The recently-approved oral antiviral molnupiravir will be the first to be investigated in a UK-wide trial of new treatments for COVID-19 in patients at higher risk of complications from the disease.
The Platform Adaptive trial of Novel Antivirals for Early Treatment of COVID-19 In the Community (PANORAMIC) aims to rapidly evaluate several antiviral treatments that could help clinically vulnerable people diagnosed with COVID-19 recover sooner and prevent them having to attend hospital.
It will see GP practices, pharmacies and other health and social care services invite people to take part. As part of the trial, participants will receive current standard care, with or without the new antiviral treatment.
According to a press release issued by Nuffield Department of Primary Care Health Sciences at the University of Oxford on 8 December 2021, the UK Antivirals Taskforce has selected all treatments to be tested, but molnupiravir is the only treatment to be announced so far.
Eligible participants for the study include those aged 50 years and over, and those aged 18–49 years with underlying health conditions that make them clinically more vulnerable who have been unwell with COVID-19 for less than five days. All participants will need to have recorded a positive PCR test within the past seven days.
Around 10,600 volunteers are needed in total to take part in the trial, with 5,300 people to be recruited to receive molnupiravir plus standard care, with the remaining 5,300 to receive standard care only.
“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,” explained Chris Butler, professor of primary care in the Nuffield Department of Primary Care Health Sciences and chief investigator of the trial.
“So far, a lot of the research has focused 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.”
Mahendra Patel, pharmacy and inclusion and diversity lead for PANORAMIC, said that those running the trial would be “working closely” with pharmacists and their teams across settings to help play a crucial role in raising UK-wide awareness of the trial and in supporting greater recruitment of volunteers from disadvantaged and diverse backgrounds.
The trial will also assess the effectiveness of the treatments on reducing shedding of the virus, as well as on preventing the spread of COVID-19 by offering treatment to some household contacts of participants.
On 20 October 2021, the government announced that it had purchased 480,000 doses of molnupiravir, which later became the first oral antiviral to be approved by the Medicines and Healthcare products Regulatory Agency for the treatment of COVID-19 in people who have mild-to-moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age (>60 years), diabetes mellitus or heart disease.
However, an update on a study investigating the efficacy of molnupiravir has suggested the oral antiviral drug is not as effective at preventing hospitalisations and deaths owing to COVID-19 as originally estimated.
The study, which has not been peer reviewed, suggested that molnupiravir reduced the risk of hospitalisation or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group.
This was equivalent to an absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1, 5.9; nominal P=0.02) and a relative risk reduction of 30% (relative risk 0.70; 95% CI: 0.49, 0.99).
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- This news story was amended on 9 December 2021 to clarify that eligible participants include those aged 18–49 years with underlying health conditions that make them clinically more vulnerable who have also been unwell with COVID-19 for less than five days