ECRAID-Prime is one of six projects selected by the European Commission's Horizon Europe program to drive vaccines and therapeutic clinical trials to boost COVID-19 prevention and treatment. ECRAID-Prime will implement Europe’s first adaptive platform trial on new treatments for COVID-19 and COVID-like illness in the community and consolidate years of EU-funded efforts to build a clinical research infrastructure in primary care.
When the novel coronavirus epidemic first broke in Wuhan, China and spread globally, the world was thrown into disarray as sickness, rising death tolls and lockdown restrictions permeated our daily lives.
Though many of us can vividly recall our pandemic memories, our “how we first knew” moments are hazier. For Alike van der Velden, it was sometime at the end of January 2020, when the first confirmed cases were emerging outside of China.
From outbreak to pandemic
Until then, Alike who is an Assistant Professor at the University Medical Center Utrecht (UMCU) in the Netherlands, was still hopeful and confident that “we as a country, government, hospitals and medical science, would be able to manage this outbreak”.
She recalls, “It struck me one evening when I was at home with my daughter. We were watching the news on TV when she turned to me and whispered, ‘Mum, I’m frightened. Could you please hang the Christmas star up again? The world needs some hope to fight this pandemic.’ At that point, it really struck me that others had very different emotions, and the magnitude of this fear was real.”
The rest, as they say, is history. Within the first two years of the COVID-19 pandemic, more than 450 million cases were reported globally, of which over 100 million were in Europe.*
Evaluating early treatments in the community
Alike works at UMCU’s Julius Centre for Health Sciences and Primary Care and her research focusses on respiratory infection and the appropriateness of prescribing medication in primary care. More than 10 years ago, she began developing a primary care research network as part of the EU-funded PREPARE and VALUE-Dx projects, which included treatment and diagnostic clinical trials for outpatients with respiratory infections.
Today, Europe’s primary care research network encompasses more than 250 general practitioners in 20 European countries. The network will continue to expand and professionalise its clinical research capabilities within Ecraid. The goal to optimise healthcare delivery and accelerate the introduction of new treatment and diagnostic solutions.
In May 2021, Alike received a call from Herman Goossens, whom she works closely with on many EU-funded projects. She recalls, “When Herman called to discuss applying for EU-funding for a new project – one solely focussed on primary care to evaluate new treatments for the early treatment of COVID-19 in the community, I felt a surge of excitement. I was proud that our European primary care network of national coordinating teams and their general practices would have a vital role to play in fighting the current pandemic and potentially, future outbreaks.”
This led to the launch of ECRAID-Prime in December 2021. As co-coordinator of the EU-funded project, Alike’s challenge is to implement and embed Europe’s first adaptive platform trial on therapeutics for COVID-19 and COVID-like illness in the primary care network through collaboration with teams at UMCU, Ecraid and the national coordinating teams in seven countries.
Pandemic lessons for the future
The COVID-19 pandemic has revealed major deficits in our preparedness for a viral attack, for example, research fragmentation and the focus on primary healthcare as a key provider of essential services during an outbreak.
"Pandemic preparedness and response require a well-coordinated, whole-of-society approach," says Alike. She elaborates, “Within clinical research, we’ve learnt that the smaller, single-country trials often didn’t come up with conclusive answers, and that it took substantial time to gain approvals and establish structures for the efficient implementation of trials.”
There were also implementation challenges. “At the onset of the pandemic, there was huge pressure on general practitioners, as well as unprecedented care restrictions. This meant that even though we were able to rapidly implement observational studies in primary care in the first phase of the pandemic, we were not yet ready to start a medication trial.”
"A sustainable, continuously active research infrastructure is one of the key pillars to pandemic preparedness. If we can streamline the processes, we will be able to roll out research and clinical trials in a faster and more efficient manner. This will help to generate evidence for useful diagnostics and treatments within a shorter time and minimise the research burden on patients and healthcare workers,” she adds.
Making headway: ECRAID-Prime’s first compound evaluation
The ECRAID-Prime is highly motivated and currently working diligently on their goal to develop a clear and focused master research protocol, while keeping it flexible and adaptable to changes. The project recently selected its first intranasal agent for evaluation and is currently writing the first intervention-specific appendix together with the drug company.
This first agent has undergone evaluation by the independent Joint Access Advisory Mechanism (JAAM), which has concluded that the agent has potential to be useful in primary and community care. The criteria include safety, production scalability and affordability, as well as the ability to decrease illness duration and viral transmission. More information will be shared in the coming weeks.
Alike concludes, “Nowadays, we must learn how to deal with SARS-CoV-2 and realise that it is here to stay. By the farsighted vision of the EU, we will be setting up an adaptive platform trial to find effective treatments for COVID-19, COVID-like illness and other respiratory illnesses that have epidemic or pandemic potential in the future. When this platform trial is active, we will be ready for the next outbreak.”
“This gives me a huge amount of hope for the future,” she says with a huge smile.
Left: Alike's Christmas tree star is now a permanent fixture in the hallway of her home.
Alike van der Velden is assistant professor at the University Medical Center Utrecht in The Netherlands. Alike studied biology at Utrecht University and later attained a PhD in molecular biology. She switched careers in 2003 to medical science and her research focus is on respiratory infection and the appropriateness of prescribing medication in primary care. She has conducted, supervised and collaborated in several successful intervention trials in the Netherlands and Europe on the enhanced and prudent use of antibiotics.
Alike is part of the core team who designed, organised and analysed the primary care trials within the PREPARE and VALUE-Dx consortia, and she co-leads the primary care studies in RECOVER and ECRAID-Base. In addition, Alike manages the European primary care research network.