Early, very high-titre convalescent plasma therapy in clinically vulnerable individuals with mild COVID-19: an international, randomised, open-label trial

作者：Simone Hoffmann, Eva Schrezenmeier, Maxime Desmarets, Fabian Halleck, Antoine Dürrbach, Lynn Peters, Anna Tremmel, Alina Seidel, Marita Führer, Friederike Bachmann, Jens Schrezenmeier, Jochen Greiner, Sixten Körper, Henrike Hofmann, Carolin Ludwig, Christiane Vieweg, Bernd Jahrsdörfer, Klemens Budde, Michael Schmidt, Jan Münch, Nizar Joher, Étienne Daguindau, Beate Grüner, Gaëlle Brunotte, Charline Vauchy, Erhard Seifried, Daniel Bradshaw, Lise J Estcourt, David Roberts, Éric Toussirot, Bart Rijnders, Pierre Tiberghien, Hubert Schrezenmeier · 发表于：EBioMedicine · 年份：2025 · DOI：10.1016/j.ebiom.2025.105613 · 被引用次数：21 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、Immune responses and vaccinations

BACKGROUND: COVID-19 convalescent plasma (CCP) is a treatment option for COVID-19. This study investigated the safety and efficacy of early, very high-titre CCP in immunocompromised individuals with mild COVID-19. METHODS: This randomised, controlled, open-label trial assessed CCP in immunocompromised patients (n = 120) with mild COVID-19 in 10 clinical trial centres across Germany, France, and the Netherlands. Patients were randomised 1:1 to receive either standard of care (SoC) alone (SoC group) or SoC and 2 units of CCP. Most patients (89.7%) had received ≥3 SARS-CoV-2 vaccinations. The primary endpoint was hospitalisation for progressive COVID-19 symptoms or death by day 28 after randomisation, analysed on a modified intention-to-treat basis (117 patients). The safety analysis included the full analysis set. The trial is registered with EudraCT 2021-006621-22, and ClinicalTrials.gov, NCT05271929. FINDINGS: Between April 11, 2022 and November 27, 2023, 120 patients were enrolled. Patients in the CCP group received a median of 559 ml CCP from convalescent, vaccinated donors with very high levels of SARS-CoV-2 antibodies (median 81,810 IU/ml) at a median 4 days after symptom onset. The primary outcome occurred in 5/58 patients (8.6%) in the SoC group and in 0/59 patients (0%) in the CCP group, difference -8.6% (95% confidence interval of difference -19% to -0.80%; p-value 0.027; Fisher's exact test). The course of SARS-CoV-2 antibodies in the patients demonstrated a passive ...