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The AGILE consortium- directed by the University of Liverpool, recently released a report on the antiviral drug molnupiravir for treating people with COVID.

Molnupiravir obtained regulatory acceptance for treating people with gentle to moderate COVID-19 who are at inflated risk of developing a severe illness in November 2021. These approvals were based exclusively on data from unvaccinated people, which revealed the drug was effective and lowered the risk of death and hospital admissions in those at the most increased risk of severe COVID-19. Determining the significance of molnupiravir in highly immunized populations is key to its continued use.

The recent results from the AGILE platform, publicised in The Lancet Infectious Diseases, report evidence of antiviral activity with molnupiravir in a population of vaccinated & unvaccinated participants contaminated with a wide range of SARS-COV-2 viral variants.

Chief Investigator for AGILE, Professor Saye Khoo, said in a continuously changing pandemic, it is crucial to understand if drugs remain persuasive in today’s population with the circulating variants we encounter.

Saye Khoo added that we monitored an antiviral effect in vaccinated and unvaccinated people infected/contaminated with variants including Delta and Omicron. What we do not yet know is how much of this antiviral advantage translates into a clinical benefit – since the threat of severe COVID-19 depends on aspects such as the immune system, host characteristics, and concomitant diseases.

The AGILE team undertook a Phase I trial of molnupiravir, considering a range of dosing to specify the optimal dose of molnupiravir for treating COVID-19 illness. These data were shared with the manufacturer Merck who later undertook their pivotal late-phase licensing practice in unvaccinated patients. Meanwhile, AGILE continued with this phase II trial in the broader population of vaccinated and unvaccinated patients, registering across the NIHR Clinical Research Facilities in Liverpool, Manchester, Southampton, London, and Lancashire.

Samples accumulated from participants in the AGILE trial are now being studied in the laboratory to achieve a better understanding of which patients and COVID-19 variants molnupiravir can be most effective for and in the expectancy, it is an appropriate drug for everyone in the community to access as soon as they are found to have COVID-19.

AGILE is a consortium containing NIHR Clinical Research Facilities across the UK, the Liverpool School of Tropical Medicine, the NIHR Southampton Clinical Trials Unit, and other partners led by the University of Liverpool.