Evidence map›Paper›PMID 34504336›Full record

Trial reportNature medicine2021

Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial.

Philippe Bégin, Jeannie Callum, Erin Jamula, Richard Cook, Nancy M Heddle, Alan Tinmouth, Michelle P Zeller, Guillaume Beaudoin-Bussières, Luiz Amorim, Renée Bazin and 24 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04348656 (A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness), which is not on this map. Cited by 156 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
156citing papers in PubMed, 14 pooled it
16.3field-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.

NCT04348656 phase3terminatednot on this map

A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)

TypeinterventionalSponsorHamilton Health Sciences CorporationRan2020 to 2021Enrolled940ConditionsCOVID-19ArmsConvalescent plasma
3 · Its place in the literature

Who cites it

156 citing papers in PubMed, 14 syntheses or guidelines pooled it, 270 citations in OpenAlex.

  1. Pooled it
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  3. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
    Pooled it
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  6. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
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  9. 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
    Pooled it
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  15. Trial
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  17. Efficacy of convalescent plasma in hospitalized COVID-19 patients: findings from a controlled trial.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2024
    Trial
  18. 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
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96 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors at 20 institutions in 3 countries.

Philippe Bégin *Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada. philippe.begin.med@ssss.gouv.qc.ca.ORCID http://orcid.org/0000-0002-9089-4604
Jeannie Callum *Department of Pathology and Molecular Medicine, Kingston Health Sciences Centre and Queen's University, Kingston, Ontario, Canada. jeannie.callum@kingstonhsc.ca.ORCID http://orcid.org/0000-0003-0943-8853
Erin JamulaMcMaster Centre for Transfusion Research, McMaster University, Hamilton, Ontario, Canada.
Richard CookDepartment of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada.
Nancy M HeddleCanadian Blood Services, Ottawa, Ontario, Canada.
Alan TinmouthCanadian Blood Services, Ottawa, Ontario, Canada.
Michelle P ZellerCanadian Blood Services, Ottawa, Ontario, Canada.
Guillaume Beaudoin-BussièresDépartement de Microbiologie, Infectiologie et Immunologie, Université de Montréal, Montreal, Quebec, Canada.
Luiz AmorimHemorio, Hospital and Regional Blood Center, Rio de Janeiro, Brazil.
Renée BazinHéma-Québec, Medical Affairs and Innovation, Quebec City, Quebec, Canada.
Kent Cadogan LoftsgardCONCOR-1 Community Advisory Committee representative, Montreal, Quebec, Canada.
Richard CarlPatient representative, Montreal, Quebec, Canada.
Michaël ChasséDepartment of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.
Melissa M CushingTransfusion Medicine and Cellular Therapy, New York-Presbyterian, New York, NY, USA.
Nick DanemanDepartment of Medicine, Division of Infectious Diseases, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Dana V DevineCanadian Blood Services, Vancouver, British Columbia, Canada.
Jeannot DumaresqDépartement de médecine, CISSS de Chaudière-Appalaches, Lévis, Quebec, Canada.
Dean A FergussonCanadian Blood Services, Ottawa, Ontario, Canada.
Caroline GabeMcMaster Centre for Transfusion Research, McMaster University, Hamilton, Ontario, Canada.
Marshall J GlesbyDivision of Infectious Diseases, Weill Cornell Medical College, New York, NY, USA.ORCID http://orcid.org/0000-0002-2145-148X
Na LiMcMaster Centre for Transfusion Research, McMaster University, Hamilton, Ontario, Canada.
Yang LiuMcMaster Centre for Transfusion Research, McMaster University, Hamilton, Ontario, Canada.
Allison McGeerDepartment of Microbiology, Sinai Health System, Toronto, Ontario, Canada.
Nancy RobitailleHéma-Québec, Montreal, Quebec, Canada.
Bruce S SachaisDepartment of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, USA.
Damon C ScalesDepartment of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Lisa SchwartzDepartment of Health Research Methods, Evidence & Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.ORCID http://orcid.org/0000-0002-4959-225X
Nadine ShehataCanadian Blood Services, Ottawa, Ontario, Canada.
Alexis F TurgeonDepartment of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Quebec City, Quebec, Canada.ORCID http://orcid.org/0000-0001-5675-8791
Heidi WoodZoonotic Diseases and Special Pathogens, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
Ryan ZarychanskiDepartment of Internal Medicine, Sections of Hematology/Medical Oncology and Critical Care, University of Manitoba, Winnipeg, Manitoba, Canada.
Andrés FinziDépartement de Microbiologie, Infectiologie et Immunologie, Université de Montréal, Montreal, Quebec, Canada.
CONCOR-1 Study Group
Donald M Arnold *McMaster Centre for Transfusion Research, McMaster University, Hamilton, Ontario, Canada. arnold@mcmaster.ca.ORCID http://orcid.org/0000-0001-6133-0677
North York General Hospital · CACornell University · USCentre Hospitalier de l’Université de Montréal · CASt. Boniface Hospital · CACentre Hospitalier Universitaire Sainte-Justine · CAHéma-Québec · CAHôpital Maisonneuve-Rosemont · CAMcGill University Health Centre · CAVitalité Health Network · CAUniversity Health Network · CACegep de Saint Jerome · CASunnybrook Health Science Centre · CAThe Scarborough Hospital · CAVancouver General Hospital · CASt. Paul's Hospital · CAUniversité Laval · CAUniversity of Alberta · CACanadian Blood Services · CANiagara Health System · CAQueensway-Carleton Hospital · CA

Funding

UNC-CH CENTER FOR ENVIRONMENTAL HEALTH &SUSCEPTIBILITYP30ES010126 · NIEHS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Stephanie Engel · 2001 to 2026
$36.3M
Fonds de Recherche du Québec - Santé (Fonds de la recherche en sante du Quebec) 281662Gouvernement du Canada | Canadian Institutes of Health Research (Instituts de Recherche en Santé du Canada) 447352NIEHS NIH HHS P30 ES010126
6 · The paper itself

Abstract

The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm-relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94-1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02-1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57-0.95 and OR = 0.66, 95% CI 0.50-0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

Indexed as

AdultAgedAged, 80 and overBrazilCanadaCOVID-19COVID-19 SerotherapyFemaleHospitalizationHumansImmunization, PassiveIntention to Treat AnalysisMaleMiddle AgedSARS-CoV-2Treatment Outcome

Identifiers

PMID34504336
PMCPMC8604729
OpenAlexW3197328793

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.