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Background <p>Coronavirus Disease (COVID-19), which is caused by SARS-CoV-2 virus, led to a worldwide pandemic in late 2019, thus challenged the healthcare infrastructure across the world, creating an urgent need for the development of effective antiviral medications to handle its spread and evolving strains.</p> Objective <p>This Meta-Analysis aims to investigate the overall efficacy and safety of Ensitrelvir.</p> Methods <p>We conducted a systematic review and meta-analysis, according to PRISMA guidelines, searching web databases for relevant literature. We limited our eligibility to randomized clinical trials involving mild-to-moderate COVID-19 patients.</p> Results <p>Our study included four randomized controlled trials involving a total of 2,890 patients. For patients with mild-to-moderate Covid-19, treatment with Ensitrelvir (125&#xa0;mg or 250&#xa0;mg) was associated with significantly improved outcomes compared to placebo across several metrics: higher viral clearance was observed for 125&#xa0;mg [MD = − 37.74, <i>P</i> &lt; 0.00001] and 250&#xa0;mg [MD = − 35.02, <i>P</i> &lt; 0.00001]; greater reductions in viral RNA were achieved by 125&#xa0;mg [MD = -1.41, <i>P</i> &lt; 0.00001] and 250&#xa0;mg [MD = -1.37, <i>P</i> &lt; 0.00001]; and a significantly lower proportion of patients maintained a positive viral titer at 125&#xa0;mg [RR 0.08, <i>P</i> &lt; 0.00001, I<sup>2</sup> = 82%] and 250&#xa0;mg [RR 0.10, <i>P</i> &lt; 0.00001, I<sup>2</sup> = 16%]. Ultimately, there were no significant differences in reported outcomes between the 125&#xa0;mg and 250&#xa0;mg Ensitrelvir dosage groups.</p> Conclusion <p>This systematic review and meta-analysis support Ensitrelvir efficacy and safety in promoting rapid viral clearance and greater reduction in viral RNA in mild-to-moderate or asymptomatic COVID-19 patients, justifying its integration into outpatient treatment protocols while emphasizing the need for further large-scale, variant-inclusive studies to validate and extend these findings.</p> Registration <p>PROSPERO (CRD420251030953).</p>

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Efficacy and safety of Ensitrelvir in COVID-19 patients: a systematic review and meta-analysis with focus on viral clearance and RNA change

  • 期刊论文

  • 发表日期：

    2026年6月29日

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  • Shahd Nofal,
  • Osama Al-said,
  • Khaled Alnimer,
  • Jood Mudar Sarah,
  • Tala Abu Alam,
  • Omar Ali,
  • Dua Abuquteish

摘要

Background

Coronavirus Disease (COVID-19), which is caused by SARS-CoV-2 virus, led to a worldwide pandemic in late 2019, thus challenged the healthcare infrastructure across the world, creating an urgent need for the development of effective antiviral medications to handle its spread and evolving strains.

Objective

This Meta-Analysis aims to investigate the overall efficacy and safety of Ensitrelvir.

Methods

We conducted a systematic review and meta-analysis, according to PRISMA guidelines, searching web databases for relevant literature. We limited our eligibility to randomized clinical trials involving mild-to-moderate COVID-19 patients.

Results

Our study included four randomized controlled trials involving a total of 2,890 patients. For patients with mild-to-moderate Covid-19, treatment with Ensitrelvir (125 mg or 250 mg) was associated with significantly improved outcomes compared to placebo across several metrics: higher viral clearance was observed for 125 mg [MD = − 37.74, P < 0.00001] and 250 mg [MD = − 35.02, P < 0.00001]; greater reductions in viral RNA were achieved by 125 mg [MD = -1.41, P < 0.00001] and 250 mg [MD = -1.37, P < 0.00001]; and a significantly lower proportion of patients maintained a positive viral titer at 125 mg [RR 0.08, P < 0.00001, I2 = 82%] and 250 mg [RR 0.10, P < 0.00001, I2 = 16%]. Ultimately, there were no significant differences in reported outcomes between the 125 mg and 250 mg Ensitrelvir dosage groups.

Conclusion

This systematic review and meta-analysis support Ensitrelvir efficacy and safety in promoting rapid viral clearance and greater reduction in viral RNA in mild-to-moderate or asymptomatic COVID-19 patients, justifying its integration into outpatient treatment protocols while emphasizing the need for further large-scale, variant-inclusive studies to validate and extend these findings.

Registration

PROSPERO (CRD420251030953).