Randomisierte Studien zum Einsatz von Rekonvaleszentenplasma bei COVID-19: eine Standortbestimmung

Sixten Körper; Thomas Appl; Bernd Jahrsdörfer; Ramin Lotfi; Markus Rojewski; Patrick Wuchter; Torsten Tonn; Tamam Bakchoul; Mesut Karatas; Michael Schmidt; Harald Klüter; Erhard Seifried; Hubert Schrezenmeier

doi:10.1055/a-1521-7884

Transfusionsmedizin, Table of Contents

Transfusionsmedizin 2021; 11(04): 223-240
DOI: 10.1055/a-1521-7884

Übersicht

Randomisierte Studien zum Einsatz von Rekonvaleszentenplasma bei COVID-19: eine Standortbestimmung

Randomised Trials on the Use of Convalescent Plasma in COVID-19: A Status Review

Sixten Körper

¹Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg-Hessen und Institut für Transfusionsmedizin, Universität Ulm

,

Thomas Appl

¹Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg-Hessen und Institut für Transfusionsmedizin, Universität Ulm

,

Bernd Jahrsdörfer

¹Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg-Hessen und Institut für Transfusionsmedizin, Universität Ulm

,

Ramin Lotfi

¹Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg-Hessen und Institut für Transfusionsmedizin, Universität Ulm

,

Markus Rojewski

¹Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg-Hessen und Institut für Transfusionsmedizin, Universität Ulm

,

Patrick Wuchter

²Institut für Transfusionsmedizin und Immunologie, Medizinische Fakultät Mannheim, Universität Heidelberg; DRK-Blutspendedienst Baden-Württemberg – Hessen, Deutschland

,

Torsten Tonn

³Experimentelle Transfusionsmedizin, Technische Universität Dresden, Deutsches Rotes Kreuz Bluttransfusionsdienst Nord-Ost gGmbH, Dresden, Deutschland

,

Tamam Bakchoul

⁴Institut für klinische und experimentelle Transfusionsmedizin, Universitätsklinikum Tübingen, Tübingen, Deutschland

,

Mesut Karatas

⁵Institut für Transfusionsmedizin und Immunhämatologie, DRK-Bluttransfusionsdienst Baden-Württemberg – Hessen, Frankfurt, Deutschland

,

Michael Schmidt

⁵Institut für Transfusionsmedizin und Immunhämatologie, DRK-Bluttransfusionsdienst Baden-Württemberg – Hessen, Frankfurt, Deutschland

,

Harald Klüter

²Institut für Transfusionsmedizin und Immunologie, Medizinische Fakultät Mannheim, Universität Heidelberg; DRK-Blutspendedienst Baden-Württemberg – Hessen, Deutschland

,

Erhard Seifried

⁵Institut für Transfusionsmedizin und Immunhämatologie, DRK-Bluttransfusionsdienst Baden-Württemberg – Hessen, Frankfurt, Deutschland

,

Hubert Schrezenmeier

¹Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg-Hessen und Institut für Transfusionsmedizin, Universität Ulm

› Author Affiliations

Abstract

Zusammenfassung

Plasma von genesenen Spendern mit COVID-19 (COVID-19 Convalescent Plasma, CCP) wurde als Behandlungsoption für Patienten mit COVID-19 in Betracht gezogen. In der ersten Phase der Pandemie wurden mehrere Fallberichte und Fallkontrollstudien mit Hinweisen auf eine therapeutische Wirkung veröffentlicht. Inzwischen liegen die Ergebnisse zahlreicher randomisierter Studien vor. Die Studien unterscheiden sich in vielen Aspekten, u. a. in den Patientenpopulationen, die von ambulanten Patienten mit mildem COVID-19 bis zu kritisch Kranken reichten, wie auch den Endpunkten. Ebenso war der Behandlungsstandard innerhalb der klinischen Studien sehr unterschiedlich. Vor allem aber unterschied sich das Prüfpräparat CCP erheblich in Bezug auf das Behandlungsschema, das Volumen und den Gehalt an Antikörpern. Im Folgenden werden wir die Ergebnisse der bisher publizierten randomisierten Studien diskutieren. Aus den bisher veröffentlichten Ergebnissen lässt sich eine Wirksamkeit von CCP ableiten, sofern es sehr hohe Titer neutralisierender Antikörper enthält und früh im Krankheitsverlauf verabreicht wird. COVID-19-Rekonvaleszenten-Plasma ist noch keine Routinebehandlung und sollte möglichst weiter in klinischen Studien untersucht werden. Neu konzipierte Studien sollten sich auf die frühe Anwendung von CCP mit einem hohen Gehalt an neutralisierenden Antikörpern bei Patienten mit hohem Risiko für eine Progression zu einer schweren COVID-19-Erkrankung konzentrieren und wichtige Begleitmedikationen kontrollieren.

Abstract

Plasma from recovered donors with COVID-19 (COVID-19 convalescent plasma, CCP) has been considered as a treatment option for patients with COVID-19. Several case reports and case-control studies with evidence of therapeutic effect were published during the initial phase of the pandemic. Results of several randomized trials are now available. The studies differed in terms of patient populations, which ranged from outpatients to critically ill patients, and primary endpoints. Also, the standard of care varied widely within the clinical trials. Most notably, the investigational drug differed significantly in terms of treatment regimen, volume, and antibody content. In the following we will discuss the results of the randomized trials published to date. From the results published to date, we can infer efficacy of CCP that contains high titers of neutralizing antibodies and is administered early in the course of the disease. COVID-19 convalescent plasma is not yet a routine treatment and should not be administered outside of a clinical trial. Newly designed studies should focus on early use of CCP containing high levels of neutralizing antibody and control important concomitant medications.

Schlüsselwörter

Rekonvaleszentenplasma - COVID-19 - randomisierte Studien

Key words

convalescent plasma - COVID-19 - randomized trials

Full Text

References

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