Inflammatory Bowel Disease Study Seeks CLARITY on COVID-19 risk

The CLARITY Study is being run by the IBD research team at the Royal Devon and Exeter NHS Foundation Trust and the University of Exeter Medical School, supported by the NIHR Clinical Research Network in the South West.

The study aims to look at the development of antibodies to SARS-CoV-2 (the virus that causes COVID-19) in UK patients with IBD – the umbrella term for Crohn’s Disease and Ulcerative Colitis. Researchers will test samples from approximately 15,000 patients collected since the start of 2020 for antibodies against SARS-CoV-2. At the same time the researchers will follow almost 7,000 patients who are receiving infliximab or vedolizumab, testing for antibodies against the virus every 8 weeks. A positive test suggests a patient has been infected with SARS-CoV-2 in the past use of common IBD drugs, including biologic medicines and immunomodulators meant that a significant proportion of the 500,000 people across the UK living with Crohn’s or Colitis were categorised during the national lockdown as being at higher risk of serious complications from coronavirus.

Tariq Ahmad, Consultant Gastroenterologist, Royal Devon and Exeter NHS Foundation Trust, and Chief Investigator of the study, said: “Immunosuppressive and biologic drugs are effective at reducing inflammation and improving symptoms for most patients with IBD. However, by dampening down the immune system, these drugs increase the risk of certain serious infections and also prevent some vaccines working well.

“Because COVID-19 is caused by a new virus, we don’t yet know if these drugs increase the risk or severity of infection. As a precaution the UK Government advised many patients treated with these medicines to ‘shield’ themselves during the 12-week lockdown, meaning they were advised to not leave their homes, and avoid all contact with others. Although these measures reduced transmission of the virus, they caused isolation and anxiety for many patients, disrupted medical and social care, threatened education and employment, and for society had a significant economic impact.”

The outcomes of patients in the study will be looked at over the next 12 months. Not only will this give new insights into which people with Crohn’s or Colitis are at risk of COVID-19 infection, but also the possible impact of certain IBD medications on developing antibodies against the virus. These learnings could impact the millions of people across the UK who live with other immune mediated diseases, like arthritis, treated with similar therapies.

Inflammatory Bowel Disease (IBD) affects over 500,000 people across the UK. The main symptoms include urgent and frequent bloody diarrhoea, weight loss, severe pain, and extreme fatigue. It is commonly treated with immunosuppressive drugs. This study will investigate the impact of two biologic medicines, infliximab and vedolizumab on COVID-19 infection. It will recruit both children and adults at UK hospitals, also taking into account the impact of shielding from the virus. The results of this study will help inform public health policy decisions for people living with Crohn’s and Colitis, as well as millions of other UK patients treated with immunosuppressive drugs.

Tariq Ahmad said: “This study will help inform public health policy, by determining whether certain immunosuppressive drug regimens and shielding impact SARS-CoV-2 infection risk and the magnitude and durability of protective antibody responses. Although our study will involve patients with IBD there are potentially important lessons to be learned for patients across the UK with other diseases treated with similar therapies.

“With the unprecedented support of the National Institute for Health Research (NIHR) this study will run across an established UK network of hospitals. We will collect information directly from patients about symptoms, tests, hospitalisations and physical distancing behaviour related to COVID-19 and link this to other data already held by other health organisations. Using an antibody test, provided as part of a collaboration with Roche Diagnostics International Limited, we will follow antibody responses to the virus over a 40-week period.”

Researchers at participating hospitals will be approaching volunteers over the next three months, and Crohn’s & Colitis UK will be recruiting the Patient Advisory Group to make sure the voices of people living with Crohn’s and Colitis are at the centre of the study. Participants will be asked to complete a questionnaire every eight weeks and donate a blood sample at infusion visits. The study will use a COVID-19 antibody test to look for past infection in blood and results of the test will be made available to participants. The study will run for 40 weeks by which time it is hoped that enough data will be collected to shed valuable insights into the impact of the two IBD drugs and shielding on COVID-19 infection.

Tony Berry, Chairman of the local IBD Group, member of the Study Management Group and Patient Participation Involvement and Engagement Group, said: “The CLARITY research study is a very important to those of us who are on immunosuppressant and biologic drugs because, at present, there is very little known about the possible increased risk to Crohn’s and Colitis patients on these treatments if they were to contract COVID-19. Patients are also concerned about the increased risk of catching COVID-19, the possible increase in risk of life-threating complications if they became infected with COVID-19 and if future vaccines will be as effective if an IBD patient is on immunosuppressant treatments. Hopefully, the CLARITY study will help answer some of the IBD patients’ concerns and help inform policy decisions in the future.”

Ruth Wakeman, Director of Services, Policy and Evidence at Crohn’s & Colitis UK, said: “Crohn’s & Colitis UK’s recent Life in Lockdown survey found that over half of people are concerned about leaving the house because they are worried about an increased risk of coronavirus complications. The CLARITY study offers the opportunity for a real-world look into risk levels and the impact of medication, not only for people with Crohn’s and Colitis, but for millions of others. In the future, we need to avoid people with Crohn’s and Colitis from being unnecessarily confused, put at risk and anxious – and research such as this is vital to provide much needed answers to support with this.

“Current specialist advice remains that if you are on a medicine that impacts your immune system, you are considered to be at increased risk from coronavirus and should take precautions when leaving the home.”

If you are interested in being involved or want some more information on this study queries can be sent to rde-tr.clarityibd@nhs.net
Visit the study website www.clarityibd.org or Twitter account @CLARITYIBD for more updates.