ECRAID-Prime is an intricate study aimed at addressing a crucial gap in clinical trial capability within Europe. It is of utmost importance to enhance research capacity for prompt implementation and continuous evaluation of therapeutics for infectious diseases, including pandemic and epidemic infections, through a multi-country approach that enables therapeutic trials in the community. A community-based platform for trial capability aligns best with this requirement. However, designing, gaining approval for, establishing and implementing such a trial is a complex and challenging endeavour. It took 2 years to get full ethical and regulatory approval for the ECRAID-Prime master protocol and the first three intervention-specific appendices, with all the accompanying patient-facing materials and other trial related documents and systems, such as case report forms, databases, data and sample management plans, and the statistical analysis plan. With an approved master protocol, trial documents and procedures in place and team experience, it only took 2 months to have the 4th ISA approved. Moreover, with master agreements with NCT organisations and sites in place, initiating the LTX-109 evaluation was not hampered by legal procedures.
To be able to bring the trial to the intended use group population, a decentralized recruitment approach was approved and set up in the UK. This essential step was taken as patients with respiratory illness are increasingly advised to stay at home and not consult their clinician, which will even be reinforced more during a next pandemic. With the UK as prime example and with ICH-GCP and the EMA endorsing these strategies, ECRAID-Prime’s ambition is to implement alternative recruitment strategies in more countries.
In November 2024, the first patient was recruited into the trial in France and sites in all other countries, UK, Ireland, Belgium, Spain, Germany and Poland opened for recruitment. By the end of the third reporting period, 514 participants have been enrolled in the NONS/Saline/usual care and 22 in the LTX-109 evaluation.
These advancements have brought us significantly closer to achieving the urgently needed capability for Europe, which stands as a crucial component of our research efforts and, indeed, our preparedness for pandemics and epidemics. The main impact thus far from ECRAID-Prime is, therefore, a well-organised, recruiting primary care research infrastructure in eight countries, thereby adding to epidemic and pandemic preparedness.
