Evidence map›Paper›PMID 35780813›Full record

Trial reportChest2022

Neutralizing COVID-19 Convalescent Plasma in Adults Hospitalized With COVID-19: A Blinded, Randomized, Placebo-Controlled Trial.

Wesley H Self, Allison P Wheeler, Thomas G Stewart, Harry Schrager, Jason Mallada, Christopher B Thomas, Vince D Cataldo, Hollis R O'Neal, Nathan I Shapiro, Conor Higgins and 42 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Chest, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04362176 (Passive Immunity Trial for Our Nation), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 7% 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.

NCT04362176 phase3completednot on this map

Passive Immunity Trial for Our Nation (PassItOn)

TypeinterventionalSponsorVanderbilt University Medical CenterRan2020 to 2021Enrolled974ConditionsCOVID-19, Coronavirus, SARS-CoV-2Armspathogen reduced SARS-CoV-2 convalescent plasma, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. A Randomized Controlled Study Assessing Convalescent Immunoglobulins vs Convalescent Plasma for Hospitalized Patients With Coronavirus 2019.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  5. Article
  6. Response to Letter to the Editor RegardingOpen forum infectious diseases · 2025
    Article
  7. Article
  8. Review
  9. Evidence for the Efficacy of COVID-19 Convalescent Plasma.Current topics in microbiology and immunology · 2025
    Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Progressing from "Whether to" to "How to" Conduct Pragmatic Trials.The American journal of bioethics : AJOB · 2023
    Article
  16. Article
  17. Article
  18. Article
  19. Response.Chest · 2022
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

52 authors at 20 institutions in 1 country.

Wesley H SelfVanderbilt Institute for Clinical and Translational Research and Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN. Electronic address: wesley.self@vumc.org.
Allison P WheelerDepartment of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, TN.
Thomas G StewartDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
Harry SchragerDepartment of Medicine, Tufts School of Medicine, Newton-Wellesley Hospital, Newton, MA.
Jason MalladaDepartment of Pharmacy, Newton-Wellesley Hospital, Massachusetts College of Pharmacy and Health Sciences, Newton, MA.
Christopher B ThomasDivision of Pulmonary and Critical Care, Louisiana State University Health-Sciences Center, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA.
Vince D CataldoDivision of Hematology and Oncology, Louisiana State University Health-Sciences Center, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA.
Hollis R O'NealDivision of Pulmonary and Critical Care, Louisiana State University Health-Sciences Center, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA.
Nathan I ShapiroDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
Conor HigginsDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
Adit A GindeDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO.
Lakshmi ChauhanDepartment of Medicine, University of Colorado School of Medicine, Aurora, CO.
Nicholas J JohnsonDepartment of Emergency Medicine and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, WA.
Daniel J HenningDepartment of Emergency Medicine, University of Washington, Seattle, WA.
Stuti J JaiswalDivision of Hospital Medicine, Scripps Clinic, Scripps Research Translational Institute, The Scripps Research Institute, La Jolla, CA.
Manoj J MammenDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, State University of New York at Buffalo, Buffalo, NY.
Estelle S HarrisDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Utah, Salt Lake City, UT.
Sonal R PannuDivision of Pulmonary, Critical Care, and Sleep Medicine, The Ohio State University, Columbus, OH.
Maryrose Laguio-VilaDepartment of Internal Medicine, Division of Infectious Disease, Rochester General Hospital, Rochester, NY.
Wissam El AtrouniDivision of Infectious Diseases, Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS.
Marjolein de WitDivision of Pulmonary Disease and Critical Care Medicine, Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA.
Daanish HodaOncology Clinical Program, Intermountain Healthcare, Murray, UT.
Claudia S CohnDepartment of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.
Carla McWilliamsDepartment of Infectious Disease, Cleveland Clinic Florida Weston, Weston, FL.
Carl ShanholtzDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD.
Alan E JonesDepartment of Emergency Medicine, University of Mississippi Medical Center, Jackson, MS.
Jay S RavalDepartment of Pathology, University of New Mexico School of Medicine, Albuquerque, NM.
Simon MuchaDepartment of Critical Care, Respiratory Institute, Cleveland Clinical Health System, Cleveland, OH.
Tina S IpeDepartment of Pathology and Laboratory Medicine, University of Arkansas for Medical Sciences, Little Rock, AR.
Xian QiaoSentara Pulmonary, Critical Care, and Sleep Specialists, Sentara Health, Sentara Norfolk General Hospital, Eastern Virginia Medical School, Norfolk, VA.
Stephen J SchrantzDepartment of Medicine, The University of Chicago, Chicago, IL.
Aarthi ShenoyDepartment of Medicine, MedStar Washington Hospital Center, Washington, DC.
Richard D FremontDepartment of Medicine, Meharry Medical College, Nashville, TN.
Eric J BradyVanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, TN.
Robert H CarnahanDepartment of Pediatrics, Vanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, TN; Department of Radiology, Vanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, TN.
James D ChappellDivision of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.
James E CroweDepartment of Pediatrics, Vanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, TN; Department of Pediatrics, and Department of Pathology, Microbiology, and Immunology, Vanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, TN.
Mark R DenisonDivision of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.
Pavlo GilchukVanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, TN.
Laura J StevensDivision of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.
Rachel E SuttonImmunology and Molecular Pathogeneisis Program, Emory University, Atlanta, GA.
Isaac ThomsenDivision of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.
Sandra M YoderVanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, TN.
Amanda J Bistran-HallVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN.
Jonathan D CaseyDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN.
Christopher J LindsellDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
Li WangDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
Jill M PulleyVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN.
Jillian P RhoadsVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN.
Gordon R BernardVanderbilt Institute for Clinical and Translational Research and Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN.
Todd W RiceVanderbilt Institute for Clinical and Translational Research and Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN.
Passive Immunity Trial for Our Nation (PassITON) Investigators
Vanderbilt University Medical Center · USBeth Israel Deaconess Medical Center · USLouisiana State University · USNewton Wellesley Hospital · USUniversity of Colorado Denver · USUniversity of Washington · USCleveland Clinic · USCleveland Clinic Florida · USEastern Virginia Medical School · USEmory University · USIntermountain Healthcare · USMedStar Washington Hospital Center · USMeharry Medical College · USOur Lady of the Lake Regional Medical Center · USRochester General Hospital · USScripps Research Institute · USThe Ohio State University · USUniversity at Buffalo, State University of New York · USUniversity of Arkansas for Medical Sciences · USUniversity of Chicago · US

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
The RCMI Program in Health Disparities Research at Meharry Medical College - SupplementU54MD007586 · NIMHD · MEHARRY MEDICAL COLLEGE · PI Samuel Evans Adunyah · 2017 to 2026
$48.2M
Bag-Mask Ventilation to PreVent Hypoxemia during Tracheal Intubation in the Emergency Department: A Clinical TrialK23HL153584 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI CASEY, JONATHAN DALE · 2020 to 2024
$900k
NCATS NIH HHS UL1 TR002243NHLBI NIH HHS K23 HL153584NIMHD NIH HHS U54 MD007586
6 · The paper itself

Abstract

backgroundConvalescent plasma has been one of the most common treatments for COVID-19, but most clinical trial data to date have not supported its efficacy. RESEARCH QUESTION: Is rigorously selected COVID-19 convalescent plasma with neutralizing anti-SARS-CoV-2 antibodies an efficacious treatment for adults hospitalized with COVID-19? STUDY DESIGN AND

methodsThis was a multicenter, blinded, placebo-controlled randomized clinical trial among adults hospitalized with SARS-CoV-2 infection and acute respiratory symptoms for < 14 days. Enrolled patients were randomly assigned to receive one unit of COVID-19 convalescent plasma (n = 487) or placebo (n = 473). The primary outcome was clinical status (disease severity) 14 days following study infusion measured with a seven-category ordinal scale ranging from discharged from the hospital with resumption of normal activities (lowest score) to death (highest score). The primary outcome was analyzed with a multivariable ordinal regression model, with an adjusted odds ratio (aOR) < 1.0 indicating more favorable outcomes with convalescent plasma than with placebo. In secondary analyses, trial participants were stratified according to the presence of endogenous anti-SARS-CoV-2 antibodies ("serostatus") at randomization. The trial included 13 secondary efficacy outcomes, including 28-day mortality.

resultsAmong 974 randomized patients, 960 were included in the primary analysis. Clinical status on the ordinal outcome scale at 14 days did not differ between the convalescent plasma and placebo groups in the overall population (aOR, 1.04; one-seventh support interval [1/7 SI], 0.82-1.33), in patients without endogenous antibodies (aOR, 1.15; 1/7 SI, 0.74-1.80), or in patients with endogenous antibodies (aOR, 0.96; 1/7 SI, 0.72-1.30). None of the 13 secondary efficacy outcomes were different between groups. At 28 days, 89 of 482 (18.5%) patients in the convalescent plasma group and 80 of 465 (17.2%) patients in the placebo group had died (aOR, 1.04; 1/7 SI, 0.69-1.58).

interpretationAmong adults hospitalized with COVID-19, including those seronegative for anti-SARS-CoV-2 antibodies, treatment with convalescent plasma did not improve clinical outcomes. CLINICAL

trial registrationClinicalTrials.gov; No.: NCT04362176; URL: www. CLINICALTRIALS: gov.

Indexed as

COVID-19AdultAntibodies, ViralCOVID-19 SerotherapyHospitalizationHumansSARS-CoV-2Treatment OutcomeAntibodies, Viralconvalescent plasmaCOVID-19passive immunitySARS-CoV-2

Identifiers

PMID35780813
PMCPMC9247217
OpenAlexW4283747128

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.