ECRAID-Prime: Sharing Learnings from Decentralised Trial Elements

With the first study of the ECRAID-Prime adaptive platform trial now closed, our national coordinating teams across Europe are reflecting on what it means to run this clinical trial in practice, also deploying hybrid and decentralised recruitment and follow-up procedures.

Beyond launching Europe’s first adaptive platform trial in primary care for respiratory infections, the EU-funded ECRAID-Prime trial also tested how clinical research could operate in a complex, real-world and multi-country setting during infectious disease outbreaks. 

Overcoming Recruitment Challenges

The Phase 2B study comparing Nitric Oxide Nasal Spray with saline nasal spray and saline nasal spray with usual care began enrolling patients at the end of 2024 and was quickly confronted with a core recruitment challenge: time. Participants were only eligible for the study within a narrow 2 – 3-day window from symptom onset. At the same time, care-seeking behaviour varies widely across countries, with many people experiencing cold or flu symptoms no longer contacting their general practitioner (GP) and managing their symptoms at home or with over-the-counter medication, or only visiting their GP if their symptoms are very severe or longlasting. This reality meant that traditional, site-based recruitment alone was simply not enough. 

Our national coordinating teams responded with a flexible, patient-centred approach, adapting processes to meet patients where they were and within the narow eligibility window. Despite these challenges, from October 2024 to March 2026, more than 811 participants were enrolled in eight countries.

Looking back on their experiences in conducting this first-of-a-kind trial, they reflect on both their learnings and the strong commitment behind these efforts:

🇩🇪 Germany: Home-based participation and strong engagement  

“We’re proud of enrolling participants from the comfort of their own homes. This makes participation easier and more accessible while also increasing patient adherence through a personal connection with our participants. We’ve also experienced remarkable hospitality from people who are sick with a respiratory infection.”

They noted that taking part from home was especially appreciated. With participants finding the study diary easy to complete. While some were less enthusiastic about follow-up calls or reminders – particularly once they had recovered –, everyone understood that these were necessary.

“Overall, participants were highly engaged and motivated to contribute and have a genuine interest in advancing research – especially because these illnesses are so common and burdensome!”

- Alexander Nicolas Schwager, Medical Doctor at the University Hospital Würzburg

🇬🇧 United Kingdom: Rapid implementation of remote recruitment 

From the UK, our team based at the Primary Care Clinical Trials Unit at the University of Oxford highlighted the successful implementation of remote participant recruitment as a key factor for boosting overall enrolment.

“We are very pleased and proud to have successfully implemented remote participant recruitment for ECRAID-Prime in the UK within a short timeframe. This approach proved highly effective, enabling us to make a meaningful contribution to the overall recruitment total.” 

They also described the learning curved involved and the importance of adapting quickly: 

“We’ve learnt – sometimes the hard way – what works, what doesn’t, and what can be improved for the future. We look forward to sharing our experience and knowledge with other teams so that we can go bigger and better next time!” 

Looking ahead, the team hopes to continuously improve their decentralised pathways, and streamline processes and procedures, and expand access to more marginalised participants. They also expressed gratitude to their participating GP practices and site staff.  

“Recruitment was challenging due to the short symptom window, yet most sites managed to recruit at least one participant, which is a testament to their commitment.” 

- Emma Harper 
Trial Manager at the Primary Care Clinical Trials Unit, University of Oxford 

🇫🇷 France: Mobile units bringing trials closer to patients

Our French team at CHU Limoges’s Clinical Investigational Center focussed on adapting their recruitment strategies to better meeting both their GPs’ and participants’ needs, including the deployment of a mobile medical unit.

“To further boost our impact, we introduced a mobile medical unit, allowing us to meet patients where they are and facilitate immediate enrolment right after their GP appointment. Thanks to this unit, we enrolled 2 additional patients in the last week of the study!”

They highlighted the broader potential of this approach: “The positive results achieved with our mobile unit highlighted a major opportunity for the future. Our goal is to see decentralised recruitment become the norm in primary care and for community care. These tools are essential for streamlining inclusion and making clinical trials a seamless part of the medical consultation.”

Meanwhile, participants expressed high satisfaction with their involvement in the study: 

“They especially appreciated the regular follow-up calls and interactions, which made them feel genuinely supported and well-cared for throughout the process!”

- Elodie Pfender
Co-head at the Clinical Investigational Center, CHU Limoges 

Key insights at a glance

Blueprint for future studies

The NONS/saline study has now closed, but it leaves behind more than valuable data. 

The ECRAID-Prime trial has demonstrated not only its scientific value but also its ability to rapidly mobilise, execute, and generate high-quality clinical research in real-time. But more importantly, it offers a blueprint for the future. It demonstrates what can be achieved through strong international collaboration and provides a practical framework for future hybrid and decentralised trials.

The ambition is to continue building on this platform and our primary care clinical research network to remove the need to establish new standalone trials in the future and enabling faster, more connected clinical research across Europe. 

More information

Learn more about ECRAID-Prime trial on https://ecraid.eu/ecraid-prime/studies.