Evidence map›Paper›PMID 34464358›Full record

Trial reportThe Journal of clinical investigation2021

Results of the CAPSID randomized trial for high-dose convalescent plasma in patients with severe COVID-19.

Sixten Körper, Manfred Weiss, Daniel Zickler, Thomas Wiesmann, Kai Zacharowski, Victor M Corman, Beate Grüner, Lucas Ernst, Peter Spieth, Philipp M Lepper and 18 more

Registry-linked trialOpen access · greenAbstract readMulticenter 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 NCT04433910 (A Randomized, Prospective, Open Label Clinical Trial on the Use of Convalescent Plasma Compared to Best Supportive Care in Patients With Severe COVID-19), which is not on this map. Cited by 55 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 13 pooled it
5.3field-weighted citation impact, top 3% 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.

NCT04433910 phase2completednot on this map

A Randomized, Prospective, Open Label Clinical Trial on the Use of Convalescent Plasma Compared to Best Supportive Care in Patients With Severe COVID-19

TypeinterventionalSponsorDeutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-HessenRan2020 to 2022Enrolled106ConditionsCOVID-19ArmsConvalesscent Plasma
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 13 syntheses or guidelines pooled it, 88 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
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  4. Convalescent plasma for people with COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023
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  7. Guideline
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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
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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

28 authors at 14 institutions in 1 country.

Sixten KörperInstitute for Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen and University Hospital Ulm, and Institute of Transfusion Medicine, and.
Manfred WeissDepartment of Anaesthesiology and Intensive Care Medicine, University Hospital Ulm, Ulm University, Ulm, Germany.
Daniel ZicklerDepartment of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, corporate member of Free University Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Thomas WiesmannDepartment of Anaesthesiology and Intensive Care Medicine, Philipps University Marburg, Marburg, Germany.
Kai ZacharowskiClinic of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
Victor M CormanInstitute of Virology, Charité - Universitätsmedizin Berlin, corporate member of Free University Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health and German Centre for Infection Research, Berlin, Germany.
Beate GrünerDivision of Infectious Diseases, University Hospital and Medical Center Ulm, Ulm, Germany.
Lucas ErnstDepartment of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, corporate member of Free University Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Peter SpiethDepartment of Anesthesiology and Critical Care Medicine, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.
Philipp M LepperDepartment of Internal Medicine V - Pneumology, Allergology, Intensive Care Medicine, Saarland University Hospital, Homburg, Germany.
Martin BentzDepartment of Internal Medicine III, Hospital of Karlsruhe, Karlsruhe, Germany.
Sebastian ZinnClinic of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
Gregor PaulDepartment of Gastroenterology, Hepatology, Pneumology and Infectious Diseases, Klinikum Stuttgart, Stuttgart, Germany.
Johannes KalbhennDepartment of Anesthesiology and Critical Care, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Matthias M DollingerMedical Clinic I, Klinikum Landshut, Landshut, Germany.
Peter RosenbergerDepartment of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Tübingen, Germany.
Thomas KirschningDepartment of Anaesthesiology and Surgical Intensive Care Medicine, University of Heidelberg, University Medical Centre Mannheim, Mannheim, Germany.
Thomas ThieleInstitute of Immunology and Transfusion Medicine, University Hospital Greifswald, Greifswald, Germany.
Thomas ApplInstitute for Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen and University Hospital Ulm, and Institute of Transfusion Medicine, and.
Benjamin MayerInstitute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.
Michael SchmidtInstitute of Transfusion Medicine and Immunohematology, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen, Frankfurt, Germany.
Christian DrostenInstitute of Virology, Charité - Universitätsmedizin Berlin, corporate member of Free University Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health and German Centre for Infection Research, Berlin, Germany.
Hinnerk WulfDepartment of Anaesthesiology and Intensive Care Medicine, Philipps University Marburg, Marburg, Germany.
Jan Matthias KruseDepartment of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, corporate member of Free University Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Bettina JungwirthDepartment of Anaesthesiology and Intensive Care Medicine, University Hospital Ulm, Ulm University, Ulm, Germany.
Erhard SeifriedInstitute of Transfusion Medicine and Immunohematology, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen, Frankfurt, Germany.
Hubert SchrezenmeierInstitute for Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen and University Hospital Ulm, and Institute of Transfusion Medicine, and.
CAPSID Clinical Trial Group
German Red Cross · DEHumboldt-Universität zu Berlin · DEUniversity Hospital Ulm · DEGoethe University Frankfurt · DEPhilipps University of Marburg · DEHeidelberg University · DEKlinikum Stuttgart · DEUniversitätsklinikum des Saarlandes · DEUniversitätsmedizin Greifswald · DEUniversität Ulm · DEUniversity Children's Hospital Tübingen · DEUniversity Hospital Carl Gustav Carus · DEUniversity of Applied Sciences Landshut · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUNDCOVID-19 convalescent plasma (CCP) has been considered a treatment option for COVID-19. This trial assessed the efficacy of a neutralizing antibody containing high-dose CCP in hospitalized adults with COVID-19 requiring respiratory support or intensive care treatment.METHODSPatients (n = 105) were randomized 1:1 to either receive standard treatment and 3 units of CCP or standard treatment alone. Control group patients with progress on day 14 could cross over to the CCP group. The primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria for severe COVID-19 on day 21.ResultsThe primary outcome occurred in 43.4% of patients in the CCP group and 32.7% in the control group (P = 0.32). The median time to clinical improvement was 26 days in the CCP group and 66 days in the control group (P = 0.27). The median time to discharge from the hospital was 31 days in the CCP group and 51 days in the control group (P = 0.24). In the subgroup that received a higher cumulative amount of neutralizing antibodies, the primary outcome occurred in 56.0% of the patients (vs. 32.1%), with significantly shorter intervals to clinical improvement (20 vs. 66 days, P < 0.05) and to hospital discharge (21 vs. 51 days, P = 0.03) and better survival (day-60 probability of survival 91.6% vs. 68.1%, P = 0.02) in comparison with the control group.ConclusionCCP added to standard treatment was not associated with a significant improvement in the primary and secondary outcomes. A predefined subgroup analysis showed a significant benefit of CCP among patients who received a larger amount of neutralizing antibodies.Trial registrationClinicalTrials.gov NCT04433910.FundingBundesministerium für Gesundheit (German Federal Ministry of Health): ZMVI1-2520COR802.

Indexed as

SARS-CoV-2AgedAntibodies, NeutralizingAntibodies, ViralCombined Modality TherapyCOVID-19COVID-19 SerotherapyCross-Over StudiesFemaleHumansImmunization, PassiveKaplan-Meier EstimateMaleMiddle AgedPandemicsProspective StudiesAntibodies, NeutralizingAntibodies, ViralClinical TrialsCOVID-19Immunoglobulins

Identifiers

PMID34464358
PMCPMC8516466
OpenAlexW3196996705

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.