titer CCP (>250 50% inhibitory dilution, ID50; n = 13 636) or low titer CCP (≤250 ID50; n = 9482). Multivariable Cox regression was performed to assess risk factors. Non-intubated patients who were transfused with high titer CCP showed 1.1% and 1.7% absolute reductions in overall 7- and 28-day death rates, respectively, compared to those non-intubated patients receiving low titer CCP. No benefit of CCP was observed in intubated patients. The relative benefit of high titer CCP was confirmed in multivariable Cox regression. Administration of CCP with high titer antibody content determined by live viral neutralization assay to non-intubated patients is associated with modest clinical efficacy. Although shown to be only of modest clinical benefit, CCP may play a role in the future should viral variants develop that are not neutralized by other available therapeutics.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Variants Limits: Humans Language: English Journal: Am J Hematol Year: 2022 Document Type: Article Affiliation country: Ajh.26531

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Variants Limits: Humans Language: English Journal: Am J Hematol Year: 2022 Document Type: Article Affiliation country: Ajh.26531