Ground-breaking COVID-19 antiviral treatment trial opens to recruitment in the east of England
Local GPs
and healthcare professionals have today (9 Dec 2021) begun enrolling participants across the
east of England to a first-of-its-kind clinical trial investigating the
effectiveness of new oral antiviral treatments for COVID-19 - which can be
safely taken at home.
The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of covid-19 In the Community (PANORAMIC) trial will rapidly assess a range of purpose-designed antiviral treatments which could help clinically vulnerable people with COVID-19 in the community recover sooner, prevent the need for hospital admission and ease the burden on the NHS.
These new antiviral treatments are intended for use in the very early stages of infection, by people in the community with COVID-19 who are at higher risk of complications.
Local
people can join the study if they are aged 50 and over, or between 18 to 49
years with underlying health conditions that make them clinically more
vulnerable. All participants also need to have had a positive COVID-19 test and
be within five days of the onset of symptoms.
To enable the benefit of each treatment to be compared against standard care - a total of 10,600 volunteers are needed to take part in each arm of the study. Half of the participants will be randomly allocated to receive the antiviral treatment plus standard care, while the other half will receive standard care alone.
The
PANORAMIC study brings together GP practices, NHS 111, Test and Trace, care
homes, pharmacies and other NHS and social care service providers from the east
of England and right across the UK - who will actively identify potential
participants, invite them to take part and support their participation.
Taking
part is easy. Local people who receive a positive PCR test for COVID-19 will be
contacted by the trial team or a local healthcare professional, such as a GP or
a research nurse, to consider enrolling in the study. Alternatively, anyone who
meets the eligibility criteria can also sign-up to take part in the study
directly through the trial website: www.panoramictrial.org
All
participants take part from their own homes, without needing to visit a clinic
or hospital. Participants randomised to the group that receives an antiviral
treatment will have their medicines sent directly to their homes by courier.
Participants will keep 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 and any NHS care they have needed.
PANORAMIC has been designed as a ‘platform clinical trial’, meaning it can rapidly evaluate several antiviral treatments, as and when they become available. The UK Antivirals Taskforce has selected all treatments to be tested. The first treatment to be investigated through the trial will be molnupiravir (brand name, Lagevrio) - a COVID antiviral pill - which has already been licensed by the MHRA.
The results from this highest priority national study will provide a clearer understanding on how antivirals work in the UK population - which has a high vaccination rate - enabling the NHS to better plan how to make COVID-19 antivirals available for those who would benefit from them the most.
Dr Serge Engamba, Principal Investigator for the PANORAMIC trial at the Norfolk and Waveney NHS Clinical Commissioning Group (CCG) and Primary Care Lead for the NIHR’s Clinical Research Network Eastern, said:
“The PANORAMIC trial
is essential in finding new treatments which can combat the virus directly,
giving those most vulnerable an additional chance to avoid hospital admissions
and life-threatening symptoms. Its innovative approach may mean that new
life-saving treatments are quickly identified and can be made available in the
community. OneNorwich Practices Research Hub is very pleased to have been
selected as one of the sites to carry out
this ground-breaking endeavour, and we hope as many people can
benefit from it as possible.”
Dr Rhiannon Nally, Principal Investigator for PANORAMIC and GP at Wansford and Kings Cliffe Practice, Ely, Cambs, said:
"The Research Team at Wansford is
delighted to have been selected to host the Panoramic Study, helping people in
our local community to take part in this vital research. It is only with their
involvement that we can find new, more effective ways to help those with
COVID-19, so if you have had symptoms for less than 5 days please do think
about joining the PANORAMIC trial."
Dr Helen Macdonald, Chief Operating Officer for the NIHR Clinical Research Network Eastern, said:
"Our region welcomes the opening of this crucial study, particularly at a time when we face a further need for vigilance in the course of the pandemic. We will work side by side with our GPs and other NHS research teams to help run this important COVID-19 study. It is only through working together that we will make the breakthroughs we need, so thank you to all who join us."
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Professor Nick Lemoine, Medical Director of the National Institute for Health Research Clinical Research Network (CRN) said:
“When taken in the earliest stages of infection, these ground-breaking, purpose-designed, COVID-19 antiviral treatments hold the potential to greatly improve outcomes for patients most at risk from the disease. As orally-administered treatments, designed to be taken at home soon after the onset of symptoms, the drugs work by disrupting and preventing the virus from multiplying inside the body.
“Earlier trials have shown these new antivirals to be safe and effective in treating COVID-19. However more data is needed on how well they work in populations that are largely vaccinated - as we have in the UK. The PANORAMIC trial will rapidly generate the additional evidence needed for the NHS to roll-out this exciting new-generation of COVID-19 treatments, as quickly and safely as possible. But to do that, we need your help.
“If you have a PCR-confirmed COVID-19 test, are within 5 days of symptom onset - and meet the study eligibility criteria - we urge you to volunteer for this pivotal study. Participants take part from the comfort of their own homes and there is no need to visit a clinic or hospital. Visit the PANORAMIC website to sign up, or speak to your GP or healthcare professional about taking part.”
The trial’s Chief Investigator, Professor Chris Butler, Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences, said:
“It is early on in the illness, when people are still being cared for in the community, that treatments for COVID-19 could have their greatest benefit. So far, a lot of the research has focussed on finding out if well-known drugs can be repurposed to treat COVID-19. This new trial will test whether exciting, new antiviral treatments that are more specific to COVID-19 help people in the community recover faster and reduce the need for treatment in hospital.
“All
community health and social care providers in the East of England will be able
to link people with the trial. Everyone who is eligible in the area and the UK
as a whole will be able to join PANORAMIC, and many will be able to do so from
their own homes by participating online with support from their GPs and study
team, with medicines sent directly to them at home.
“It’s vital
that as many people as possible who are at higher risk from complications of
COVID-19 join the trial so we can rapidly learn if exciting new treatments
really do help people get better quicker and reduce pressures on the NHS. We
are grateful to people in the East of England who are participating in the
trial, as they will be helping health services rapidly get evidence-based
treatments out to those sick with COVID and who are at greatest risk of
complications.”
The NIHR is partnering with the University of Oxford, several other UK universities, GPs and the NHS to help deliver this national priority trial at pace and scale across the United Kingdom.
PANORAMIC
is funded by the National Institute for Health Research, led by Oxford
University’s Primary Care Clinical Trials Unit, while
delivery of the trial is supported by the NIHR Clinical Research Network.
For further information, please visit: www.panoramictrial.org