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.
Reference:
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.