Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial

作者：Claudia Maria Denkinger, Maike Janssen, Ulrike Schäkel, Julia Gall, Albrecht Leo, Patrick Stelmach, Stefan Fabian Weber, Johannes Krisam, Lukas Baumann, Jacek Stermann, Uta Merle, Markus A. Weigand, Christian Nußhag, Lars Bullinger, Jens Schrezenmeier, Martin Bornhäuser, Nael Alakel, Oliver Witzke, Timo Wolf, Maria J. G. T. Vehreschild, Stefan Schmiedel, Marylyn M. Addo, Felix J.F. Herth, Michael Kreuter, Phil‐Robin Tepasse, Bernd Hertenstein, Mathias Hänel, Anke Morgner, Michael G Kiehl, Olaf Hopfer, Mohammad-Amen Wattad, Carl Christoph Schimanski, Cihan Celik, Thorsten Pohle, Matthias Ruhe, Winfried V. Kern, Anita Schmitt, Hanns‐Martin Lorenz, Margarida Souto‐Carneiro, Mary Gaeddert, Niels Halama, Stefan C Meuer, Hans‐Georg Kräusslich, Barbara Theresia Müller, Paul Schnitzler, Sylvia Parthé, Ralf F. W. Bartenschlager, Martina Gronkowski, Jennifer Klemmer, Michael W. Schmitt, Peter Dreger, Katharina Kriegsmann, Richard F. Schlenk, Carsten Müller‐Tidow · 发表于：Nature Cancer · 年份：2022 · DOI：10.1038/s43018-022-00503-w · 被引用次数：62 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、COVID-19 and healthcare impacts

Patients with cancer are at high risk of severe coronavirus disease 2019 (COVID-19), with high morbidity and mortality. Furthermore, impaired humoral response renders severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines less effective and treatment options are scarce. Randomized trials using convalescent plasma are missing for high-risk patients. Here, we performed a randomized, open-label, multicenter trial ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE ) in hospitalized patients with severe COVID-19 (n = 134) within four risk groups ((1) cancer (n = 56); (2) immunosuppression (n = 16); (3) laboratory-based risk factors (n = 36); and (4) advanced age (n = 26)) randomized to standard of care (control arm) or standard of care plus convalescent/vaccinated anti-SARS-CoV-2 plasma (plasma arm). No serious adverse events were observed related to the plasma treatment. Clinical improvement as the primary outcome was assessed using a seven-point ordinal scale. Secondary outcomes were time to discharge and overall survival. For the four groups combined, those receiving plasma did not improve clinically compared with those in the control arm (hazard ratio (HR) = 1.29; P = 0.205). However, patients with cancer experienced a shortened median time to improvement (HR = 2.50; P = 0.003) and superior survival with plasma treatment versus the control arm (HR = 0.28; P = 0.042). Neutralizing antibody activity increased in the plasma cohort but not in...