A national study called ‘PANORAMIC’ - run by the University of Oxford with GP hubs - will see GP practices and other healthcare providers recruit up to 10,600 patients aged over 50, or aged 18 to 49 and at risk of serious illness from COVID-19 to take the treatment molnupiravir at home after receiving a positive PCR test.
The study, which launches today, will see GPs identify potential participants, invite them to take part and support their participation. Participants who test positive for coronavirus and start treatment will be asked to complete a daily diary for 28 days, or have weekly calls to discuss their symptoms.
Experts hope to gather further data on the potential benefits of the treatments for vaccinated patients, to inform rollout plans for the antiviral next year. Results of the trial are anticipated in early 2022.
Patients at the highest risk, including the immunocompromised, people with cancer, people with Down’s syndrome, or those who test positive for coronavirus will be able to access either molnupiravir or the novel monoclonal antibody Ronapreve outside of the study from 16 December.
GPonline reported in November that GPs could be able to prescribe molnupiravir to treat COVID-19 after it was approved by the UK medicines regulator - with trials showing it reduced infected patients' risk of hospitalisation or death.
PANORAMIC has been designed as a ‘platform clinical trial’, meaning it can rapidly evaluate several antiviral treatments over time 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.
Those contacted by the study are urged to enroll urgently to ensure that they have the opportunity to access antiviral treatments within the first five days of COVID-19 symptoms following PCR test, when the drug is most effective.
Professor Chris Butler, co-chief investigator of PANORAMIC and professor of primary care at the University of Oxford’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.
‘All community health and social care providers will be able to link people with the trial; everyone who is eligible across the UK 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.’
People receiving the treatments outside of the trial 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.
High risk groups
Those being prescribed a monoclonal antibody treatment will be invited to attend the CMDU, while those receiving molnupiravir can have someone collect it for them or have it delivered to their home.
Patients who feel they may be eligible for the treatment but have not been contacted are invited to contact their GP or consultant to discuss whether they should be in the highest risk group. They will be provided with further information on next steps if appropriate.
The MHRA approved the second COVID-19 treatment sotrovimab last week, after trials found it reduced risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection.
The treatment molnupiravir can be taken orally in pill form and is effective at reducing risk of hospitalisation and death in people with mild to moderate infection with the virus who are at high risk of developing severe disease.