(HealthDay News) — For high-risk vaccinated adults, molnupiravir plus usual care does not reduce the frequency of COVID-19-associated hospitalizations or deaths, according to a study published online Dec. 22 in The Lancet.
Christopher C. Butler, M.D., from the University of Oxford in the United Kingdom, and colleagues conducted a prospective, randomized controlled trial involving participants aged 50 years or older, or aged 18 years or older with relevant comorbidities, with confirmed COVID-19 for five days or fewer in the community. Participants were randomly assigned to 800 mg molnupiravir twice daily for five days plus usual care or usual care alone (12,821 and 12,962 participants, respectively).
The primary analysis population included 12,529 participants from the group receiving molnupiravir plus usual care and 12,525 from the group receiving usual care alone. Overall, 94 percent of the population had received at least three doses of the COVID-19 vaccine. The researchers found that 1 percent of participants in both the group receiving molnupiravir plus usual care and the group receiving usual care alone had hospitalizations or deaths recorded (adjusted odds ratio, 1.06; 95 percent Bayesian credible interval, 0.81 to 1.41; probability of superiority, 0.33). No evidence of treatment interaction was seen between subgroups. Adverse events occurred in 0.4 and 0.3 percent of those in the group receiving molnupiravir plus usual care and the group receiving usual care alone, respectively, with none related to molnupiravir.
“Further virological and health economic analyses are underway, and participants are still being followed up to establish the effect of acute COVID-19 treatment with molnupiravir on longer-term symptoms,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Merck, the manufacturer of molnupiravir.