Periodic Reporting for period 4 - SUPPORT-E (SUPporting high quality evaluation of COVID-19 convalescent Plasma thrOughoutT Europe)
Reporting period: 2023-07-01 to 2024-12-31
Due to the lack of effective treatments for COVID-19, the need for new treatment strategies such as convalescent plasma has emerged during the pandemic. Initial controversial findings from research and the use of convalescent plasma from patients with COVID-19 (CCP) have highlighted the need to develop recommendations based on scientific and clinical knowledge derived from newly developed standardized tests and evaluation of data on CCP donors and recipients. In this context, the SUPPORT-E project was established, which aims to support high-quality clinical and scientific evaluation of CCPs. The main goals of the project, which uses, among other things, a special database created by the European Commission, are to help EU countries both in evaluating the effectiveness of a new therapeutic solution for dealing with the coronavirus pandemic, as well as in developing new strategies for dealing with possible future pandemics. SUPPORT-E will advance the current state-of-the-art by delivering 1) an assessment of the efficacy of CCP as a potential treatment of COVID-19, 2) the much-needed harmonised evidence-based recommendations derived from data on the use of CCP in clinical trials and monitored access programmes for COVID-19 patients in Europe. Further, standardised informative in vitro assays providing scientific insights that could support such recommendations will also be developed. SUPPORT-E hereby promotes and conducts data collection and analysis to identify factors that predict the therapeutic efficacy of CCP. The project also attempts to remove access barriers to anti-SARS-CoV-2 testing to support faster and more accessible donor screening and help direct the blood establishments (BEs) to begin prioritising plasma collections from COVID-19 convalescent donors and expedite the availability of these products. If CCP proves to be a valid therapeutic, the SUPPORT-E recommendations will ultimately serve as a critical tool to facilitate the implementation of a CCP approach across all EU Member States to combat COVID-19 infection.
SUPPORT-E was carried out by a consortium of 12 partners representing several European blood establishments and national competent authorities and coordinated by the European Blood Alliance (EBA). The project was divided into seven Work Packages (WP). It started on 01 July 2020, was extended twice, and ended on 31 December 2024.
Consortium members achieved the project objectives by working together within and between WPs.
· WP 1 reviewed and assessed available literature, developed preliminary assessment criteria and guidelines for a high-quality evaluation of clinical trials or monitored access programs for CCP use and continuously followed ongoing clinical trials. Based on these guidelines, WP1 identified several clinical trials eligible for support by the project.
· WP 2 contacted selected trials to verify their availability to collaborate with SUPPORT-E, performed a gap analysis of information in these trials and regularly updated knowledge as new data emerged. To fill the identified gaps, the project consortium decided to financially support the European multicentre COVIC-19 clinical trial titled: “Randomized Open-Label Trial of Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19” which investigated the efficacy of early transfusion of very high Ab titre CCP in vulnerable immunocompromised COVID-19 patients. By analysing evidence from clinical trials and controlled access use, WP2 generated high-quality datasets for the EU-CCP database.
· WP 3 participated in the management of the EU CCP database by monitoring the quality, number, structure and completeness of reported data, proposing improvements to the IT tools for accessibility, data upload and generation of common dashboards. WP3 actively engaged with registered BEs to receive feedback on how to facilitate reporting to the database. At the end of the project, WP3 analysed the data in the database resulting in valuable information on the production and use of CCP in Europe that was taken into account in defining the final recommendation of the project.
· WP4 surveyed EBA-affiliated BEs and principal investigators of selected clinical trials about CCP laboratory testing. Based on the survey evaluation, WP4 produced and distributed a pool of centrally prepared and characterized standard CCP samples that allow for the calibration of biochemical and virus neutralization assays, in CCP donors and products. WP4 team demonstrated the linearity of different assays and showed the correlation between biochemical and virus neutralisation assays. The effect of vaccinations and virus variants on antibody content and potency was also analysed and correlated with the clinical status of the patients.
· WP 5 integrated project-generated data, calculated CCP provision costs in the EU, performed a SWOT analysis of CCP use during a pandemic, and formulated three different sets of recommendations on CCP collection, the use of CCP to treat COVID-19 and the use of CCP to treat future outbreaks of SarsCoV-2 or other novel pathogens.
· WP 6 contributed to the project publications and press releases, prepared layman versions of the technical reports, organised meetings and a final meeting-stakeholder conference, interacted with parallel projects and conducted a dialogue with the EU.
· WP7 managed and coordinated the project's financial, administrative and contractual activities to ensure that project implementation was compliant with the conditions outlined in the Grant and the Consortium agreements. In collaboration with other WPs WP7 worked on an adaptation of the project and put together two Amendments to extend the duration of the project.
Consortium members achieved the project objectives by working together within and between WPs.
· WP 1 reviewed and assessed available literature, developed preliminary assessment criteria and guidelines for a high-quality evaluation of clinical trials or monitored access programs for CCP use and continuously followed ongoing clinical trials. Based on these guidelines, WP1 identified several clinical trials eligible for support by the project.
· WP 2 contacted selected trials to verify their availability to collaborate with SUPPORT-E, performed a gap analysis of information in these trials and regularly updated knowledge as new data emerged. To fill the identified gaps, the project consortium decided to financially support the European multicentre COVIC-19 clinical trial titled: “Randomized Open-Label Trial of Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19” which investigated the efficacy of early transfusion of very high Ab titre CCP in vulnerable immunocompromised COVID-19 patients. By analysing evidence from clinical trials and controlled access use, WP2 generated high-quality datasets for the EU-CCP database.
· WP 3 participated in the management of the EU CCP database by monitoring the quality, number, structure and completeness of reported data, proposing improvements to the IT tools for accessibility, data upload and generation of common dashboards. WP3 actively engaged with registered BEs to receive feedback on how to facilitate reporting to the database. At the end of the project, WP3 analysed the data in the database resulting in valuable information on the production and use of CCP in Europe that was taken into account in defining the final recommendation of the project.
· WP4 surveyed EBA-affiliated BEs and principal investigators of selected clinical trials about CCP laboratory testing. Based on the survey evaluation, WP4 produced and distributed a pool of centrally prepared and characterized standard CCP samples that allow for the calibration of biochemical and virus neutralization assays, in CCP donors and products. WP4 team demonstrated the linearity of different assays and showed the correlation between biochemical and virus neutralisation assays. The effect of vaccinations and virus variants on antibody content and potency was also analysed and correlated with the clinical status of the patients.
· WP 5 integrated project-generated data, calculated CCP provision costs in the EU, performed a SWOT analysis of CCP use during a pandemic, and formulated three different sets of recommendations on CCP collection, the use of CCP to treat COVID-19 and the use of CCP to treat future outbreaks of SarsCoV-2 or other novel pathogens.
· WP 6 contributed to the project publications and press releases, prepared layman versions of the technical reports, organised meetings and a final meeting-stakeholder conference, interacted with parallel projects and conducted a dialogue with the EU.
· WP7 managed and coordinated the project's financial, administrative and contractual activities to ensure that project implementation was compliant with the conditions outlined in the Grant and the Consortium agreements. In collaboration with other WPs WP7 worked on an adaptation of the project and put together two Amendments to extend the duration of the project.
The Support-E project advanced knowledge and practice in using convalescent plasma (CCP) for infectious disease outbreaks. It conducted a high-quality evaluation of CCP in COVID-19, developed EU-wide recommendations, and provided evidence that while CCP lacks efficacy in immunocompetent patients, early high-titer CCP can prevent hospitalization or death in immunocompromised patients with mild COVID-19. This evidence-based recommendation may improve quality of life and reduce healthcare costs for this vulnerable group.
The project established guidelines for donor selection, plasma collection, and product testing, ensuring high-quality CCP products while minimizing waste and costs. It also confirmed that pandemic response requires international collaboration and showed the value of a unified EU CCP database, despite challenges in data sharing due to varying interpretations of GDPR.
Additionally, the project’s recommendations can optimize future CCP research, accelerate health policy decisions, and strengthen public trust, potentially supporting economic recovery by enabling faster returns to work.
The project established guidelines for donor selection, plasma collection, and product testing, ensuring high-quality CCP products while minimizing waste and costs. It also confirmed that pandemic response requires international collaboration and showed the value of a unified EU CCP database, despite challenges in data sharing due to varying interpretations of GDPR.
Additionally, the project’s recommendations can optimize future CCP research, accelerate health policy decisions, and strengthen public trust, potentially supporting economic recovery by enabling faster returns to work.