Blood, tissues, cells and organs

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

Click on the image above to enter the platform

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-soho@ec.europa.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 info@europeanbloodalliance.eu. They will then be invited by the Commission to register their details and to submit donation and transfusion outcome data via the database.

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

If you would like to participate in the study of convalescent plasma, please contact your local or national blood establishment, the usual supplier of blood components for transfusion to your clinic/hospital. Your blood establishment will also ask you for data on transfusion and clinical outcome. They will take care of entering them into the registry.

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.

The data collection comprises three modules:

  1. Blood Establishment Registration module
    Initially, each Blood Establishment needs to complete the registration module ONCE to participate in the EU CCP programme (Privacy statement).
  2. CCP collection module
    This module includes data on donations and should be completed for each CCP collection performed. You can re-enter the module to update information (e.g. laboratory results) over time.
  3. CCP transfusion and outcome module
    This module includes the outcome data from the treatment and should be completed for each CCP transfusion performed, based on data received from the clinician/hospital. You can re-enter the module to update information (e.g. laboratory results) over time.

Should you have technical questions, please contact CEF-BDTI-SUPPORT@ec.europa.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.

The Guidance document on the collection and transfusion of convalescent COVID-19 plasma (the guidance was first published on 8 April 2020 and an update, Version 2.0, was published on 22 June 2020) aims 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 info@europeanbloodalliance.eu

More EBA information:

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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