Thousands of the UK's most vulnerable people will be among the first in the world to access life-saving, cutting-edge antiviral and antibody treatments from today, the government has announced.
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.
Those at highest risk 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.
This will ensure the treatments can help protect those most at risk from the virus over the winter months, reducing the number of hospitalizations 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.
Molnupiravir has shown in clinical trials to reduce the risk of hospitalization or death for at-risk, non-hospitalized adults with mild to moderate COVID-19 by 30% and Ronapreve reduced the risk by 70%.
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."
National study for molnupiravir
The study, which is currently for molnupiravir, has been launched today to 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.
It's 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 enroll 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.
Targeted deployment of molnupiravir and Ronapreve
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. The eligible cohorts have been determined by an independent expert group commissioned by DHSC and included in a clinical policy agreed by all four Chief Medical Officers in the UK.
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.
Those being prescribed a monoclonal antibody treatment will be invited to attend the CMDU, while those receiving molnupiravir can either get someone to collect it for them or have it delivered to their home. The NHS has been setting up CMDUs since the summer.
The government has secured 480,000 courses of molnupiravir from pharmaceutical company Merck Sharp and Dohme (MSD). It has also secured 250,000 courses of the antiviral PF-07321332, which is currently has completed phase 3 trials.
Chair of the Antivirals Taskforce Eddie Gray said:
This is an important advancement for the treatment of COVID-19 in the UK and marks a significant step in the Antivirals Taskforce's ambition to roll out two novel antivirals to patients.
Work is still underway to identify further options as soon as we can - to protect as many vulnerable people across the country as possible."
Antivirals are treatments used to either treat those who are infected with a virus or protect exposed individuals from becoming infected. They target the virus at an early stage, preventing progression to more severe, or even critical, symptoms.
The Antivirals Taskforce will continue to look at a number of further options, spanning a range of different antiviral mechanisms. Alongside the work of the Therapeutics Taskforce, this will ensure as many people as possible can be protected from COVID-19, future variants and other future diseases.
Since the beginning of the pandemic, the UK has proven itself to be a world-leader in identifying and rolling out effective treatments for COVID-19 - including the world's first treatment dexamethasone, which has since saved over a million lives worldwide.
The UK's renowned life sciences sector makes it the ideal base for the brightest of global innovators to research and progress cutting-edge treatments for COVID-19 through the clinical trials process here in Britain.
Professor Chris Butler, Professor of Primary Care at the University of Oxford's Nuffield Department of Primary Care Health Sciences and Co-Chief Investigator of PANORAMIC, said:
Studies in relatively small numbers of people with COVID-19 who have not yet been vaccinated have generated optimism that these new antiviral medicines, if used at scale, could reduce the need for people to be admitted to hospital and help them recover faster.
The PANORAMIC trial is a world-first study for generating the evidence we urgently need about large scale, early treatment with novel antiviral medicines of people who are mostly all vaccinated, still well enough to be in the community, and who are at higher risk of complications from COVID-19."
Professor Stephen Powis, NHS England's National Medical Director, said:
The rollout of monoclonal antibodies and antivirals represents another weapon in our arsenal to reduce the risk of patients at highest risk becoming seriously ill and needing hospitalization from COVID-19.
It represents another achievement for the NHS following our world leading vaccination programme that has now delivered 100 million vaccinations in England, including over 17 million booster vaccines.
Getting vaccinated is the best way to protect you and your loved ones from COVID-19 and I would urge everyone to come forward to get vaccinated - whether that's your first, second or booster jab."
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