U.K. Studies Oral Antiviral for Hospitalized COVID-19 Patients

Based in the U.K., the world's most extensive clinical study investigating potential COVID-19 treatments announced on January 24, 2022, testing Merck's oral antiviral treatment molnupiravir will begin with about 46,500 participants.

Whilst it has already been approved in the U.K. for treating people in the community with mild COVID-19 who are at high risk of developing the severe disease, for instance, cancer patients, it is unknown whether molnupiravir can also benefit patients who have been hospitalized because of COVID-19.

The study is open to all patients hospitalized with severe COVID-19 and in 177 NHS hospital sites across the U.K.

The RECOVERY Trial was initially launched as emergency response in March 2020 and has discovered three effective treatments for COVID-19: the inexpensive steroid dexamethasone; the arthritis drug tocilizumab; and a monoclonal antibody treatment, now known as Ronapreve (REGEN-COV).

However, as the emergence of the Omicron variant demonstrates, it remains essential to investigate new potential treatments.

Molnupiravir, a tablet treatment initially developed for influenza, causes errors to accumulate in the genetic code of the SARS-CoV-2 coronavirus, preventing the virus from replicating.

The RECOVERY intends to compare molnupiravir (800 mg twice daily for five days) with the usual standard of hospital care in adult patients.

Sir Martin Landray, Professor of Medicine and Epidemiology at Oxford Population Health, University of Oxford, and Joint Chief Investigator for RECOVERY, said in a press statement, "Throughout this pandemic, we have seen the important role that clinical trials play in assessing possible treatments for patients admitted to hospital with COVID-19."

"Because RECOVERY is now an established part of the routine care of NHS patients, the trial is well placed to recruit participants whenever and wherever patients are hospitalized with this disease."

 Molnupiravir is also being investigated as an at-home treatment by the PANORAMIC Trial, led by Oxford University's Nuffield Department of Primary Care Health Sciences.

The RECOVERY Trial continues to investigate other treatments, including sotrovimab, an investigational monoclonal antibody.

Note: The U.S. FDA authorized molnupiravir for certain people in December 2021. Separately, a study published by peer-reviewed The NEJM on December 16, 2021, found early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19.