One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients
Sixten Körper, … , Erhard Seifried, Hubert Schrezenmeier
Sixten Körper, … , Erhard Seifried, Hubert Schrezenmeier
Published November 3, 2022
Citation Information: J Clin Invest. 2022;132(24):e163657. https://doi.org/10.1172/JCI163657.
View: Text | PDF
Clinical Research and Public Health

One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients

Abstract

BACKGROUND Results of many randomized trials on COVID-19 convalescent plasma (CCP) have been reported, but information on long-term outcome after CCP treatment is limited. The objectives of this extended observation of the randomized CAPSID trial are to assess long-term outcome and disease burden in patients initially treated with or without CCP.METHODS Of 105 randomized patients, 50 participated in the extended observation. Quality of life (QoL) was assessed by questionnaires and a structured interview. CCP donors (n = 113) with asymptomatic to moderate COVID-19 were included as a reference group.RESULTS The median follow-up of patients was 396 days, and the estimated 1-year survival was 78.7% in the CCP group and 60.2% in the control (P = 0.08). The subgroup treated with a higher cumulative amount of neutralizing antibodies showed a better 1-year survival compared with the control group (91.5% versus 60.2%, P = 0.01). Medical events and QoL assessments showed a consistent trend for better results in the CCP group without reaching statistical significance. There was no difference in the increase in neutralizing antibodies after vaccination between the CCP and control groups.CONCLUSION The trial demonstrated a trend toward better outcome in the CCP group without reaching statistical significance. A predefined subgroup analysis showed a significantly better outcome (long-term survival, time to discharge from ICU, and time to hospital discharge) among those who received a higher amount of neutralizing antibodies compared with the control group. A substantial long-term disease burden remains after severe COVID-19.Trial registration EudraCT 2020-001310-38 and ClinicalTrials.gov NCT04433910.Funding Bundesministerium für Gesundheit (German Federal Ministry of Health).

Authors

Sixten Körper, Beate Grüner, Daniel Zickler, Thomas Wiesmann, Patrick Wuchter, Rainer Blasczyk, Kai Zacharowski, Peter Spieth, Torsten Tonn, Peter Rosenberger, Gregor Paul, Jan Pilch, Joachim Schwäble, Tamam Bakchoul, Thomas Thiele, Julian Knörlein, Matthias M. Dollinger, Jörg Krebs, Martin Bentz, Victor M. Corman, Dzenan Kilalic, Gerlinde Schmidtke-Schrezenmeier, Philipp M. Lepper, Lucas Ernst, Hinnerk Wulf, Alexandra Ulrich, Manfred Weiss, Jan Matthias Kruse, Thomas Burkhardt, Rebecca Müller, Harald Klüter, Michael Schmidt, Bernd Jahrsdörfer, Ramin Lotfi, Markus Rojewski, Thomas Appl, Benjamin Mayer, Philipp Schnecko, Erhard Seifried, Hubert Schrezenmeier

×

Figure 3

Long-term occurrence of secondary outcomes by amount of transfused neutralizing units.

Options: View larger image (or click on image) Download as PowerPoint
Long-term occurrence of secondary outcomes by amount of transfused neutr...
Kaplan-Meier cumulative estimates of probability are shown. In all panels, a “+” indicates a censored patient. (A) The key secondary outcome time to clinical improvement compared in the CCP subgroup that received a low cumulative amount of neutralizing units (red), the CCP subgroup that received a high cumulative amount of neutralizing units (blue), and the control group (green line). P = 0.088 (log-rank test; high amount vs. control group). (B) Time to first negative PCR compared in the CCP subgroup that received a low cumulative amount of neutralizing units (red), the CCP subgroup that received a high cumulative amount of neutralizing units (blue), and the control group (green line). P = 0.019 (log-rank test, high amount vs. control group). (C) Probability of discharge from ICU compared in the CCP subgroup that received a low cumulative amount of neutralizing units (red), the CCP subgroup that received a high cumulative amount of neutralizing units (blue), and the control group (green line). P = 0.025 (log-rank test, high amount group vs. control group). (D) Probability of discharge from hospital compared in the CCP subgroup that received a low cumulative amount of neutralizing units (red), the CCP subgroup that received a high cumulative amount of neutralizing units (blue), and the control group (green line). P = 0.017 (log-rank test, high amount vs. control group).