Data_Sheet_1_Early carbohydrate antigen 125 as a mortality predictor in hospitalized patients with coronavirus disease 2019.docx

BackgroundCarbohydrate antigen 125 (CA125) is an indicator of inflammation, immune response, and impaired cardiac function. The aim was to investigate whether CA125 behaves as a biomarker of severity and poor clinical outcomes in hospitalized patients with coronavirus disease 2019 (COVID-19).
MethodsSerum CA125 [Elecsys CA125 II assay-(Roche Diagnostics GmbH)] was measured in stored biobank samples from COVID-19 hospitalized patients between 01 March 2020 and 17 October 2021. Multiple logistic regression models were built to explore the association between CA125 and clinical outcomes [in-hospital all-cause mortality, need for invasive mechanical ventilation (IMV), or non-invasive respiratory support (non-IRS)], estimating odds ratios (ORs; 95% CI). The gradient of risk of CA125 was evaluated by fractional polynomials.
ResultsA total of 691 patients were included, median age of 63 years (50–76), men (57.2%), with high comorbidity. At admission, 85.8% had pneumonia. Median CA125 was 10.33 U/ml (7.48–15.50). The in-hospital mortality rate was 7.2%. After adjusting for confounding factors, CA125 ≥ 15.5 U/ml (75th percentile) showed an increased risk of death [OR 2.85(1.21–6.71)], as age ≥ 65 years, diabetes, and immunosuppression. Furthermore, CA125 as a continuous variable was positive and significantly associated with the risk of death after multivariate adjustment. The mean hospital stay of the patients with CA125 ≥ 15.5 U/ml was longer than the rest of the study population.
ConclusionCA125 in the first 72 h of hospital admission seems a useful biomarker of mortality in hospitalized patients with moderate–severe COVID-19. If our findings are confirmed, the wide availability of this biomarker would make easy its widespread implementation in clinical practice.

背景：糖类抗原125（Carbohydrate antigen 125，CA125）是反映炎症、免疫应答及心功能受损的生物学指标。本研究旨在探讨糖类抗原125能否作为新型冠状病毒肺炎（COVID-19）住院患者病情严重程度及不良临床结局的生物标志物。
方法：本研究于2020年3月1日至2021年10月17日期间，对新型冠状病毒肺炎住院患者的储存在生物样本库中的血清样本进行糖类抗原125（CA125）检测，检测采用Elecsys CA125 II检测试剂盒（罗氏诊断有限公司，Roche Diagnostics GmbH）。本研究构建多因素logistic回归模型，以探讨CA125与临床结局[包括住院期间全因死亡率、有创机械通气（Invasive Mechanical Ventilation，IMV）需求及无创呼吸支持（Non-Invasive Respiratory Support，non-IRS）需求]之间的关联，并计算比值比（Odds Ratios，ORs；95%置信区间，95% CI）。本研究采用分数多项式法评估CA125的风险梯度。
结果：本研究共纳入691例患者，患者中位年龄为63岁（四分位间距：50~76岁），男性占比57.2%，合并症负担较重。入院时，85.8%的患者合并肺炎。受试者血清CA125中位值为10.33 U/ml（四分位间距：7.48~15.50 U/ml），住院期间全因死亡率为7.2%。在校正混杂因素后，血清CA125≥15.5 U/ml（即第75百分位数）的患者死亡风险升高[OR=2.85，95%CI：1.21~6.71]，该结果与年龄≥65岁、糖尿病及免疫抑制状态的死亡风险升高趋势一致。此外，经多变量校正后，作为连续变量的CA125水平与死亡风险呈显著正相关。血清CA125≥15.5 U/ml的患者平均住院时长显著长于其余研究对象。
结论：住院首72小时内检测的血清CA125可作为中重度新型冠状病毒肺炎住院患者死亡风险的有效生物标志物。若本研究结果得以验证，由于该生物标志物检测便捷且普及度高，有望在临床实践中广泛推广应用。