Evidence map›Paper›PMID 41592860›Full record

ReviewExpert review of anti-infective therapy2026

COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval.

David J Sullivan, Rita Reik, Alicia Prichard, Marlene Pagan, Aaron A R Tobian, Patrizio Caturegli, Andrew Pekosz, Sabra L Klein, Evan M Bloch, Shmuel Shoham and 11 more

Abstract readReview
In one paragraph

Review in Expert review of anti-infective therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

21 authors.

David J SullivanW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Rita ReikExecutive Leadership, OneBlood, Inc ., St. Petersburg, FL, USA.
Alicia PrichardExecutive Leadership, OneBlood, Inc ., St. Petersburg, FL, USA.
Marlene PaganExecutive Leadership, OneBlood, Inc ., St. Petersburg, FL, USA.
Aaron A R TobianDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Patrizio CaturegliDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Andrew PekoszW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Sabra L KleinW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Evan M BlochDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0001-8181-9517
Shmuel ShohamDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Kelly A GeboDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Michael J JoynerDepartment of Anesthesiology & Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.
Jonathon W SenefeldDepartment of Health and Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois Urbana-Champaign, Urbana, IL, USA.
Massimo FranchiniDepartment of Transfusion Medicine and Hematology, Carlo Poma Hospital, Mantova, Italy.
Daniele FocosiNorth-Western Tuscany Blood Bank, Pisa University Hospital, Pisa, Italy.
Suchitra PandeyDepartment of Pathology and Stanford Blood Center, Stanford University, Palo Alto, CA, USA.
Karen LaneDepartment of Neurology, Brain Injury Outcomes, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Nichol A McBeeDepartment of Neurology, Brain Injury Outcomes, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Liise-Anne PirofskiMedicine, Division of Infectious Diseases, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.
Arturo CasadevallW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Daniel F HanleyDepartment of Neurology, Brain Injury Outcomes, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Funding

Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
Conjugate vaccines for prevention and treatment of cryptococcosis - COVID-19 Revision SupplementR01AI152078 · NIAID · JOHNS HOPKINS UNIVERSITY · PI CASADEVALL, ARTURO · 2020 to 2024
$5.1M
NCATS NIH HHS U24 TR001609NIAID NIH HHS R01 AI152078
6 · The paper itself

Abstract

introductionCOVID-19 convalescent plasma with high anti-SARS-CoV-2 antibody levels transfused within 6 months from donor collection was formally approved by the Food and Drug Administration in December 2024 for COVID-19 treatment in immunocompromised patients. Here we summarize the safety and efficacy data submitted for the Biologics License Application. AREAS COVERED: Safety evaluation in over 100,000 individuals in the expanded access program and 24,000 in randomized controlled trials, showed no serious adverse event increases. Robust randomized controlled trials established efficacy in four distinct disease stages: outpatient, inpatient, newly mechanically ventilated, and in those immunocompromised to prevent acute disease progression or eliminate persistent viral carriage. Pharmacokinetics revealed a three-liter distribution volume with viral specific antibody effective dose near 2-50 mg. Major SARS-CoV-2 antibody-mediated antiviral actions included direct neutralization by viral-binding interference to cell receptors and fragment-crystallizable mediated antiviral effects that reduce virions. Virus neutralization correlated with high anti-Spike antibody levels and antibody levels in the top donor plasma deciles retains therapeutic neutralization against future variants. EXPERT OPINION: With pandemic progression, the COVID-19 convalescent plasma safety and efficacy evidence quality increased. Ultimate regulatory approval required robust randomized control efficacy data. Future infectious disease outbreaks require randomized controlled trials in the convalescent plasma roadmap.

Indexed as

Antibodies, ViralCOVID-19SARS-CoV-2Antibodies, NeutralizingCOVID-19 SerotherapyDrug ApprovalHumansImmunization, PassiveImmunocompromised HostRandomized Controlled Trials as TopicUnited StatesUnited States Food and Drug AdministrationAntibodies, NeutralizingAntibodies, ViralConvalescent plasmaCOVID-19neutralization antibody levelspharmacokineticsrandomized controlled trialsafetySARS-CoV-2

Identifiers

PMID41592860
PMCPMC12949555

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.