(HealthDay News) — Adding molnupiravir to usual care does not reduce the frequency of COVID-19-associated hospitalizations or deaths at 28 days for high-risk, vaccinated adults, according to a study published in The Lancet.
Researchers conducted a randomized trial involving participants aged 50 years or older, or aged 18 years or older with relevant comorbidities, who had confirmed COVID-19 for 5 days or fewer. Participants were randomly assigned to receive usual care alone or usual care plus molnupiravir at 800 mg twice daily for 5 days.
The primary analysis included 12,529 patients from the group receiving molnupiravir and 12,525 patients from the group receiving usual care alone. In the overall cohort, 94% of patients had received at least 3 doses of a COVID-19 vaccine.
The primary outcome was all-cause hospitalization or death within 28 days of randomization. The researchers assessed patient outcomes via a patient-completed online daily diary.
In both treatment groups, hospitalization or death was recorded for 1% of patients (adjusted odds ratio, 1.06). Adverse events were recorded for 0.4% of patients in the molnupiravir group and 0.3% of patients in the usual care group.
“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 study authors wrote.
Several authors disclosed financial ties to biopharmaceutical companies, including Merck, the manufacturer of molnupiravir.