On Friday, January 29, 2021, after a review of the interim results that included 614 patients, the independent data safety monitoring committee for the CONCOR-1 trial recommended that the trial should stop enrollment as it has met the pre-defined threshold for futility, which means that the study is unlikely to demonstrate a benefit of convalescent plasma even if more patients are enrolled. There were no safety concerns.
The study team is in the process of completing the follow-up data for all enrolled patients, and final study results will be released once the complete dataset is available.
CONCOR-1 (NCT 04348656) is a randomized, open-label trial of convalescent plasma or standard of care for hospitalized adults with acute COVID-19 respiratory illness (www.concor1.ca). The primary endpoint is intubation or death at 30 days. In total, 940 patients were randomized at 73 hospitals in Canada, the U.S. and Brazil.
This international collaboration included academic and community hospitals, a community advisory committee and four blood suppliers – Canadian Blood Services, Héma-Québec, the New York Blood Center and Hemorio.
The trial was funded by the Canadian Institutes of Health Research, Canadian Blood Services, Héma-Québec, Ontario Research Fund, Québec ministère de l’Économie et de l’Innovation, the University of Toronto, the Government of Saskatchewan Ministry of Health, Hamilton Academic Health Sciences Organization, Sunnybrook Academic Health Sciences Centre, University Health Network, McMaster University, University Health Foundation at University of Alberta Hospital, Sunnybrook Hospital Foundation, CHU Sainte-Justine Foundation, and numerous generous private donors.
The dedication of hundreds of people made this trial possible. We would like to sincerely thank the patients and their family members, plasma donors, research teams, blood bank staff, study investigators, blood suppliers, and funders.
Co-principal investigators
Donald Arnold, Professor of Medicine, McMaster University
Jeannie Callum, Associate Scientist, Sunnybrook Research Institute and Professor, Pathology and Molecular Medicine, Queen’s University and University of Toronto
Philippe Bégin, Clinician Scientist, CHU Sainte-Justine and CHUM and Associate Professor, Université de Montréal