‘Trial group diversity is key to vaccine efficacy’

By Professor Mahendra G Patel

AS WE enter a new period of restrictions follow­ing a rise in Covid-19 cases; and with the onset of winter just around the corner and no clear idea of when a vaccine might be available, it has never been more important to take what measures we can to limit the spread of this deadly virus.

This is especially true among people from black, Asian, minority and ethnic (BAME) backgrounds, who have been shown to be more at risk due to a number of factors, such as inter-generational liv­ing, longstanding religious beliefs, health inequali­ties, housing conditions, public-facing occupa­tions, structural racism and even language barriers.

Vaccine trials will continue apace, but such is the danger posed by transmission of Covid-19, a risk increased by the return of students to schools and universities and the partial re-opening of the econ­omy, that we need to explore all avenues to fight this disease.

One such approach is the PRINCIPLE trial, led by the University of Oxford Primary Care Trials Unit investigating treatment options for Covid-19. This is a government-backed, nationwide clinical trial for the over-50s suitable for treatment at home.

In my national role for the trial as pharmacy re­search lead and co-investigator, I am looking for­ward to working closely with experts at Oxford in the urgent search for a suitable treatment for Cov­id-19. As an academic at the School of Pharmacy and Medical Sciences, University of Bradford, I will be promoting the trial within Bradford and York­shire, but also beyond through academic and health organisations.

Furthermore, as a national pharmacy board member of the Royal Pharmaceutical Society, I will be looking to the support of pharmacists across all settings, as well as working closely with the na­tional and large multiples, small multiples, and in­dependent community pharmacies, and GP prac­tices nationally. Pharmacists can play a cruical role supporting recruitment to these and other trials.

The PRINCIPLE trial is testing whether treat­ment in the community, using two commonly pre­scribed antibiotics – azithromycin and doxycycline – can help people at higher risk of complications from Covid-19 to recover sooner, reducing the need for hospital admission. Both drugs are widely used to treat a range of bacterial infections including pneumonia and other respiratory tract infections.

This is a nationwide trial open to anyone in the UK aged 50-64 with a pre-existing illness, or aged 65 with coronavirus symptoms of continuous cough, high temperature, loss/change of taste and/or smell in past 14 days or with a positive test with any symptoms in past 14 days.

Anyone who is eligible can join the trial online from home; and for the trial to be successful, we need the support of every primary care and urgent care health professional in the UK

PRINCIPLE is a platform trial, so we can remove treatments early if they are proven to be ineffective and add new treatments as they are identified.

The trial is currently evaluating two antibiotics, azithromycin and doxycycline. Participants will be assigned to either usual care, or usual care plus one of the treatments. There is no placebo. The study drugs can be taken at home.

Oxford University and its team of experts recog­nise the importance of engaging the black and Asian communities and those from low socio-ec­nomic background who have been most affected. Indeed, as a senior academic and pharmacist with many years of experience in promoting health edu­cation within such communities and engaging in vital peices of research around health and health inequalities, this is very welcome news.

Socio-economic disadvantage is not limited to those from BAME communities. There will be other social groups, particularly those from deprived backgrounds, who are also disproportionately af­fected. This virus knows nothing of our politics, it does not see the colour of our skin, but it does ex­ploit vulnerability. It is already well established that those from BAME backgrounds have a greater chance of developing type 2 diabetes, heart dis­ease, stroke and some forms of cancer, all of which could make easier targets for this infection.

Delivery of the trial and recruitment of partici­pants is supported by the National Institute for Health Research Clinical Research Networks across more than 800 general practices.

Thus far, more than 900 participants have been recuited, and the more the merrier. It is crucial we recruit people from varying and representative backgrounds in order for proper analysis of the da­ta to be meaningful in terms of the effectivess of the treatment in all groups. See www.principletrial.org for more information.

Professor Mahendra G Patel is the national BAME and community pharmacy research lead and co-investigator of the Principle Trial at Nuffield De­partment of Primary Care Health Sciences, Univer­sity of Oxford.