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Background <p>Critical care admissions due to breakthrough COVID-19 in fully vaccinated patients remain rare. There is limited data on their characteristics and outcomes compared to non- or partially vaccinated patients, and no studies have evaluated the impact of variants of concern.</p> Method <p>This study used the COMETE-19 (COVID-19 patients in the intensive care unit [ICU]) near real-time prospective registry, a tool launched on March 1, 2020, to track patient and disease characteristics as well as the disease course of critically ill COVID-19 patients in two French ICUs. Fully vaccinated patients were compared with non- or partially vaccinated patients. The primary outcome was a composite criterion of severity, including invasive mechanical ventilation (IMV), other organ assistance, or death. Differences between the vaccinated and control groups regarding other outcomes, patient variables, management, and SARS-CoV-2 variants were explored using univariate analysis. Factors associated with high disease severity in both groups were examined using logistic regression analysis.</p> Results <p>A total of 805 patients (median age, 65 years [IQR 56–71], 67% male) were enrolled. Of these, 41 (5%) were fully vaccinated. Fully vaccinated patients required less frequent IMV (27% vs. 51%, <i>p</i> = 0.003) and had lower mortality (15% vs. 26%, <i>p</i> = 0.026). Full vaccination status was associated with lower disease severity (OR 0.30; CI95% [0.11–0.74]; <i>p</i> = 0.011) and tended to prevent ICU mortality (OR 0.39, CI95% [0.13–1.04], <i>p</i> = 0.072). Variants-of-concern did not associate with outcomes.</p> Conclusion <p>Among critically ill COVID-19 patients, full vaccination was associated with less severe disease progression compared to partial or no vaccination.</p> Trial Registration <p>Clinical Trial: NCT04430322</p>

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Comparison of fully-vaccinated and non/partially-vaccinated critically-ill COVID-19 patients in terms of disease severity: a retrospective observational study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月31日

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  • Guillaume Louis,
  • Vincent Dinot,
  • Thibaut Belveyre,
  • Ophélie Dirand,
  • Paul Dunand,
  • Cyril Cadoz,
  • Rostane Gaci,
  • Sébastien Gette,
  • Pascale Perez,
  • Christophe Goetz,
  • Yoann Picard,
  • Nouchan Mellati

摘要

Background

Critical care admissions due to breakthrough COVID-19 in fully vaccinated patients remain rare. There is limited data on their characteristics and outcomes compared to non- or partially vaccinated patients, and no studies have evaluated the impact of variants of concern.

Method

This study used the COMETE-19 (COVID-19 patients in the intensive care unit [ICU]) near real-time prospective registry, a tool launched on March 1, 2020, to track patient and disease characteristics as well as the disease course of critically ill COVID-19 patients in two French ICUs. Fully vaccinated patients were compared with non- or partially vaccinated patients. The primary outcome was a composite criterion of severity, including invasive mechanical ventilation (IMV), other organ assistance, or death. Differences between the vaccinated and control groups regarding other outcomes, patient variables, management, and SARS-CoV-2 variants were explored using univariate analysis. Factors associated with high disease severity in both groups were examined using logistic regression analysis.

Results

A total of 805 patients (median age, 65 years [IQR 56–71], 67% male) were enrolled. Of these, 41 (5%) were fully vaccinated. Fully vaccinated patients required less frequent IMV (27% vs. 51%, p = 0.003) and had lower mortality (15% vs. 26%, p = 0.026). Full vaccination status was associated with lower disease severity (OR 0.30; CI95% [0.11–0.74]; p = 0.011) and tended to prevent ICU mortality (OR 0.39, CI95% [0.13–1.04], p = 0.072). Variants-of-concern did not associate with outcomes.

Conclusion

Among critically ill COVID-19 patients, full vaccination was associated with less severe disease progression compared to partial or no vaccination.

Trial Registration

Clinical Trial: NCT04430322