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

Bibliographic Details
Title: One-year follow-up of the CAPSID randomized trial for high-dose convalescent plasma in severe COVID-19 patients
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
Source: The Journal of Clinical Investigation, Vol 132, Iss 24 (2022)
Publisher Information: American Society for Clinical Investigation, 2022.
Publication Year: 2022
Collection: LCC:Medicine
Subject Terms: COVID-19, Therapeutics, Medicine
More Details: 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).
Document Type: article
File Description: electronic resource
Language: English
ISSN: 1558-8238
Relation: https://doaj.org/toc/1558-8238
DOI: 10.1172/JCI163657
Access URL: https://doaj.org/article/f215c564e7e54be8bf0fb4d93dce1301
Accession Number: edsdoj.f215c564e7e54be8bf0fb4d93dce1301
Database: Directory of Open Access Journals
More Details
ISSN:15588238
DOI:10.1172/JCI163657
Published in:The Journal of Clinical Investigation
Language:English