The global healthcare company is the first private partner to take advantage of the Perpetual Observational Study on Acute Respiratory tract Infection in Primary Care (POS-ARI-PC), part of the EU-funded ECRAID-Base project. Data from patients consulting their GP with respiratory infection symptoms will be used to inform Sanofi’s vaccine development for older adults.
Respiratory viruses seriously impact public health, especially during the winter season. Most viral respiratory infections can initially present like a common cold. But unlike a cold, some viral infections can progress to become a serious lung infection and cause complications such as pneumonia, and even death, particularly in high-risk patient groups. Safe and effective vaccines are available for some respiratory viruses such as influenza and COVID-19, but there are still several viruses for which no licensed vaccine exists.
Sanofi, an innovate global healthcare company, is pursuing the development of new vaccines against respiratory viral targets such as RSV, human metapneumovirus and parainfluenza virus. Generating high-quality and granular data on the epidemiology and impact of these viruses are key components of the development activities.
This is where the University of Oxford-led perpetual observational study will play a role. Its objectives include providing critically important benchmark descriptive data related to patient characteristics, complications, outcome, and risk factors per viral aetiology. For this study, a number of additional indicators will be added via an amendment to the POS-ARI-PC master study protocol.
The focus will be on patients over 60 years of age, as they are generally more vulnerable to complications following an acute respiratory infection (ARI). Data will be collected from primary care practices in several European countries. The study will include patients over 60 presenting to their general practitioner with symptoms of an ARI. Viral aetiology will be determined, and patients will be followed up for a month to track key indicators, such as course of symptoms, recovery, quality of life, complications, health care attendance.
POS-ARI-PC PrincipaI Investigator Chris Butler, Clinical Director of the University of Oxford Primary Care Clinical Trials Unit, is enthusiastic about this private-public research collaboration:
"The far-sighted funding from the EU for this important perpetual observational research is advancing science in the field of ARI in the community in its own right. It is in the community where most people with respiratory infections are cared for and so it is a natural choice for studying new approaches to prevention and treatment. I find it particularly appropriate and historic that an industry leader like Sanofi is joining forces with primary care to work together to bring a promising prevention solution to those who need it the most.”
Coordinating Investigator Alike van der Velden, assistant professor at the University Medical Center Utrecht, is equally excited about seeing the study platform edging closer to realising its potential:
“Working together with Sanofi on adapting the master study protocol to additionally capture elements essential to their research goals was inspiring and quickly resulted in the Sanofi Study Specific Appendix. This confirms that the basic structure of our platform study for ARI in primary care is indeed able to rapidly adapt to new needs and research questions.”
Bogdana Coudsy, Head of Global Medical, Vaccines, Sanofi, adds:
“We are very pleased to initiate this research collaboration with Ecraid utilising the POS-ARI-PC platform. Partnerships such as this are a cornerstone of our evidence generation activities, and this important project will support our efforts to better understand the impact of respiratory viruses in the older adult population.”
POS-ARI-PC is a multi-country, prospective perpetual observational study (POS) among patients presenting in primary care with acute respiratory tract infections (ARI). Next to providing critically important benchmark descriptive data, the study aims to establish a research-ready infrastructure for enhanced observational studies and clinical trials related to treatment, diagnosis, and prevention of ARI in the primary care setting. This “plug-in” approach makes it possible to set up new studies much quicker, without having to go through the full process of regulatory approvals for each individual research.
The study is being conducted under the ECRAID-Base project which has received funding from the European Union’s Horizon 2020 research and innovation programme (Grant Agreement No. 965313).
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