Rekonvaleszentenplasma zur Behandlung von schwerem COVID-19: Rationale und Design einer randomisierten, offenen klinischen Studie von Rekonvaleszentenplasma verglichen mit bestmöglicher supportiver Behandlung (CAPSID-Studie)

Sixten Körper; Bernd Jahrsdörfer; Thomas Appl; Harald Klüter; Erhard Seifried; Hubert Schrezenmeier

doi:10.1055/a-1090-0408

Transfusionsmedizin 2020; 10(03): 143-149
DOI: 10.1055/a-1090-0408

Praxistipp

Rekonvaleszentenplasma zur Behandlung von schwerem COVID-19: Rationale und Design einer randomisierten, offenen klinischen Studie von Rekonvaleszentenplasma verglichen mit bestmöglicher supportiver Behandlung (CAPSID-Studie)

Convalescent Plasma for Treatment of Severe COVID-19: Rationale and Designing of a Randomized, Open-Label Clinical Trial of Convalescent Plasma Compared to Best Supportive Care (CAPSID Trial)

Sixten Körper

¹Institut für Klinische Transfusionsmedizin und Immungenetik, Ulm

,

Bernd Jahrsdörfer

¹Institut für Klinische Transfusionsmedizin und Immungenetik, Ulm

,

Thomas Appl

¹Institut für Klinische Transfusionsmedizin und Immungenetik, Ulm

,

Harald Klüter

²Institut für Transfusionsmedizin und Immunologie, Mannheim

,

Erhard Seifried

³Institut für Transfusionsmedizin und Immunhämatologie, Frankfurt am Main

,

Hubert Schrezenmeier

¹Institut für Klinische Transfusionsmedizin und Immungenetik, Ulm

› Institutsangaben

Abstract

Zusammenfassung

Rekonvaleszentenplasma wurde bei Patienten mit akuten, viralen respiratorischen Erkrankungen mit schwerem Verlauf eingesetzt (SARS- oder MERS-Coronavirus, Influenza H1N1, H5N1). Diese Studien erbrachten Hinweise auf eine Reduktion der Viruslast, einer Verkürzung des Krankenhausaufenthalts und eine Reduktion der Mortalität durch Rekonvaleszentenplasma. Die Wirkung konnte jedoch nicht abschließend belegt werden, da es sich nicht um randomisierte Studien handelte. Nach einer SARS-CoV-2-Infektion kommt es bei den meisten Patienten zu einer raschen Bildung von neutralisierenden Antikörpern. Wegen der pandemischen Entwicklung gibt es eine wachsende Zahl Genesener mit neutralisierenden Antikörpern, die als potenzielle Spender in Betracht kommen. Wir konzipierten eine prospektive, randomisierte Studie, um die Wirksamkeit und Sicherheit von Rekonvaleszentenplasma zur Therapie von schwerem COVID-19 und dessen Wirkmechanismus zu untersuchen (CAPSID-Studie). In diesem Beitrag werden die Rationale und das Design der Studie vorgestellt.

Abstract

Convalescent plasma therapy was administered in patients with acute, viral respiratory disorders with severe clinical course (SARS- or MERS coronavirus, influenza H1N1, H5N1). These studies suggested that convalescent plasma is likely to improve viral clearance, reduce the length of hospital stay and reduce mortality and appeared to be safe. However, since controlled randomized trials were lacking only low-quality evidence was available. Most patients mount a strong humoral immune response early in the course of a SARS-CoV-2 infection, including neutralizing antibodies. Due to the pandemic an increasing number of convalescent patients who are potential donors for SARS-CoV-2 convalescent plasma will be available. We designed a prospective randomized clinical trial to study the safety and efficacy of convalescent plasma for treatment of severe COVID-19 and its mechanism of action (CAPSID trial). Here we present the rationale for this trial and major aspects of the study outline.

Schlüsselwörter

SARS-CoV-2-Infektion - COVID-19 - Rekonvaleszentenplasma - randomisierte klinische Prüfung

Key words

SARS-CoV-2 infection - COVID-19 - convalescent plasma - randomized clinical trial

Volltext

Referenzen

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