Evidence map›Paper›PMID 34855624›Full record

Trial reportJCI insight2022

Pharmacokinetics of high-titer anti-SARS-CoV-2 human convalescent plasma in high-risk children.

Oren Gordon, Mary Katherine Brosnan, Steve Yoon, Dawoon Jung, Kirsten Littlefield, Abhinaya Ganesan, Christopher A Caputo, Maggie Li, William R Morgenlander, Stephanie N Henson and 20 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in JCI insight, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04377672 (Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04377672 phase1completednot on this map

Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2

TypeinterventionalSponsorJohns Hopkins UniversityRan2020 to 2021Enrolled14ConditionsSARS-CoV-2 InfectionArmsAnti-SARS-CoV-2 Human Convalescent Plasma
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Severity of SARS-CoV-2 infection in children with inborn errors of immunity (primary immunodeficiencies): a systematic review.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2023
    Article
  9. Coronavirus Disease 2019 Convalescent Plasma Utilization in the United States: Data From the National Inpatient Sample.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  10. Article
  11. Article
  12. Convalescent plasma in hospitalized pediatric and obstetric coronavirus disease 2019 (COVID-19) patients.Pediatrics international : official journal of the Japan Pediatric Society · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 4 institutions in 1 country.

Oren GordonDivision of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mary Katherine BrosnanDivision of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Steve YoonW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Dawoon JungCenter for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Kirsten LittlefieldW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Abhinaya GanesanW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Christopher A CaputoW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Maggie LiW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
William R MorgenlanderDivision of Immunology, Department of Pathology.
Stephanie N HensonDivision of Immunology, Department of Pathology.
Alvaro A OrdonezDivision of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Patricia De JesusDivision of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Elizabeth W TuckerDepartment of Anesthesiology and Critical Care Medicine.
Nadine Peart AkindeleDivision of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Zexu MaW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jo WilsonW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Camilo A Ruiz-BedoyaDivision of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
M Elizabeth M YoungerDivision of Immunology, Department of Pediatrics.
Evan M BlochDivision of Transfusion Medicine, Department of Pathology.
Shmuel ShohamDivision of Infectious Diseases, Department of Medicine, and.
David SullivanW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Aaron Ar TobianDivision of Transfusion Medicine, Department of Pathology.
Kenneth R CookeDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ben LarmanDivision of Immunology, Department of Pathology.
Jogarao Vs GobburuCenter for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Arturo CasadevallW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Andrew PekoszW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Howard M LedermanDivision of Immunology, Department of Pediatrics.
Sabra L KleinW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Sanjay K JainDivision of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Johns Hopkins University · USInstitute for Transfusion Medicine · USUniversity of Maryland, Baltimore · USOffice of Infectious Diseases · US

Funding

Medical Scientist Training ProgramT32GM136577 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI ANDREA L COX · 2020 to 2026
$13.4M
RESEARCH TRAINING IN PEDIATRIC ALLERGY &IMMUNOLOGYT32AI007007 · NIAID · JOHNS HOPKINS UNIVERSITY · PI ROBERT A WOOD · 1985 to 2026
$5.4M
Research Training in Pediatric Infectious DiseasesT32AI052071 · NIAID · JOHNS HOPKINS UNIVERSITY · PI AARON M MILSTONE · 2002 to 2026
$5.2M
Conjugate vaccines for prevention and treatment of cryptococcosis - COVID-19 Revision SupplementR01AI152078 · NIAID · JOHNS HOPKINS UNIVERSITY · PI CASADEVALL, ARTURO · 2020 to 2024
$5.1M
Institutional Training for PediatriciansT32HD044355 · NICHD · JOHNS HOPKINS UNIVERSITY · PI BRADY, TAMMY MCLOUGHLIN · 2003 to 2023
$4.1M
Preclinical modeling to study Tuberculous MeningitisR01AI145435 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JAIN, SANJAY · 2020 to 2024
$4.0M
Measuring Intralesional Drug Exposures in Cavitary TB using Noninvasive In Vivo PET ImagingR01AI153349 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JAIN, SANJAY · 2020 to 2024
$3.8M
Novel Imaging and host-directed therapy in pediatric CNS TBK08AI139371 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TUCKER, ELIZABETH WINANS · 2019 to 2023
$994k
NIAID NIH HHS K08 AI139371NIAID NIH HHS R01 AI145435NIAID NIH HHS R01 AI152078NIAID NIH HHS R01 AI153349NIAID NIH HHS T32 AI007007NIAID NIH HHS T32 AI052071NICHD NIH HHS T32 HD044355NIGMS NIH HHS T32 GM136577
6 · The paper itself

Abstract

BACKGROUNDWhile most children who contract COVID-19 experience mild disease, high-risk children with underlying conditions may develop severe disease, requiring interventions. Kinetics of antibodies transferred via COVID-19 convalescent plasma early in disease have not been characterized.METHODSIn this study, high-risk children were prospectively enrolled to receive high-titer COVID-19 convalescent plasma (>1:320 anti-spike IgG; Euroimmun). Passive transfer of antibodies and endogenous antibody production were serially evaluated for up to 2 months after transfusion. Commercial and research ELISA assays, virus neutralization assays, high-throughput phage-display assay utilizing a coronavirus epitope library, and pharmacokinetic analyses were performed.RESULTSFourteen high-risk children (median age, 7.5 years) received high-titer COVID-19 convalescent plasma, 9 children within 5 days (range, 2-7 days) of symptom onset and 5 children within 4 days (range, 3-5 days) after exposure to SARS-CoV-2. There were no serious adverse events related to transfusion. Antibodies against SARS-CoV-2 were transferred from the donor to the recipient, but antibody titers declined by 14-21 days, with a 15.1-day half-life for spike protein IgG. Donor plasma had significant neutralization capacity, which was transferred to the recipient. However, as early as 30 minutes after transfusion, recipient plasma neutralization titers were 6.2% (range, 5.9%-6.7%) of donor titers.CONCLUSIONConvalescent plasma transfused to high-risk children appears to be safe, with expected antibody kinetics, regardless of weight or age. However, current use of convalescent plasma in high-risk children achieves neutralizing capacity, which may protect against severe disease but is unlikely to provide lasting protection.Trial registrationClinicalTrials.gov NCT04377672.FundingThe state of Maryland, Bloomberg Philanthropies, and the NIH (grants R01-AI153349, R01-AI145435-A1, K08-AI139371-A1, and T32-AI052071).

Indexed as

PharmacokineticsAdolescentAntibodies, NeutralizingAntibodies, ViralChildChild, PreschoolCOVID-19COVID-19 SerotherapyFemaleHumansImmunization, PassiveInfantMaleRisk FactorsSARS-CoV-2Antibodies, NeutralizingAntibodies, ViralCOVID-19ImmunoglobulinsInfectious disease

Identifiers

PMID34855624
PMCPMC8855821
OpenAlexW3215297235

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.