About

CCP
CCP stands for Covid-19 Convalescent Plasma, plasma collected from Covid-19 recovered patients. CCP contains antibodies that could neutralize SARS-CoV-2 and thus may improve disease course in patients with SARS-CoV-2.

 

SUPPORT-E Project: Severe acute respiratory syndrome virus 2 (SARS-CoV-2), responsible for COVID-19, has spread worldwide and has provoked a global health crisis.

 

To date, there are no direct viral medicinal products for the treatment of SARS-Cov-2. Only experimental drugs, associated to support care, are available as well as monoclonal antibodies, which are specifically used for the treatment of at risk patients such as those immunocompromised.

Hence, despite all, there is still a need for new curative strategies that preferably have already been used in clinical practice and that are widely available and scalable. Based on clinical experiences from previous epidemics, the use of convalescent plasma from recovered Covid-19 patients has been used producing still controversial results.

 

Therefore, successful adoption of this strategy in clinical practice in Europe still requires extensive clinical testing and would benefit from a coordinated approach between Blood Establishments (BEs), clinical centres and competent authorities across Europe to support and accelerate high-quality evaluation of CCP for the future.

 

In this context, the formulation of recommendations based on scientific and clinical insights coming from newly developed standardized assays and evaluation of CCP donor and recipient data will be of paramount importance.

What is COVIC-19?

COVIC-19 is a randomized controlled clinical trial that meant to evaluate, with the highest scientific standards, the effectiveness and safety of CCP (COVID-19 Convalescent Plasma) as early treatment in immunocompromised COVID-19 patients.

 

The study, supported by the SUPPORT-E project, addresses the knowledge gaps identified by the project, whose team selected more than 700 relevant articles by reviewing tens of thousands of published clinical trials and monitored access programs and scientific articles. They conducted a thorough analysis and assessment of strengths and weaknesses of these studies and evaluated the data provided by the European CCP Database. In 2022, the COVIC-19 trial was initiated in France, Germany and the Netherlands.

The trial enrolled 120 patients who met the following criteria: they had a confirmed COVID-19 infection, belonged to the category of vulnerable patients (such as those who are immunocompromised), did not require hospitalisation, and could start treatment within 7 days of a positive screening test.

 

The objective of COVIC-19 is to investigate whether a therapy based on CCP with the high antibody titers will reduce the risk of death or hospitalisation in this group of patients. The findings from the study will ultimately contribute to the overall assessment of the clinical effectiveness of CCP. This information will be valuable in determining the use of convalescent plasma as part of a coordinated approach for treating new infections with pandemic potential in the future.

Objectives

I

Support High Quality
CCP donation

II

Support High Quality CCP Evaluation in clinical trials and monitored access use programmes

III

Deliver Recommendations for the collection and use of CCP in EU member states to treat Covid-19

IV

Deliver Recommendations for future outbreaks

V

Ensure EU wide adoptions of recommendations and project legacy