Clinical Characteristics of Severe COVID-19 Patients During Omicron Epidemic and a Nomogram Model Integrating Cell-Free DNA for Predicting Mortality: A Retrospective Analysis

Lu et al., Infection and Drug Resistance, doi:10.2147/IDR.S430101

Oct 2023

Retrospective 282 severe COVID-19 patients, showing no significant difference in mortality with paxlovid in unadjusted results.

Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid Hoertel. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.

Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid" FDA.

1. FDA, Fact sheet for healthcare providers: emergency use authorization for paxlovid, www.fda.gov/media/155050/download.fda.gov.

2. Hoertel et al., Prevalence of Contraindications to Nirmatrelvir-Ritonavir Among Hospitalized Patients With COVID-19 at Risk for Progression to Severe Disease, JAMA Network Open, doi:10.1001/jamanetworkopen.2022.42140.jamanetwork.com, doi.org.

Important missing comments or errors? Let us know.

risk of death, 5.9% higher, RR 1.06, p = 0.84, treatment 17 of 29 (58.6%), control 140 of 253 (55.3%).

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Lu et al., 18 Oct 2023, retrospective, China, peer-reviewed, 11 authors, study period 26 September, 2022 - 27 April, 2023. Contact: sypan@njmu.edu.cn.

This Paper Paxlovid All

Clinical Characteristics of Severe COVID-19 Patients During Omicron Epidemic and a Nomogram Model Integrating Cell-Free DNA for Predicting Mortality: A Retrospective Analysis

Yanfei Lu, Wenying Xia, Shuxian Miao, Min Wang, Lei Wu, Ting Xu, Fang Wang, Jian Xu, Yuan Mu, Bingfeng Zhang, Shiyang Pan

Infection and Drug Resistance, doi:10.2147/idr.s430101

Objective: This study aimed to investigate the clinical characteristics and risk factors of death in severe coronavirus disease 2019 (COVID-19) during the epidemic of Omicron variants, assess the clinical value of plasma cell-free DNA (cfDNA), and construct a prediction nomogram for patient mortality. Methods: The study included 282 patients with severe COVID-19 from December 2022 to January 2023. Patients were divided into survival and death groups based on 60-day prognosis. We compared the clinical characteristics, traditional laboratory indicators, and cfDNA concentrations at admission of the two groups. Univariate and multivariate logistic analyses were performed to identify independent risk factors for death in patients with severe COVID-19. A prediction nomogram for patient mortality was constructed using R software, and an internal validation was performed. Results: The median age of the patients included was 80.0 (71.0, 86.0) years, and 67.7% (191/282) were male. The mortality rate was 55.7% (157/282). Age, tracheal intubation, shock, cfDNA, and urea nitrogen (BUN) were the independent risk factors for death in patients with severe COVID-19, and the area under the curve (AUC) for cfDNA in predicting patient mortality was 0.805 (95% confidence interval [CI]: 0.713-0.898, sensitivity 81.4%, specificity 75.6%, and cut-off value 97.67 ng/mL). These factors were used to construct a prediction nomogram for patient mortality (AUC = 0.856, 95% CI: 0.814-0.899, sensitivity 78.3%, and specificity 78.4%), C-index was 0.856 (95% CI: 0.832-0.918), mean absolute error of the calibration curve was 0.007 between actual and predicted probabilities, and Hosmer-Lemeshow test showed no statistical difference (χ2=6.085, P=0.638). Conclusion: There was a high mortality rate among patients with severe COVID-19. cfDNA levels ≥97.67 ng/mg can significantly increase mortality. When predicting mortality in patients with severe COVID-19, a nomogram based on age, tracheal intubation, shock, cfDNA, and BUN showed high accuracy and consistency.

Disclosure The authors report no conflicts of interest in this work.

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