Sheffield joins national PRINCIPLE trial to prevent older coronavirus patients becoming seriously ill

  • A new national trial, PRINCIPLE, will evaluate if potential treatments for coronavirus are particularly effective for people over 50 years old when prescribed during the early stages of the illness
  • The risk of complications from coronavirus for those over 50 is greater, especially those who have underlying health conditions
  • For this group of people the new viral infection can lead to a greater chance of  significant medical problems, hospitalisation and sometimes death
  • There are no known cures for coronavirus, so the trial aims to see if drugs already available, like hydroxychloroquine, can help prevent older people becoming more seriously ill and prevent the need for hospitalisation

Sheffield has enrolled its first participant in a new national trial to assess whether clinically available drugs identified as potential treatments for coronavirus can help in reducing the risks of older people becoming seriously unwell and prevent the need for hospitalisation.

Led by the University of Oxford, the PRINCIPLE platform trial is recruiting participants from primary care including from a cluster of eight GP surgeries in the area who are members of the Sheffield Primary Care Research (SPCR). These GP surgeries are active clinical researchers who collaborate to identify patients who are able to take part in clinical research studies.

The SPCR is led by Dr Jon Dickson, a Senior Clinical Lecturer from the University of Sheffield’s Academic Unit of Primary Medical Care and GP at Ecclesfield Group Practice.

Dr Dickson said: “We know that people over the age of 50 with coronavirus, especially those with pre-existing conditions, are at higher risk of more serious outcomes. They are more likely to become seriously unwell, need hospitalisation and unfortunately have higher rates of fatality.

“The trial will prescribe clinically available drugs that have been identified as potential treatments to patients suspected of having coronavirus who are at an early stage of the illness, and assess how effective they are at reducing the number of hospitalisations and deaths within this high-risk group.”

Funded by the National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI), the PRINCIPLE platform trial is one of three national priority platform trials in the UK and will begin by assessing the efficacy of a drug called hydroxychloroquine. Hydroxychloroquine is a well known drug used for conditions such as malaria and arthritis, but is not currently used to treat this kind of infection.

One group of participants will be given the drug treatment, and a second group will be treated using the current best available NHS guidance for at-home recovery.

Dr Dickson’s research at the University focuses on health-service quality improvement interventions and delivery of research in primary care. He hopes the trial will provide new treatments that can be made available quickly to GPs to help them reduce the risk of older patients becoming seriously unwell with coronavirus.

He added: “There is some evidence that hydroxychloroquine may be effective in reducing the severity of the effects of coronavirus. If we can prove the efficacy of using hydroxychloroquine, it will help us improve outcomes for high-risk groups and save lives.”

Sheffield SCPR hopes to recruit up to 100 participants to the trial, the scope of which can expand rapidly and flexibly to include testing for other potential treatments that could also be identified as being of benefit to coronavirus patients. The trial is planning to recruit up to 3,000 patients nationally.

“For the most part, coronavirus is a mild self-limiting illness, which most people can recover from following the best advice and guidance to stay well from the NHS at home,” said Dr Dickson.

“However, as intensive care units in hospitals are at risk of being overwhelmed with the higher numbers of seriously ill patients than usual being admitted during the pandemic. Anything we can do to reduce the likelihood that those patients will need hospitalisation in the first place will have a positive effect for the NHS and have an impact in reducing the current death rates of the viral infection in those high-risk groups.

Eligible patients will be asked if they would like to join the trial at participating GP Surgeries in Sheffield, to find out which have enrolled, you can read more on the University of Oxford website.