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COVID-19 Convalescent Plasma Transfusion

This page hosts the user interface for the EU database of COVID-19 Convalescent Plasma (CCP) donation and transfusion and guidance for blood services on the collection and use of these donations.

EU CCP Database - COVID-19 convalescent plasma collection and transfusion in the EU

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Enter the platform here

The European Commission is working together with Member States, the European Blood Alliance (EBA), the European Centre for Disease Prevention and Control (ECDC) and other health professionals to support a study of convalescent plasma as a treatment for COVID-19 patients. The study complements the guidance issued by the European Commission and the 27 Member State competent authorities for blood and blood components.

The open-access database will gather and make available data on convalescent plasma donations and patient outcomes following transfusions. It includes data from blood establishments regarding convalescent donors, plasma collection, and plasma components, as well as from clinical trials and from wider monitored use and will consolidate EU evidence on the safety and effectiveness of this therapy.

The database has been developed by the European Commission (DG SANTE, DG DIGIT, and DG CNECT) in collaboration with EBA and will be managed jointly by EBA and the European Commission. If you have questions, please check our FAQ or contact sante-sohoatec [dot] europa [dot] eu (sante-soho[at]ec[dot]europa[dot]eu).

How will the database be filled?

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How can you participate?

Blood establishments

To join the study, blood establishments should first contact the European Blood Alliance (EBA) at infoateuropeanbloodalliance [dot] eu (info[at]europeanbloodalliance[dot]eu). They will then be invited to register their details. Once they have registered, they will then be provided with credentials to access the database and submit donation and transfusion outcome data.

GDPR applies only to the personal data of blood establishment contact persons stored in the database. Data related to donors and patients are not sufficient to identify natural persons. These anonymous data are not subject to GDPR.

Blood establishments store additional information on donors that do allow their identification. They are, therefore, responsible to respect GDPR rules when processing that data within their own centre databases. If they also hold identifiable data on transfused patients, they are similarly responsible for compliance with GDPR in that respect. Their databases are not linked to the EUCCP platform.

Clinicians / hospitals

Clinical Users (from Clinical Trials/Studies or Monitored Use Programme) may also enter transfusion and clinical outcome data. This should be done (where possible) in consultation with the supplying Blood Establishment.

Clinical Users should first contact the European Blood Alliance (EBA) at infoateuropeanbloodalliance [dot] eu (info[at]europeanbloodalliance[dot]eu). They will then be invited to register their details. Once they have registered, they will then be provided with credentials to access the database and submit transfusion and outcome data.

GDPR applies only to the personal data of blood establishment contact persons and clinical users stored in the database. Data related to donors and patients are not sufficient to identify natural persons. These anonymous data are not subject to GDPR.

Clinical Users store additional information on transfused patients that do allow their identification. They are, therefore, responsible to respect GDPR rules when processing that data within their own centre databases. Their databases are not linked to the EUCCP platform.

Donors

If you are a recovered COVID-19 patient, your plasma contains antibodies that may be transfused to patients to help fight the disease that causes the illness. If you would like to know more about donating convalescent plasma, please contact your blood donation service to know whether they are participating in this initiative.

Researchers

If you are interested in using the data that is aggregated here, please note that general results will be openly available on this webpage as they are analysed. It may also be possible for the European Commission to run specific queries on request.

Technical Information on the data collection for Blood Establishments and Clinical Users

The data collection comprises three modules:

  1. Blood Establishment Registration module: Blood Establishments need to complete the registration module ONCE to participate in the EU CCP Database. (Privacy statement).
  2. Clinical User Registration Module: Clinical Users need to complete the registration module ONCE to participate in the EUCCP Database. (Privacy Statement).
  3. EUCCP Database: Once registered, Blood Establishments may enter CCP donation and CCP Transfusion and Outcome Data into the EUCCP Database. Similarly, once registered, Clinical Users may enter transfusion and outcome data into the EUCCP Database. It is recommended that Clinical Users liaise with the Blood Establishment that has supplied CCP in relation to data entry to the EUCCP database to avoid duplication of effort. Please note that the Donation Identifier serves as the link between the CCP donation and the transfused patient . Please also note that it is possible to update information (e.g. laboratory results) entered over time.

Should you have technical questions, please contact CEF-BDTI-SUPPORTatec [dot] europa [dot] eu (CEF-BDTI-SUPPORT[at]ec[dot]europa[dot]eu).

Results

Aggregated standard reports will be available here as the project progresses. The data will be analysed by the EBA using the Big Data Test Infrastructure (European Commission, DG Connect).

Guidance on the collection and transfusion of convalescent COVID-19 plasma

Plasma transfusion is a potentially promising therapy for COVID-19 patients that can be made widely available at relatively short notice by blood services across the EU.

A Guidance document on the collection and transfusion of convalescent COVID-19 plasma was first published in April 2020, with several updates later on (the last one in March 2021). A revision of the guidance is ongoing.

The guidance aimed to facilitate a common approach across EU Member States to the donation, collection, testing, processing, storage, distribution and monitoring of convalescent plasma for the treatment of COVID-19 patients.

The guidance, which is not legally binding, was developed in collaboration with the European Centre for Disease Prevention and Control (ECDC) and is endorsed by the 27 Member State competent authorities for blood and blood components.

In collaboration with the European Blood Alliance (EBA), the European Commission (DG DIGIT) is building a database for the collection of data on donation and patient outcome. The database went live in April and is open to all EU/EEA blood establishments that wish to participate, via the EBA.

This open-access database will gather data from monitored use, as well as from randomised clinical trials, and will consolidate EU evidence on the safety and effectiveness of this therapy.

Blood Services in EU/EEA countries that wish to participate in the EU donation and outcome monitoring programme should contact EBA at infoateuropeanbloodalliance [dot] eu (info[at]europeanbloodalliance[dot]eu)

More EBA information:

Emergency Support Instrument strengthens blood service capacity for collection of COVID-19 convalescent plasma (CCP)

The Emergency Support Instrument (ESI) helps EU countries in their efforts to address the coronavirus pandemic. It responds to needs that can be best addressed in a strategic, coordinated manner at European level. As a financing arm of the Joint European Roadmap towards lifting coronavirus containment measures, the instrument helps mitigate the immediate consequences of the pandemic and anticipate the needs related to the exit and recovery phases.

ESI is being used to facilitate urgent and efficient increases in blood establishment capacity for collection, storage and testing of CCP for the above mentioned purposes. It is to be achieved through investment in equipment and other associated needs.

The Commission awarded 20 grants for a total of €22.5 million that were used to build new programmes, or expand existing ones, for the collection of plasma from donors recovered from COVID-19. The beneficiaries blood services in 13 EU countries and the UK, are national or regional and local blood or plasma collection centres (over 150 in total).

Concretely, the ESI funding has supported the purchase of a number of plasmapheresis machines and associated equipment, including collection kits, storage equipment, laboratory testing and characterisation of plasma and organisational changes within blood centres. A snapshot of the results achieved through ESI funding is available in this infographic.

Background information on COVID-19 Convalescent Plasma

A treatment with a promising benefit/risk ratio

Transfusing plasma from patients that have recovered from infections has been tried in the past with some success. For COVID-19, this approach is supported by early scientific evidence and a study conducted in Hong Kong during the SARS-1 crisis (a closely related virus). This empirical evidence also indicates that associated risks are very low. In fact, the procedure is a standard plasma transfusion, where the plasma meets all criteria for safety.

In addition to direct transfusion, convalescent plasma can also be used as the starting material for later industrial manufacturing of specific immuno-globulins (medicinal products). The development of such industrially manufactured product would be enhanced by the availability of a substantial inventory of donated convalescent plasma, meeting high standards of quality and safety.

Widely available in a short time

Convalescent plasma transfusions can be made available in the short term through the existing organisational capacities in the public/NGO blood services in the EU Member States. In more than half of EU Member States, blood services are preparing for collection. In some EU Member States the collection and supply has already started.

The extensive potential donor pool, recovered COVID-19 patients, seems highly motivated to donate and help fellow citizens.

This possible therapy is also of high interest across the world, and in the US FDA is already approving individual applications for use of convalescent plasma for specific patients and is working with the American Red Cross blood centres and the Mayo Clinic to support an ‘expanded access’ programme.

Working together to follow up transfused patients across the EU

Although the plasma itself is a normal donation and blood component, the effectiveness of using it to treat patients with COVID-19 infection is unproven. Through the collaborative efforts of the European Commission, the Member State competent authorities for blood and blood components, the European Centre for Disease Prevention and Control and the European Blood Alliance, data will be gathered and analysed in a common database so that a clear picture emerges on the usefulness of these promising transfusions.

In the interests of transparency and knowledge sharing, the database will be open access.

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