Ensitrelvir Reduces symptoms in mild to moderate COVID-19: Phase 3 Trial
Despite vaccination efforts, COVID-19 treatment options are still needed, especially for those with mild to moderate symptoms. Ensitrelvir, a novel antiviral medication, was evaluated in a randomized clinical trial to assess its ability to reduce symptom duration and improve patient outcomes. As the COVID-19 pandemic continues, the search for effective treatment options remains paramount.
This study was published in the journal JAMA Network Open by Hiroshi Y and colleagues. A recent phase 3 clinical trial investigated the efficacy and safety of ensitrelvir in patients with mild to moderate COVID-19. The phase 3 trial, part of a larger phase 2/3 study, was conducted across 92 institutions in Japan, Vietnam, and South Korea from February 10 to July 10, 2022. A total of 1821 patients aged 12 to <70 years with mild to moderate COVID-19 were enrolled, randomized, and followed for 28 days.
Patients were randomly assigned to receive either 125 mg or 250 mg of once-daily ensitrelvir or placebo for 5 days. The primary endpoint was the time to resolution of the composite of 5 characteristic symptoms of SARS-CoV-2 Omicron infection.
In patients treated within 72 hours of symptom onset, the 125-mg ensitrelvir group showed a significant reduction in symptom duration compared to placebo (P = .04). The median time to resolution was approximately 1 day shorter in the ensitrelvir group compared to placebo.
Adverse events were observed in 44.2% of patients in the 125-mg ensitrelvir group, 53.6% in the 250-mg ensitrelvir group, and 24.8% in the placebo group. No treatment-related serious adverse events were reported.
The study concluded that ensitrelvir, particularly at the 125-mg dose, demonstrated efficacy in reducing symptom duration in patients with mild to moderate COVID-19, without new safety concerns. These findings highlight ensitrelvir as a potential treatment option for COVID-19, pending confirmation of generalizability to populations outside of Asia.
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