BioResource-supported COVID study concludes patient recruitment, breaking target of 800

In late October last year, the COVID-19 Clinical Neuroscience Study (COVID-CNS) rounded off a busy 18 months of consenting and collecting data from participants, with a final total of 818 people across the UK joining this study looking at neurological or neuropsychiatric complications of COVID-19.  

COVID-CNS LOGO

A neuroscience collaboration 

COVID-CNS is a UKRI-funded collaborative study jointly led by experts in neuroscience and psychiatry based at the University of Liverpool and King’s College London, and is part of our COVID-19 BioResource. The study recruited patients who were either: 

  • admitted to hospital with COVID-19 and had neurological or neuropsychiatric complications,
  • admitted to hospital but without experiencing these symptoms,
  • admitted to hospital with neurological or neuropsychiatric complications after receiving a COVID-19 vaccination,
  • or healthy controls (without COVID-19).  

The aim is to understand how these complications occur, why they occur in some patients and not others, and to develop strategies to prevent and treat them.

For more information, you can download the COVID-CNS Study Booklet.    

National recruitment

In total 17 NHS institutions in ten English cities, plus Cardiff, consented patients from local clinics to take part, with over half coming from King’s College Hospital and the two Liverpool sites (see image below).  

Map of COVID-CNS recruitment sites in England and Wales

Once an eligible patient has been identified and has consented to take part in the study and to join the NIHR BioResource volunteer panel, they donate a biological sample, complete several assessments, and a health and lifestyle questionnaire. If willing, patients also have an MRI scan; a key tool for assessing whether neurological or mental health difficulties are due to changes in the brain as a result of COVID-19. 

All participants are then invited to complete follow-up assessments approximately three times in the following 18 months, either online or over the phone where necessary. 

As an observational study, no diagnosis, medication or other therapy is provided to participants. Each volunteer is kindly taking part in a bid to support research efforts for all, rather than purely their own health journey. Without such volunteers, COVID-CNS and the NIHR BioResource does not function.  

Of the 818 COVID-CNS participants, 61% identified as male and 38.1% as female, with a mean age of 54.7.  

One of the study’s key aims was to reach under-represented and marginalised groups, including socio-economic and ethnically diverse participants. 75.7% of participants self-reported White, 10% Black, 3.1% Asian, 3.3% Mixed and 7.9% ‘Other’.

Co-Principal Investigators Professor Benedict Michael and Professor Gerome Breen feature alongside COVID-CNS study collaborator Dr Tim Nicholson in this short video explaining the study design and objectives:

In a bid to support the various accessibility requirements that present when approaching research participation, the study team included an aural consent option for the visually impaired, evening sessions to fit around work, covering travel expenses, and phoning participants at home to complete online questionnaires if internet access was unavailable. 

Involvement of the NIHR BioResource 

This study is an integral part of the NIHR BioResource, using COVID-19 BioResource governance and research framework, as well as the infrastructure for sample processing to speed up clinical research and clinical trials. Patients recruited to COVID-CNS are consented to the NIHR BioResource and will be re-contactable to participate in further research, following standard protocols for being a BioResource volunteer. 

Professor Gerome Breen, co-Principal Investigator and lead for our Mental Health BioResource commented:

"This has been a wonderful project, the largest study of severe brain effects of COVID-19 in the world, thanks to a collaboration of hundreds of neuroscientists across the UK throughout the pandemic with the collaboration of the NIHR BioResource enabling us to bring it all together."

 

Hear directly from some of the study participants regarding their experience of taking part and motivations for doing so in this short testimonial video.

Patient and Public Involvement (PPI)

Throughout the initial design phase and the participant recruitment period, COVID-CNS has worked closely with their PPI panel. The panel play a vital role in bringing the patient perspective to discussions and highlighting any areas they feel need greater scrutiny, such as the requirements of participants when taking part, or reviewing study materials and information before distributing to participants.

The panel is chaired by Dr Ava Easton, CEO of the Encephalitis Society and includes several of the research team and clinicians. Several patients from the study were invited to sit on the panel, and you can learn a little more about three of them and view the full panel member list on the study website PPI page

The COVID-CNS team would like to extend a huge thanks to the panel for their continued contributions to getting the study to this point, and look forward to working with them as the study enters the next phase.

Outputs and Data 

With the recruitment of new patients to the study now closed, the COVID-CNS team, made up of experts from across six core areas relating to brain complications from COVID-19, will continue to study the data and samples collected from volunteers to further their understanding of the neurological or neuropsychiatric complications arising from COVID-19. All outputs and publications are included on the study website, along with other news related to the study. 

Furthermore, as COVID-CNS is part of the NIHR BioResource, data will be available on application for researchers outside of the core study team. Anyone interested in applying to access COVID-CNS data will need to complete a BioResource Data Access Application Form.  

What’s next? 

Moving forward, the team are keen to build on their work and establish a longitudinal study over 3-5 years, looking at who develops central nervous system complications at the time of having COVID-19, how these complications occur and what they mean for brain recovery on the aging brain. Ultimately the identification and development of potential new treatments is a key objective of this work, knowing the impact COVID-19 and long COVID is having on millions globally. 

Whilst our COVID-19 BioResource is no longer actively recruiting COVID patients, data, samples and recall of the 8,000 who have already joined, including 818 via COVID-CNS, are accessible by researchers upon application to the BioResource. 

Acknowledgements  

The COVID-CNS team and the BioResource would like to offer our sincere thanks to the 818 participants who gave up their time to participate and attend their local hospital for a study visit, and to attend follow-up sessions in the future. Please keep an eye on the Outputs page on the COVID-CNS website to stay up to date with the research you have contributed to and COVID research in general. 

This study was also made possible thanks to the recruiting teams across the country who diligently identified, consented and followed up with each participant to ensure an enjoyable, efficient and rewarding experience for all participants.  

If you have any questions, please continue to contact the study team at covidcns@kcl.ac.uk. You can also follow the study team on Twitter @covidcns for any updates on the study. 

If you are interested in working with the NIHR BioResource to support your research, please get in touch. If you are interested in volunteering with the BioResource to be part of future research we support, we’d love to hear from you. 

You can keep up to date with the NIHR BioResource on Twitter and LinkedIn. 

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