Trial reportJCI insight2024
Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial.
Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph
Trial report in JCI insight, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04373460 (Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.
0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% of its field
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.
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.
Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Timing, Titre, and Host Determinants of Convalescent Plasma Efficacy in COVID-19: A Systematic Review With Design-Stratified Narrative Synthesis.Reviews in medical virology · 2026Pooled it
- The effect of early COVID-19 treatment with convalescent plasma on antibody responses to SARS-CoV-2.Microbiology spectrum · 2025Trial
- Patient and donor antibody profiles in early COVID-19 convalescent plasma therapy in the COnV-ert trial.Frontiers in immunology · 2025Trial
- Adapting antibody-invertase fusion protein immunoassays to multiwell plates for infectious disease antibody quantification.Sensors & diagnostics · 2026Article
- COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval.Expert review of anti-infective therapy · 2026Review
- Intelligent Patient Management in Viral Diseases: An Integrated Regression Model and Multi-Criteria Decision-Making Approach to Convalescent Plasma Transfusion.Healthcare (Basel, Switzerland) · 2025Article
- Article
- Estimates of actual and potential lives saved in the United States from the use of COVID-19 convalescent plasma.Proceedings of the National Academy of Sciences of the United States of America · 2024Article
- Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks.Journal of clinical and translational science · 2024Article
Corrections and comments
- Update of
Authors and funding
81 authors at 20 institutions in 1 country.
Han-Sol ParkW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Anna YinW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Caelan BarrantaW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
John S LeeW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Christopher A CaputoW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jaiprasath SachithanandhamW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Maggie LiW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Steve YoonW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Ioannis SitarasW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Anne JedlickaW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Yolanda EbyDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Malathi RamDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Reinaldo E FernandezDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Owen R BakerDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Aarthi G ShenoyDepartment of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center, Washington DC, USA.
Giselle S MosnaimDivision of Allergy and Immunology, Department of Medicine, NorthShore University Health System, Evanston, Illinois, USA.
Yuriko FukutaDepartment of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA.
Bela PatelDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, Texas, USA.
Sonya L HeathDepartment of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Adam C LevineDepartment of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, Rhode Island, USA.
Barry R MeisenbergLuminis Health, Annapolis, Maryland, USA.
Emily S SpivakDepartment of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Shweta AnjanDepartment of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.
Moises A HuamanDepartment of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio, USA.
Janis E BlairDepartment of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, Arizona, USA.
Judith S CurrierDepartment of Medicine, Division of Infectious Diseases, UCLA, Los Angeles, California, USA.
James H PaxtonDepartment of Emergency Medicine, Wayne State University School of Medicine, Detroit, Michigan, USA.
Jonathan M GerberDepartment of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Joann R PetriniNuvance Health, Danbury, Connecticut, USA.
Patrick B BroderickNuvance Health Danbury Hospital, Danbury, Connecticut, USA.
William RauschNuvance Health, Danbury, Connecticut, USA.
Marie Elena CordiscoNuvance Health, Danbury, Connecticut, USA.
Jean HammelNuvance Health Norwalk Hospital, Norwalk, Connecticut, USA.
Benjamin GreenblattNuvance Health Norwalk Hospital, Norwalk, Connecticut, USA.
Valerie C CluzetNuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, USA.
Daniel CruserNuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, USA.
Kevin OeiAscada Research, Fullerton, California, USA.
Matthew AbinanteAscada Research, Fullerton, California, USA.
Laura L HammittDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Catherine G SutcliffeDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Donald N ForthalDepartment of Medicine, Division of Infectious Diseases, University of California, Irvine, California, USA.
Martin S ZandDepartment of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Edward R CachayDepartment of Medicine, Division of Infectious Diseases, UCSD, San Diego, California, USA.
Jay S RavalDepartment of Pathology, University of New Mexico School of Medicine, Albuquerque, New Mexico, USA.
Seble G KassayeDepartment of Medicine, Division of Infectious Diseases, Georgetown University Medical Center, Washington DC, USA.
Christi E MarshallDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Anusha YaravaDepartment of Neurology, Brain Injury Outcomes.
Karen LaneDepartment of Neurology, Brain Injury Outcomes.
Nichol A McBeeDepartment of Neurology, Brain Injury Outcomes.
Amy L GawadDepartment of Neurology, Brain Injury Outcomes.
Nicky KarlenDepartment of Neurology, Brain Injury Outcomes.
Atika SinghDepartment of Neurology, Brain Injury Outcomes.
Daniel E FordInstitute for Clinical and Translational Research, and.
Douglas A JabsDepartment of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Lawrence J AppelWelch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
David M ShadeDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Bryan LauDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Stephan EhrhardtDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Sheriza N BakshDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Janna R ShapiroW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jiangda OuDepartment of Neurology, Brain Injury Outcomes.
Yu Bin NaDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Maria D KnollDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Elysse Ornelas-GatdulaChemistry-Biology Interface Program, Zanvyl Krieger School of Arts & Sciences, Johns Hopkins University, Baltimore, Maryland, USA.
Netzahualcoyotl Arroyo-CurrasChemistry-Biology Interface Program, Zanvyl Krieger School of Arts & Sciences, Johns Hopkins University, Baltimore, Maryland, USA.
Thomas J GniadekDepartment of Pathology and Laboratory Medicine, Northshore University Health System, Evanston, Illinois, USA.
Patrizio CaturegliDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Jinke WuAdvanced Mammalian Biomanufacturing Innovation Center, Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, Maryland, USA.
Nelson NdahiroAdvanced Mammalian Biomanufacturing Innovation Center, Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, Maryland, USA.
Michael J BetenbaughAdvanced Mammalian Biomanufacturing Innovation Center, Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, Maryland, USA.
Alyssa ZimanDepartment of Pathology and Laboratory Medicine, Wing-Kwai and Alice Lee-Tsing Chung Transfusion Service, David Geffen School of Medicine, UCLA, Los Angeles, California, USA.
Daniel F HanleyDepartment of Neurology, Brain Injury Outcomes.
Arturo CasadevallW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Shmuel ShohamDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Evan M BlochDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Kelly A GeboDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Aaron Ar TobianDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Oliver LaeyendeckerDivision of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAID), Baltimore, Maryland, USA.
Andrew PekoszW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Sabra L KleinW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
David J SullivanW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Johns Hopkins University · USBrain Injury Association of America · USNorthShore University HealthSystem · USNorwalk Hospital · USUniversity of California, Los Angeles · USVassar Brothers Medical Center · USBaylor College of Medicine · USDanbury Hospital · USGeorgetown University · USMayo Clinic Hospital · USMedStar Washington Hospital Center · USNational Institute of Allergy and Infectious Diseases · USRhode Island Hospital · USThe University of Texas Health Science Center at Houston · USUniversity of Alabama at Birmingham · USUniversity of California, Irvine · USUniversity of California San Diego · USUniversity of Cincinnati · USUniversity of Massachusetts Chan Medical School · USUniversity of Miami · US
Funding
Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8MJohns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3MThe University of Rochester's Clinical and Translational Science InstituteUL1TR002001 · NCATS · UNIVERSITY OF ROCHESTER · PI WILSON, KAREN M., ZAND, MARTIN S · 2016 to 2024
$34.6MCTSA UM1 Program at University of UtahUM1TR004409 · NCATS · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI RACHEL HESS, Jennifer Juhl Majersik · 2023 to 2026
$21.9MInternational Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8MJohns Hopkins HIV Epidemiology and Prevention Sciences Training ProgramT32AI102623 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Shruti H Mehta · 2013 to 2026
$5.3MConjugate vaccines for prevention and treatment of cryptococcosis - COVID-19 Revision SupplementR01AI152078 · NIAID · JOHNS HOPKINS UNIVERSITY · PI CASADEVALL, ARTURO · 2020 to 2024
$5.1MThe Chemistry-Biology Interface Program at Johns Hopkins UniversityT32GM149382 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI STEVEN E ROKITA · 2023 to 2026
$1.4MThe Malaria Transfusion Risk (MATRix) StudyK23HL151826 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI BLOCH, EVAN MARTIN · 2020 to 2024
$882kNCATS NIH HHS U24 TR001609NCATS NIH HHS UL1 TR001409NCATS NIH HHS UL1 TR002001NCATS NIH HHS UM1 TR004409NHLBI NIH HHS K23 HL151826NIAID NIH HHS R01 AI152078NIAID NIH HHS T32 AI102623NIGMS NIH HHS T32 GM149382
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.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.
Indexed as
Antibodies, ViralCOVID-19COVID-19 SerotherapyHospitalizationImmunization, PassiveSARS-CoV-2AdultAgedAntibodies, NeutralizingBlood DonorsDouble-Blind MethodFemaleHumansImmunoglobulin GMaleMiddle AgedAntibodies, NeutralizingAntibodies, ViralImmunoglobulin GCOVID-19ImmunoglobulinsImmunotherapy
Identifiers
What Socratic holds
Textmetadata
LicenceCC BY
Read underepoch 390
Registered trials
NCT04373460ClinicalTrials.gov
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 Socratic graph.