People with epilepsy included in new Covid-19 treatment study
Thousands of the UK’s most vulnerable people – including those with epilepsy - will be among the first in the world to to take part in a home study looking at potentially life-saving antiviral and antibody treatments if they test positive for Covid-19.
A national study ‘PANORAMIC’, run by the University of Oxford in close collaboration with GP hubs, has now launched and is recruiting around 10,000 UK patients at risk of serious illness from COVID-19 to have the opportunity to take the treatment molnupiravir at home after receiving a positive PCR test.
Participants in the study will be randomly selected to either be in a group that receives a course of oral antiviral treatments plus standard of care, or a group that receives the current standard of care only.
Two different groups are needed so the study team can see any difference in the health of those who received the antiviral treatment compared to those who didn’t. All participants will be able to access any NHS care that they would normally expect to receive.
Molnupiravir has shown in clinical trials to reduce the risk of hospitalisation or death for at-risk, non-hospitalised adults with mild to moderate COVID-19 by 30 per cent.
The study will allow medical experts to gather further data on the potential benefits this treatment brings to vaccinated patients, and will help the NHS to develop plans for rolling out the antiviral to further patients next year.
Eligibility for the study
The study is open to anyone in the UK, provided they:
- receive a positive PCR test
- feel unwell with symptoms of COVID-19 that started in the last five days
- and are aged 50 and over or 18 to 49 with an underlying health condition that puts them more at risk of severe COVID-19.
If eligible, people who receive a positive PCR test will be contacted by the study team or a local healthcare professional, for example their GP, to sign up to the trial. Alternatively, people can sign up themselves through the study’s website.
It is crucial that eligible participants enrol in the study urgently to ensure that they have the opportunity to access antiviral treatments within the first five days of COVID-19 symptoms.
Taking part in the study will require participants to complete a daily diary for 28 days through the PANORAMIC website or receive a phone call from the trial team on days 7, 14 and 28 to speak about their symptoms. The first set of results from the trial are anticipated in early 2022.
Treatment for highest risk group
Those at highest risk from Covid who test positive for the virus - for example, people who are immunocompromised, cancer patients or those with Down’s syndrome - will also be able to access either molnupiravir or the novel monoclonal antibody ronapreve outside of the study from 16 December.
Ronapreve has shown in clinical trials to reduce the risk of hospitalisation or death for at-risk, non-hospitalised adults with mild to moderate COVID-19 by 70%.
This will ensure the treatments can help protect those most at risk from the virus over the winter months, reducing the number of hospitalisations and therefore pressures on the NHS. This will be significant for those who have compromised immune systems and for whom the vaccines can therefore be less effective.
People with epilepsy are not included in this group.
For treatment access outside of the study, those in the highest risk group will be informed by the NHS if they have a condition that will make them eligible to receive these treatments, should they test positive for COVID-19.
These patients will be able to keep a PCR test at home from NHS Test and Trace to support rapid testing, so they can access the treatments as soon as possible after symptoms begin.
Eligible patients who receive a positive test will be assessed over the phone by an expert clinician from an NHS COVID Medicines Delivery Unit (CMDU), who will review and discuss with the patient what the most appropriate treatment would be for them.
Health and Social Care Secretary Sajid Javid said:
“The UK is a world-leader in rolling out innovative treatments to the patients who need them and today is a historic milestone in our battle against the virus, deploying the first medicines vulnerable people will be able to take outside of hospital and in the comfort of their own homes to protect themselves.
“This opens up a new era for the treatment of COVID-19, one where we can begin to cover every phase of contracting this deadly disease – whether it be before you catch it, just after you catch it, if you develop symptoms or if you require hospital care.
“If you’re eligible, please sign up to the study as soon as possible and play your part in history.”
Deputy Chief Medical Officer for England Professor Jonathan Van-Tam said:
“Throughout this pandemic, we have rapidly identified and deployed some of the world’s best treatments for COVID-19 to UK patients - including dexamethasone, tocilizumab and sarilumab.
“Antivirals will be a vital intervention for years to come, helping to protect those that can’t mount the same antibody response to the vaccines.
“This is really positive news for the future of our response to COVID-19 - please sign up to the study if you’re eligible as soon as you can.”