University of Oxford antiviral trial launched
A clinical trial to investigate the effectiveness of new COVID-19 oral antiviral treatments has begun enrolling participants.
The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community (PANORAMIC) is being led by the University of Oxford with support from the NIHR Clinical Research Network Thames Valley and South Midlands.
The trial will rapidly assess the effectiveness of a range of novel, purpose-designed COVID-19 antivirals. These new orally administered 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 from the disease.
People can join the study if they have a positive COVID-19 test, are within five days from the onset of symptoms and are aged 50 and over or aged 18 to 49 with underlying health conditions that make them clinically more vulnerable. All participants should have recorded a positive PCR test within the past seven days.
The researchers will enrol 10,600 volunteers for each arm of the study. To enable the benefit of the treatment to be compared against standard care, half the participants will be randomly allocated to receive the antiviral treatment plus standard care while the other half will receive standard care alone.
The results from the 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.
PANORAMIC will bring together GP practices, NHS 111, Test and Trace, care homes, pharmacies and other NHS and social care service providers UK-wide who will actively identify potential participants, invite them to take part and support their participation.
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 tests positive for COVID-19 and 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. For participants randomised to the group that receives an antiviral treatment, medicines will be sent to people’s homes from an online pharmacy 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 seven, 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 that could help clinically vulnerable people with COVID-19 recover sooner, prevent the need for hospital admission and so ease the burden on the NHS. The UK Antivirals Taskforce has selected all treatments to be tested.
The first new treatment to be investigated will be molnupiravir (brand name, Lagevrio), a COVID antiviral pill which has already been licensed by the MHRA. Additional new antiviral treatments will also be investigated through different arms of the trial platform, as and when they become available.
Trial Chief Investigator, Professor Chris Butler, Professor of Primary Care at the university’s 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.
“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. The health services will then be able to rapidly get evidence-based treatments out to those sick with COVID and who are at greatest risk of complications.”
For further information visit: www.panoramictrial.org
