Journal Article

DKFZ-2022-03217

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial.

Denkinger, C. M. ; Janssen, M. ; Schäkel, U. ; Gall, J. ; Leo, A. ; Stelmach, P. ; Weber, S. F. ; Krisam, J. ; Baumann, L. ; Stermann, J. ; Merle, U. ; Weigand, M. A. ; Nusshag, C. ; Bullinger, L. ; Schrezenmeier, J.-F. ; Bornhäuser, M. ; Alakel, N. ; Witzke, O. ; Wolf, T. ; Vehreschild, M. J. G. T. ; Schmiedel, S. ; Addo, M. M. ; Herth, F. ; Kreuter, M. ; Tepasse, P.-R. ; Hertenstein, B. ; Hänel, M. ; Morgner, A. ; Kiehl, M. ; Hopfer, O. ; Wattad, M.-A. ; Schimanski, C. C. ; Celik, C. ; Pohle, T. ; Ruhe, M. ; Kern, W. V. ; Schmitt, A. ; Lorenz, H.-M. ; Souto-Carneiro, M. ; Gaeddert, M. ; Halama, N.DKFZ* ; Meuer, S. ; Kräusslich, H.-G. ; Müller, B. ; Schnitzler, P. ; Parthé, S. ; Bartenschlager, R. ; Gronkowski, M. ; Klemmer, J. ; Schmitt, M. ; Dreger, P. ; Kriegsmann, K. ; Schlenk, R. F. ; Müller-Tidow, C.

2023
Nature Research London

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Please use a persistent id in citations: doi:10.1038/s43018-022-00503-w

Abstract: 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 the control cohort of patients with cancer (P = 0.001). Taken together, convalescent/vaccinated plasma may improve COVID-19 outcomes in patients with cancer who are unable to intrinsically generate an adequate immune response.

Note: 2023 Jan;4(1):96-107 / HI-TRON

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Contributing Institute(s):

1. Translationale Immuntherapie (D240)

Research Program(s):

1. 314 - Immunologie und Krebs (POF4-314) (POF4-314)

Appears in the scientific report 2022

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; DEAL Nature ; Essential Science Indicators ; IF >= 20 ; JCR ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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