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Background <p>Cell-free DNA (cfDNA) has emerged as a relevant biomarker reflecting disease severity in hospitalised COVID-19 patients, correlating with respiratory failure and mortality. However, its utility has not yet been evaluated in general practitioner setting.</p> Methods <p>A prospective single-centre, two-arm, parallel, longitudinal cohort study conducted in a German general practice with four doctors between 8/2021 and 4/2022. <i>Participants</i>: Sixty-one outpatients with flu-like symptoms participated: 31 (10 men, 21 women) tested SARS-CoV-2 positive (COVID group); 30 (12 men, 18 women) were controls (control group). The groups were demographically similar. <i>Primary outcome measures</i>: Comparison of cfDNA levels between groups at day 0, 7 and 14. <i>Secondary outcome measures</i>: Correlations between cfDNA levels and laboratory and clinical parameters like blood counts, respiratory rate and oxygen saturation.</p> Results <p>cfDNA levels did not differ significantly between groups (F [1, 59] = 1.538, <i>p</i> = 0.22): day 0: mean (± standard deviation) = 14.45 (± 6.24) ng/ml (COVID group) vs. 11.32 (± 4.79) ng/ml (control group); day 7: 14.46 (± 6.57) ng/ml vs. 12.53 (± 6.67) ng/ml; day 14: 12.94 (± 6.66) ng/ml vs. 12.93 (± 7.02) ng/ml. However, at t0, the integrity index was significantly lower in the COVID group (t0: 0.30 [±- 0.15] vs. 0.41 [± 0.1]; <i>p</i> = 0.0127) increasing at t1 (0.38 [± 0.17]; <i>p</i> = 0.008) and at t2 (0.42 [± 0.22]; <i>p</i> &lt; 0.001).</p> Conclusion <p>Unlike hospitalised patients, cfDNA levels did not differ significantly between outpatient groups. Therefore, a decision on the need for hospitalisation based on clinical and serological factors is still required. The significantly lower integrity index of the SARS-CoV-2 infected individuals indicates that their DNA kinetics differ from those of individuals infected with other respiratory pathogens.</p> Trial registration <p>: German Clinical Trials Register: DRKS00024722, Registration date: 10 March 2021.</p>

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CfDNA as a surrogate marker for COVID-19 severity in patients with influenza-like symptoms with and without SARS-CoV-2 infection in general practice: a prospective cohort study

  • 期刊论文

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  • 发表日期：

    2025年12月1日

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  • Dorothea Dehnen,
  • Suzan Botzenhardt,
  • Ekaterini Giagkou,
  • Kira Enders,
  • Katharina Hoeter,
  • Perikles Simon,
  • Elmo W.I. Neuberger

摘要

Background

Cell-free DNA (cfDNA) has emerged as a relevant biomarker reflecting disease severity in hospitalised COVID-19 patients, correlating with respiratory failure and mortality. However, its utility has not yet been evaluated in general practitioner setting.

Methods

A prospective single-centre, two-arm, parallel, longitudinal cohort study conducted in a German general practice with four doctors between 8/2021 and 4/2022. Participants: Sixty-one outpatients with flu-like symptoms participated: 31 (10 men, 21 women) tested SARS-CoV-2 positive (COVID group); 30 (12 men, 18 women) were controls (control group). The groups were demographically similar. Primary outcome measures: Comparison of cfDNA levels between groups at day 0, 7 and 14. Secondary outcome measures: Correlations between cfDNA levels and laboratory and clinical parameters like blood counts, respiratory rate and oxygen saturation.

Results

cfDNA levels did not differ significantly between groups (F [1, 59] = 1.538, p = 0.22): day 0: mean (± standard deviation) = 14.45 (± 6.24) ng/ml (COVID group) vs. 11.32 (± 4.79) ng/ml (control group); day 7: 14.46 (± 6.57) ng/ml vs. 12.53 (± 6.67) ng/ml; day 14: 12.94 (± 6.66) ng/ml vs. 12.93 (± 7.02) ng/ml. However, at t0, the integrity index was significantly lower in the COVID group (t0: 0.30 [±- 0.15] vs. 0.41 [± 0.1]; p = 0.0127) increasing at t1 (0.38 [± 0.17]; p = 0.008) and at t2 (0.42 [± 0.22]; p < 0.001).

Conclusion

Unlike hospitalised patients, cfDNA levels did not differ significantly between outpatient groups. Therefore, a decision on the need for hospitalisation based on clinical and serological factors is still required. The significantly lower integrity index of the SARS-CoV-2 infected individuals indicates that their DNA kinetics differ from those of individuals infected with other respiratory pathogens.

Trial registration

: German Clinical Trials Register: DRKS00024722, Registration date: 10 March 2021.