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
Denkinger, C. M.; Janssen, M.; Schaekel, 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.; Bornhaeuser, M.; Alakel, N.; Witzke, O.; Wolf, T.; Vehreschild, M. J.; Schmiedel, S.; Addo, M. M.; Herth, F.; Kreuter, M.; Tepasse, P.-R.; Hertenstein, B.; Haenel, 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.; Meuer, S.; Kraeusslich, H.-G.; Muel
Show 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.
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