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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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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, Claudia M; Janssen, Maike; Schäkel, Ulrike; Gall, Julia; Leo, Albrecht; Stelmach, Patrick; Weber, Stefan F; Krisam, Johannes; Baumann, Lukas; Stermann, Jacek; Merle, Uta; Weigand, Markus A; Nusshag, Christian; Bullinger, Lars; Schrezenmeier, Jens-Florian; Bornhäuser, Martin; Alakel, Nael; Witzke, Oliver; Wolf, Timo; Vehreschild, Maria J G T; Schmiedel, Stefan; Addo, Marylyn M; Herth, Felix; Kreuter, Michael; Tepasse, Phil-Robin; Hertenstein, Bernd; Hänel, Mathias; Morgner, Anke; Kiehl, Michael; Hopfer, Olaf; Wattad, Mohammad-Amen; Schimanski, Carl C; Celik, Cihan; Pohle, Thorsten; Ruhe, Matthias; Kern, Winfried V; Schmitt, Anita; Lorenz, Hanns-Martin; Souto-Carneiro, Margarida; Gaeddert, Mary; Halama, Niels; Meuer, Stefan; Kräusslich, Hans-Georg; Müller, Barbara; Schnitzler, Paul; Parthé, Sylvia; Bartenschlager, Ralf; Gronkowski, Martina; Klemmer, Jennifer; Schmitt, Michael; Dreger, Peter; Kriegsmann, Katharina; Schlenk, Richard F; Müller-Tidow, Carsten.

In: NAT CANCER, Vol. 4, No. 1, 01.2023, p. 96-107.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Denkinger, CM, Janssen, M, Schäkel, U, Gall, J, Leo, A, Stelmach, P, Weber, SF, Krisam, J, Baumann, L, Stermann, J, Merle, U, Weigand, MA, Nusshag, C, Bullinger, L, Schrezenmeier, J-F, Bornhäuser, M, Alakel, N, Witzke, O, Wolf, T, Vehreschild, MJGT, Schmiedel, S, Addo, MM, Herth, F, Kreuter, M, Tepasse, P-R, Hertenstein, B, Hänel, M, Morgner, A, Kiehl, M, Hopfer, O, Wattad, M-A, Schimanski, CC, Celik, C, Pohle, T, Ruhe, M, Kern, WV, Schmitt, A, Lorenz, H-M, Souto-Carneiro, M, Gaeddert, M, Halama, N, Meuer, S, Kräusslich, H-G, Müller, B, Schnitzler, P, Parthé, S, Bartenschlager, R, Gronkowski, M, Klemmer, J, Schmitt, M, Dreger, P, Kriegsmann, K, Schlenk, RF & Müller-Tidow, C 2023, 'Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial', NAT CANCER, vol. 4, no. 1, pp. 96-107. https://doi.org/10.1038/s43018-022-00503-w

APA

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., ... Müller-Tidow, C. (2023). Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial. NAT CANCER, 4(1), 96-107. https://doi.org/10.1038/s43018-022-00503-w

Vancouver

Denkinger CM, Janssen M, Schäkel U, Gall J, Leo A, Stelmach P et al. Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial. NAT CANCER. 2023 Jan;4(1):96-107. https://doi.org/10.1038/s43018-022-00503-w

Bibtex

@article{043cce20ae9a472fa50e9d5d1112220d,
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",
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.",
author = "Denkinger, {Claudia M} and Maike Janssen and Ulrike Sch{\"a}kel and Julia Gall and Albrecht Leo and Patrick Stelmach and Weber, {Stefan F} and Johannes Krisam and Lukas Baumann and Jacek Stermann and Uta Merle and Weigand, {Markus A} and Christian Nusshag and Lars Bullinger and Jens-Florian Schrezenmeier and Martin Bornh{\"a}user and Nael Alakel and Oliver Witzke and Timo Wolf and Vehreschild, {Maria J G T} and Stefan Schmiedel and Addo, {Marylyn M} and Felix Herth and Michael Kreuter and Phil-Robin Tepasse and Bernd Hertenstein and Mathias H{\"a}nel and Anke Morgner and Michael Kiehl and Olaf Hopfer and Mohammad-Amen Wattad and Schimanski, {Carl C} and Cihan Celik and Thorsten Pohle and Matthias Ruhe and Kern, {Winfried V} and Anita Schmitt and Hanns-Martin Lorenz and Margarida Souto-Carneiro and Mary Gaeddert and Niels Halama and Stefan Meuer and Hans-Georg Kr{\"a}usslich and Barbara M{\"u}ller and Paul Schnitzler and Sylvia Parth{\'e} and Ralf Bartenschlager and Martina Gronkowski and Jennifer Klemmer and Michael Schmitt and Peter Dreger and Katharina Kriegsmann and Schlenk, {Richard F} and Carsten M{\"u}ller-Tidow",
note = "{\textcopyright} 2022. The Author(s).",
year = "2023",
month = jan,
doi = "10.1038/s43018-022-00503-w",
language = "English",
volume = "4",
pages = "96--107",
journal = "NAT CANCER",
issn = "2662-1347",
publisher = "NATURE PUBLISHING GROUP",
number = "1",

}

RIS

TY - JOUR

T1 - Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial

AU - Denkinger, Claudia M

AU - Janssen, Maike

AU - Schäkel, Ulrike

AU - Gall, Julia

AU - Leo, Albrecht

AU - Stelmach, Patrick

AU - Weber, Stefan F

AU - Krisam, Johannes

AU - Baumann, Lukas

AU - Stermann, Jacek

AU - Merle, Uta

AU - Weigand, Markus A

AU - Nusshag, Christian

AU - Bullinger, Lars

AU - Schrezenmeier, Jens-Florian

AU - Bornhäuser, Martin

AU - Alakel, Nael

AU - Witzke, Oliver

AU - Wolf, Timo

AU - Vehreschild, Maria J G T

AU - Schmiedel, Stefan

AU - Addo, Marylyn M

AU - Herth, Felix

AU - Kreuter, Michael

AU - Tepasse, Phil-Robin

AU - Hertenstein, Bernd

AU - Hänel, Mathias

AU - Morgner, Anke

AU - Kiehl, Michael

AU - Hopfer, Olaf

AU - Wattad, Mohammad-Amen

AU - Schimanski, Carl C

AU - Celik, Cihan

AU - Pohle, Thorsten

AU - Ruhe, Matthias

AU - Kern, Winfried V

AU - Schmitt, Anita

AU - Lorenz, Hanns-Martin

AU - Souto-Carneiro, Margarida

AU - Gaeddert, Mary

AU - Halama, Niels

AU - Meuer, Stefan

AU - Kräusslich, Hans-Georg

AU - Müller, Barbara

AU - Schnitzler, Paul

AU - Parthé, Sylvia

AU - Bartenschlager, Ralf

AU - Gronkowski, Martina

AU - Klemmer, Jennifer

AU - Schmitt, Michael

AU - Dreger, Peter

AU - Kriegsmann, Katharina

AU - Schlenk, Richard F

AU - Müller-Tidow, Carsten

N1 - © 2022. The Author(s).

PY - 2023/1

Y1 - 2023/1

N2 - 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.

AB - 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.

U2 - 10.1038/s43018-022-00503-w

DO - 10.1038/s43018-022-00503-w

M3 - SCORING: Journal article

C2 - 36581734

VL - 4

SP - 96

EP - 107

JO - NAT CANCER

JF - NAT CANCER

SN - 2662-1347

IS - 1

ER -