SUPPORT-E releases new video presenting the activities of Work Package 2 on clinical trials
New video from SUPPORT-E: presenting the project and work package 1
The European project SUPPORT-E (SUPPORTing high-quality evaluation of COVID-19 convalescent plasma throughout Europe) was signed at the beginning of September 2020 by the European Blood Alliance (EBA), coordinator of the project and the European Commission, Directorate-General for Research and Innovation.
In the absence of validated treatment for COVID-19, this pan-European initiative is unique as it assesses at EU level the potency of COVID-19 Convalescent Plasma (CCP) to treat patients with COVID-19, through clinicals trials supported via this project. It will allow healthcare and policy makers to include or not CCP as a treatment within therapeutically options, based on sound science and evaluation.
Coronavirus disease (COVID-19), caused by acute respiratory syndrome virus 2 (SARS-CoV-2) has provoked a global health crisis. To date, very limited specific antiviral treatment options have been proven effective and no vaccine is available. Therapeutic options for COVID-19 mainly focus on supportive care. Hence there is a need for new curative strategies that preferably have already been used in clinical practice and are widely available and scalable. Based on clinical experiences from previous epidemics and recent observational data, the use of convalescent plasma from recovered COVID-19 patients may provide a therapeutic solution. Successful adoption of this strategy in clinical practice still requires extensive clinical testing and would therefore benefit from a coordinated approach between blood establishments and clinical centres across EU Member States (and the UK) to support and accelerate high-quality evaluation of COVID-19 convalescent plasma (CCP) .
The SUPPORT-E project is funded by the European research programme Horizon 2020 for at total of 4 million Euros and will last for 24 months. Up to now, a Status Report on EU and International ongoing and upcoming clinical trials and a preliminary guidance document with assessment criteria for clinical trials have been produced. These documents lay down the foundation to efficiently achieve the other very challenging goals as scheduled.
|Participant No||Participant organisation name||Participant short name||WP||Country|
|1||European Blood Alliance (Coordinator)||EBA||WP7|
|2||Établissement Français du Sang||EFS||WP3, WP5||France|
|3||DRK Blutspendedienst Baden-Württemberg-Hessen||DRK- BSD||WP2||Germany|
|4||Stichting Sanquin Bloedvoorziening||SAN||WP4||The Netherlands|
|6||Aarhus University Hospital||AAR||WP3||Denmark|
|7||Istituto Superiore Di Sanita -CNS||ISS-CNS||WP2||Italy|
|8||Fondazione irccs policlinico san matteo||SMATTEO||WP2||Italy|
|9||Azienda Socio Sanitaria Territoriale (ASST) di Mantova||ASST MANTOVA||WP6||Italy|
|10||National Health Service Blood and Transplant||NHSBT||WP5||UK|
|11||Statens Serum Institut||SSI||WP3||Denmark|
|12||Blutspende SRK Schweiz AG||SRK||WP2||Switzerland|
The project will be developped through seven work packages:
WP1 Assessing CCP, conducting clinical evaluation and defining best practices
1.1 Assess upcoming and ongoing clinical trials (survey)
1.2 Produce preliminary clinical trial guidelines and assessment criteria
1.3 Produce preliminary monitored access guidelines
1.4 Monitor upcoming and ongoing clinical trials
WP2 Supporting high-quality clinical evaluation and producing datasets for inclusion in the database
2.1 Include selected clinical trials and monitored access programmes in SUPPORT-E – feasibility
2.2 Provide funding for selected clinical trials with limited own resources
2.3 Ensure high-quality dataset accrual in the database
2.4 Interact with different stakeholders to promote high-quality clinical evaluation of CCP and
generate novel clinical data
2.5 Enable interactions between clinical trial groups and reference labs on SARS-CoV-2 antibody
2.6 Undertake further analysis on CCP collection and use
WP 3 Collecting, monitoring and analyzing EU-CCP database data
3.1 Govern the database
3.2 Collect data and monitor real-time data accrual
3.3 Analyse data
WP4 Improving plasma potency assessment
4.1 Facilitating anti-SARS-CoV-2 antibody testing
4.2 Access and cross-border standardisation of PRNT testing
4.3 Compare commercially available assays to PRNT and/ or MN
4.4 Characterise antibody content
WP5 Developing recommendations and preparing for the future
5.1 Integrate all project-generated information
5.2 Conduct cost benefit analysis
5.3 Perform SWOT assessment to support future SOHO development
5.4 Develop recommendations for CCP collection
5.5 Develop recommendations for CCP use to treat COVID-19
5.6 Develop recommendations for future outbreaks of SARS-CoV-2 or other novel pathogens
WP6 Dissemination, exploitation and communication
6.1 Develop Dissemination and Exploitation Plan and dissemination material
6.2 Contribute to publications and press-releases
6.3 Draw up layman versions of the Technical Reports
6.4 Organise of a Final Meeting – Stakeholder Conference
6.5 Interact with parallel projects and conduct dialogue with EU
WP7 Project management
7.1 Coordinate project
7.2 Manage project
7.3 Manage administration and finance
Three integrated elements: Assessment (1), Support (2, 3, 4) and Recommendation (5 and 6)
A Preliminary guidance document is delivered (1) which is then used to select trials and programmes for project inclusion (2).
The Blood Establishments (red circles), clinical trials (light blue circles) and monitored access programmes (dark blue circles) enter donor/recipient data into the database (3).
Additional funding is attributed to clinical trials if warranted (2), interaction with groups(2) is key for data analysis.
Data is collected in the database and monitored (3).
Plasma anti-SARS-Cov-2 Ab testing and profiles are characterised (4) and assessed for donor-recipient correlations (2,4).
All generated assessment results are integrated and the use of CPP is evaluated in terms of safety and efficacy and costs and benefits (5).
Based on the lessons learned, recommendations are developed and disseminated for CCP collection, testing, and use in the current pandemic and future outbreaks of SARS-CoV-2 or novel pathogens (5,6).
Watch this video for more information:
More information: info (at) europeanbloodalliance.eu