Results of the CAPSID randomized trial for high-dose convalescent plasma in patients with severe COVID-19

Körper, Sixten; Weiss, Manfred; Zickler, Daniel; Wiesmann, Thomas; Zacharowski, Kai; Corman, Victor M; Grüner, Beate; Ernst, Lucas; Spieth, Peter; Lepper, Philipp M; Bentz, Martin; Zinn, Sebastian; Paul, Gregor; Kalbhenn, Johannes; Dollinger, Matthias M; Rosenberger, Peter; Kirschning, Thomas; Thiele, Thomas; Appl, Thomas; Mayer, Benjamin; Schmidt, Michael; Drosten, Christian; Wulf, Hinnerk; Kruse, Jan Matthias; Jungwirth, Bettina; Seifried, Erhard; Schrezenmeier, Hubert

BACKGROUNDCOVID-19 convalescent plasma (CCP) has been considered a treatment option for COVID-19. This trial assessed the efficacy of a neutralizing antibody containing high-dose CCP in hospitalized adults with COVID-19 requiring respiratory support or intensive care treatment.METHODSPatients (n = 105) were randomized 1:1 to either receive standard treatment and 3 units of CCP or standard treatment alone. Control group patients with progress on day 14 could cross over to the CCP group. The primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria for severe COVID-19 on day 21.ResultsThe primary outcome occurred in 43.4% of patients in the CCP group and 32.7% in the control group (P = 0.32). The median time to clinical improvement was 26 days in the CCP group and 66 days in the control group (P = 0.27). The median time to discharge from the hospital was 31 days in the CCP group and 51 days in the control group (P = 0.24). In the subgroup that received a higher cumulative amount of neutralizing antibodies, the primary outcome occurred in 56.0% of the patients (vs. 32.1%), with significantly shorter intervals to clinical improvement (20 vs. 66 days, P < 0.05) and to hospital discharge (21 vs. 51 days, P = 0.03) and better survival (day-60 probability of survival 91.6% vs. 68.1%, P = 0.02) in comparison with the control group.ConclusionCCP added to standard treatment was not associated with a significant improvement in the primary and secondary outcomes. A predefined subgroup analysis showed a significant benefit of CCP among patients who received a larger amount of neutralizing antibodies.Trial registrationClinicalTrials.gov NCT04433910.FundingBundesministerium für Gesundheit (German Federal Ministry of Health): ZMVI1-2520COR802.