Evidence map›Paper›PMID 33974559›Full record

Trial reportThe Journal of clinical investigation2021

A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19.

Max R O'Donnell, Beatriz Grinsztejn, Matthew J Cummings, Jessica E Justman, Matthew R Lamb, Christina M Eckhardt, Neena M Philip, Ying Kuen Cheung, Vinay Gupta, Esau João and 32 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04359810 (A Phase 2, Multi-Center, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults With COVID-19), which is not on this map. Cited by 110 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 26 pooled it
10.4field-weighted citation impact, top 1% 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.

NCT04359810 phase2completednot on this map

A Phase 2, Multi-Center, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults With COVID-19

TypeinterventionalSponsorMax O'DonnellRan2020 to 2020Enrolled223ConditionsSARS-CoV-2 InfectionArmsConvalescent Plasma (anti-SARS-CoV-2 plasma), Non-convalescent Plasma (control plasma)
3 · Its place in the literature

Who cites it

110 citing papers in PubMed, 26 syntheses or guidelines pooled it, 171 citations in OpenAlex.

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  5. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
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  8. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
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  10. Guideline
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  12. Lessons learned from the use of convalescent plasma for the treatment of COVID-19 and specific considerations for immunocompromised patients.Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis · 2022
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  19. Characteristics of published/registered clinical trials on COVID-19 treatment: A systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2021
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50 more citing papers are in PubMed but not listed here.

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

42 authors at 8 institutions in 3 countries.

Max R O'DonnellDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Beatriz GrinsztejnInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Matthew J CummingsDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Jessica E JustmanDepartment of Epidemiology, and.
Matthew R LambDepartment of Epidemiology, and.
Christina M EckhardtDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Neena M PhilipICAP, Columbia University Mailman School of Public Health, New York, New York, USA.
Ying Kuen CheungDepartment of Biostatistics, Columbia University Mailman School of Public Health, New York, New York, USA.
Vinay GuptaInstitute for Health Metrics and Evaluation, University of Washington, Seattle, Washington, USA.
Esau JoãoHospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Jose Henrique PilottoHospital Geral de Nova Iguaçu, Rio de Janeiro, Brazil and Laboratório de Aids e Imunologia Molecular, Instituto Oswaldo Cruz - Fiocruz, Rio de Janeiro, Brazil.
Maria Pia DinizInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Sandra Wagner CardosoInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Darryl AbramsDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Kartik N RajagopalanDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Sarah E BordenDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Allison WolfDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Leon Claude SidiHospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Alexandre VizzoniInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Valdilea G VelosoInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Zachary C BitanDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Dawn E ScottoDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Benjamin J MeyerVagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA.
Samuel D JacobsonVagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA.
Alex KantorDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Nischay MishraCenter for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.
Lokendra V ChauhanCenter for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.
Elizabeth F StoneDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Flavia Dei ZottiDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Francesca La CarpiaDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Krystalyn E HudsonDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Stephen A FerraraDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Joseph SchwartzDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Brie A StotlerDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Wen-Hsuan W LinDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Sandeep N WontakalDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Beth ShazNew York Blood Center, New York, New York, USA.
Thomas BrieseCenter for Infection and Immunity, Columbia University Mailman School of Public Health, New York, New York, USA.
Eldad A HodDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Steven L SpitalnikDepartment of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, New York, USA.
Andrew EisenbergerDivision of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Walter I LipkinDepartment of Epidemiology, and.
Columbia University Irving Medical Center · USColumbia University · USInstituto Evandro Chagas · BRInstitute of Infection and Immunity · CAHospital Federal dos Servidores do Estado · BRFundação Oswaldo Cruz · BRNew York Blood Center · USUniversity of Washington · US

Funding

The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)U01AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI GRINSZTEJN, BEATRIZ · 2008 to 2011
$14.0M
Elucidating the Spatiotemporal Regulation of a Long Non-Coding RNA Required for NeurodevelopmentK08NS119567 · NINDS · JOHNS HOPKINS UNIVERSITY · PI WONTAKAL, SANDEEP NAGARAJ · 2021 to 2025
$1.1M
NIAID NIH HHS U01 AI069476NIAID NIH HHS UM1 AI069476NINDS NIH HHS K08 NS119567
6 · The paper itself

Abstract

BACKGROUNDAlthough convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited.METHODSWe conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical COVID-19 at 5 sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single transfusion of either convalescent plasma or normal control plasma. The primary outcome was clinical status at 28 days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population.RESULTSOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive normal control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval [CI] 0.83-2.68, P = 0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, P = 0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected.CONCLUSIONIn adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A possible explanation is that survivors remained hospitalized at their baseline clinical status.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.

Indexed as

SARS-CoV-2AdultAgedAged, 80 and overBrazilCOVID-19COVID-19 SerotherapyDouble-Blind MethodFemaleHumansImmunization, PassiveKaplan-Meier EstimateMaleMiddle AgedNew York CityPandemicsCOVID-19Hypoxia

Identifiers

PMID33974559
PMCPMC8245169
OpenAlexW3163808478

What OpenQuestion holds

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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.