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Background <p>Remdesivir has been established as a safe treatment for patients with COVID-19. However, given the SARS-CoV-2 random mutations, 3CL protease inhibitors have been studied in recent randomized controlled trials. Therefore, this meta-analysis aims to compare 3CL protease inhibitors versus placebo in patients with mild to moderate COVID-19.</p> Methods <p>We systematically searched PubMed, Embase, and Cochrane Central for RCTs comparing the treatment regimens in patients with mild to moderate COVID-19. Outcomes of interest were the number of patients with symptomatic resolution, recovery rates, viral load change from baseline, alleviation rates, any adverse events, and serious/severe adverse events. Risk ratios (RRs) and hazard ratios (HRs) with 95% CI were calculated for binary outcomes, and standardized mean differences (SMDs) were calculated for continuous outcomes. R version 4.3.2 was used for statistical analysis with the random effects model.</p> Results <p>Ten studies were included, comprising 8,511 patients, of whom 4,654 (55.97%) received 3CL protease inhibitors. Follow-up ranged from 21 to 29 months. In our time-to-event analysis, 3CL protease inhibitors significantly increased the rate of alleviation (HR 1.17; 95% CI [1.09;1.25]; <i>p</i> &lt; 0.01), and recovery rates (HR 1.18; 95% CI [1.11;1.26]; <i>p</i> &lt; 0.01) in patients with mild to moderate COVID-19. However, 3CL protease inhibitors significantly reduced viral load at 72&#xa0;h (SMD − 0.95; 95% CI [-1.23; -0.66]; <i>p</i> &lt; 0.01) compared with placebo in these patients. There was no significant difference between groups in symptomatic resolution (RR 1.01; 95% CI [1.00;1.03]; <i>p</i> = 0.147).</p> Conclusion <p>3CL protease inhibitors significantly reduced the change in the viral load and increased the rate of symptom alleviation and recovery, underscoring their importance as a potential therapeutic option.</p>

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Efficacy and safety of 3CL protease inhibitors in patients with mild or moderate COVID-19: a systematic review and meta-analysis of randomized controlled trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月21日

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  • Nicole Jean Lee,
  • Eric Shih Katsuyama,
  • Christian Ken Fukunaga,
  • Wilson Falco Neto,
  • Ana Carolina Covre Coan,
  • Hilaria Saugo Faria,
  • Eduardo Alexandrino Medeiros

摘要

Background

Remdesivir has been established as a safe treatment for patients with COVID-19. However, given the SARS-CoV-2 random mutations, 3CL protease inhibitors have been studied in recent randomized controlled trials. Therefore, this meta-analysis aims to compare 3CL protease inhibitors versus placebo in patients with mild to moderate COVID-19.

Methods

We systematically searched PubMed, Embase, and Cochrane Central for RCTs comparing the treatment regimens in patients with mild to moderate COVID-19. Outcomes of interest were the number of patients with symptomatic resolution, recovery rates, viral load change from baseline, alleviation rates, any adverse events, and serious/severe adverse events. Risk ratios (RRs) and hazard ratios (HRs) with 95% CI were calculated for binary outcomes, and standardized mean differences (SMDs) were calculated for continuous outcomes. R version 4.3.2 was used for statistical analysis with the random effects model.

Results

Ten studies were included, comprising 8,511 patients, of whom 4,654 (55.97%) received 3CL protease inhibitors. Follow-up ranged from 21 to 29 months. In our time-to-event analysis, 3CL protease inhibitors significantly increased the rate of alleviation (HR 1.17; 95% CI [1.09;1.25]; p < 0.01), and recovery rates (HR 1.18; 95% CI [1.11;1.26]; p < 0.01) in patients with mild to moderate COVID-19. However, 3CL protease inhibitors significantly reduced viral load at 72 h (SMD − 0.95; 95% CI [-1.23; -0.66]; p < 0.01) compared with placebo in these patients. There was no significant difference between groups in symptomatic resolution (RR 1.01; 95% CI [1.00;1.03]; p = 0.147).

Conclusion

3CL protease inhibitors significantly reduced the change in the viral load and increased the rate of symptom alleviation and recovery, underscoring their importance as a potential therapeutic option.