Paxlovid (nirmatrelvir + ritonavir; Pfizer) has become the second COVID-19 antiviral to be added to the ‘Platform Adaptive trial of novel antivirals for early treatment of COVID-19 In the community’ (PANORAMIC), the government has announced.
In a statement published on 12 April 2022, the Department of Health and Social Care (DHSC) said that more than 20,000 patients have joined the study in just over three months and the addition of Paxlovid will allow a further 17,500 patients to enrol.
Paxlovid, which was first approved for use in the UK in December 2021, was found to reduce the relative risk of death or hospitalisation in COVID-19 patients by 88% in clinical trials by inhibiting a protease required for viral replication.
It is currently recommended as first line for the treatment of non-hospitalised COVID-19 patients and hospitalised patients who test positive for COVID-19 following their admission to hospital, provided they meet certain criteria that puts them at higher risk of serious illness (see Box).
The PANORAMIC trial, which is run by the University of Oxford and funded by the National Institute for Health Research, had previously only been investigating the oral antiviral molnupiravir to see if it helps clinically vulnerable people diagnosed with COVID-19 recover sooner and prevent them having to attend hospital.
To be eligible for enrolment onto the trial, participants must be aged 50 years and over, or aged 18–49 years with underlying health conditions, such as chronic heart or kidney disease, that make them clinically more vulnerable.
All participants need to have recorded a positive PCR test within the past seven days and to have felt unwell with COVID-19 symptoms within the past five days.
Pharmacies, GP surgeries and other healthcare settings are helping to identify suitable participants and inviting them to take part. Potential recruits can also self-register through the PANORAMIC website.
Once registered on the trial, participants will be treated in the community and offered either an antiviral treatment in addition to standard NHS care or receive standard NHS care alone.
According to the trial protocol, ‘standard NHS care’ “will not be specified or mandated, and it will vary over time according to emerging evidence and evolving national recommendations and will be tailored by responsible clinicians to patient characteristics, clinical picture, and individual need”.
The aim of PANORAMIC is to ensure that antivirals are being used in the most effective way and that clinicians have the full information to prescribe antiviral treatments to patients in future.
Sajid Javid, health and social care secretary, said in a statement published on 12 April 2022: “As we learn to live with COVID-19, the UK continues to lead the way in using cutting-edge treatments which have already saved the lives of many of the country’s most vulnerable patients.
“The addition of Paxlovid to the ground-breaking PANORAMIC study is an important milestone and will help us understand who benefits most from these treatments.”
The expansion of PANORAMIC comes after NHS England announced on 9 April 2022 that more than 32,000 at-risk patients have received a COVID-19 antiviral since they were made available to patients outside of hospital in December 2021.
Chris Butler, professor of primary care at the University of Oxford and clinical lead of the PANORAMIC trial, said these antiviral treatments could “have their greatest benefit” to patients soon after they contract COVID-19, when they are still being cared for in the community.
“The PANORAMIC trial is testing whether novel, promising antiviral treatments help people suffering from COVID-19 in the community to recover faster and reduce the need for treatment in hospital,” he added.
“It is critically important that new treatments are tested on people and in the situation where they are intended to be used. Joining the PANORAMIC trial will help ensure people with COVID-19, and indeed the NHS, get the maximum benefit from these precious treatments.”
While the study is UK-wide, recruitment to the Paxlovid arm will initially only be available in England.
The DHSC said it was working with counterparts in the devolved governments to develop plans for how this arm could be started in all four nations “in due course”.
Box: Patient cohorts to be prioritised for treatment with neutralising monoclonal antibodies and oral antivirals
- All patients with Down’s syndrome;
- Some patients with a solid cancer, such as active metastatic cancer, or active solid cancers at any stage;
- Some patients with a haematological disease and stem cell transplant recipients (e.g. all patients with sickle cell disease);
- Some patients with renal disease (e.g. renal transplant recipients);
- Some patients with liver disease (e.g. those on immune suppressive therapy);
- Some patients with immune-mediated inflammatory disorders (those who have received treatment with rituximab or another B cell depleting therapy in the past 12 months);
- Some patients with primary immune deficiencies (e.g. severe combined immunodeficiency);
- Some patients with HIV/AIDS (e.g. those with high levels of immune suppression);
- All solid organ transplant recipients;
- Some patients with rare neurological conditions, such as multiple sclerosis.