SynthesisInfection2025
Efficacy and safety of Ensitrelvir in asymptomatic or mild to moderate COVID-19: a systematic review and meta-analysis of randomized controlled trials.
Synthesis in Infection, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Strategic Preparedness of Broad-Spectrum Antivirals for Rapid Response Towards Next Pandemics.Small science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSince late 2019, COVID-19 has had a catastrophic impact on public health. Ensitrelvir, a new antiviral targeting the SARS-CoV-2 main protease, has reduced viral replication and disease severity. This meta-analysis and systematic review assessed Ensitrelvir's efficacy and safety in patients with mild-to-moderate COVID-19 symptoms.
methodsA comprehensive search was conducted in PubMed (Medline), Scopus, Embase, and CENTRAL up to July 2024 to retrieve randomized controlled trials (RCTs) comparing Ensitrelvir to placebo in adults with mild to moderate, RT-PCR-confirmed COVID-19. Outcomes were assessed at standardized time points, with viral RNA measured at day 4. Mean differences (MD) for continuous outcomes and risk ratios (RR) for binary outcomes, both with 95% confidence intervals (CIs), were calculated using the Mantel-Haenszel random-effects model. Efficacy outcomes included SARS-CoV-2 viral RNA, while safety outcomes included HDL, triglycerides, bilirubin, AST, headache, diarrhea, TEAEs, TRAEs, serious TEAEs, and treatment discontinuation. The quality of the included RCTs was assessed with the Cochrane Risk of Bias 2 (ROB2) tool.
resultsThe analysis included six RCTs with 2,793 participants: 1,860 received Ensitrelvir and 933 were given a placebo. Ensitrelvir gave significant results for reduced viral RNA levels of SARS-CoV-2 [MD: - 1.35; 95% CI - 1.58 to - 1.13; p < 0.01] and the incidence of lower cholesterol levels [RR: 8.83; 95% CI 4.05 to 19.27; p < 0.01] compared to the placebo group. However, it was associated with increased risks of decreased HDL levels, elevated triglycerides, increased bilirubin, more headaches, and a higher overall occurrence of treatment-emergent adverse events.
conclusionEnsitrelvir effectively reduces viral load in COVID-19 patients, but its safety profile raises concerns due to significant adverse effects. The benefits must be carefully weighed against the risks, and further research is needed to confirm its role in treatment and to find ways to mitigate these adverse effects.
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