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

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Item Type:Article
Title:Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial
Creators Name:Denkinger, C.M. and Janssen, M. and Schäkel, U. and Gall, J. and Leo, A. and Stelmach, P. and Weber, S.F. and Krisam, J. and Baumann, L. and Stermann, J. and Merle, U. and Weigand, M.A. and Nusshag, C. and Bullinger, L. and Schrezenmeier, J.F. and Bornhäuser, M. and Alakel, N. and Witzke, O. and Wolf, T. and Vehreschild, M.J.G.T. and Schmiedel, S. and Addo, M.M. and Herth, F. and Kreuter, M. and Tepasse, P.R. and Hertenstein, B. and Hänel, M. and Morgner, A. and Kiehl, M. and Hopfer, O. and Wattad, M.A. and Schimanski, C.C. and Celik, C. and Pohle, T. and Ruhe, M. and Kern, W.V. and Schmitt, A. and Lorenz, H.M. and Souto-Carneiro, M. and Gaeddert, M. and Halama, N. and Meuer, S. and Kräusslich, H.G. and Müller, B. and Schnitzler, P. and Parthé, S. and Bartenschlager, R. and Gronkowski, M. and Klemmer, J. and Schmitt, M. and Dreger, P. and Kriegsmann, K. and Schlenk, Ri.F. and Müller-Tidow, C.
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.
Keywords:Cancer, Clinical Trials, SARS-CoV-2, Viral Infection
Source:Nature Cancer
Publisher:Springer Nature
Page Range:96-107
Date:January 2023
Official Publication:https://doi.org/10.1038/s43018-022-00503-w
PubMed:View item in PubMed
Related to:
https://edoc.mdc-berlin.de/22638/Preprint version

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