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

Item Type:

Preprint

Title:

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, R.F. and Müller-Tidow, C.

Abstract:

Cancer patients are at high risk of severe COVID-19 with high morbidity and mortality. Further, impaired humoral response renders 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 multicenter trial (https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632- 10/DE) in hospitalized patients with severe COVID-19 within four risk groups (1, cancer; 2, immunosuppression; 3, lab-based risk factors; 4, advanced age) randomized to standard of care (CONTROL) or standard of care plus convalescent/vaccinated anti-SARS-CoV-2 plasma (PLASMA). For the four groups combined, PLASMA did not improve clinically compared to CONTROL (HR 1.29; p=0.205). However, cancer patients experienced shortened median time to improvement (HR 2.50, p=0.003) and superior survival in PLASMA vs. CONTROL (HR 0.28; p=0.042). Neutralizing antibody activity increased in PLASMA but not in CONTROL cancer patients (p=0.001). Taken together, convalescent/vaccinated plasma may improve COVID-19 outcome in cancer patients unable to intrinsically generate an adequate immune response.

Keywords:

SARS-CoV-2, Plasma therapy, Cancer, Immunodeficiency, Randomized-controlled trial

Source:

medRxiv

Publisher:

Cold Spring Harbor Laboratory Press

Article Number:

2022.10.10.22280850

Date:

13 October 2022

Official Publication:

https://doi.org/10.1101/2022.10.10.22280850

Related to:

URL	URL Type
http://edoc.mdc-berlin.de/23008/	Final version

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