Retrospective 1,281 COVID-19 patients with comorbidities in China, showing 2% lower mortality with paxlovid.
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.
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risk of death, 2.0% lower, OR 0.98, p = 0.04, treatment 220, control 1,061, adjusted per study, multivariable, RR approximated with OR.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Yang et al., 22 Jun 2023, retrospective, China, preprint, mean age 70.5, 22 authors, study period 1 March, 2022 - 30 June, 2022.
Contact:
jwx02467@gmail.com, ff4719@yahoo.com, bai.chunxue@zs-hospital.sh.cn, ylsong70@163.com, yang.dawei@zs-hospital.sh.cn, whf6296@163.com, lijing@centennialsci.com, 854719218@qq.com, ju.minjie@zs-hospital.sh.cn, wang.hao@zs-hospital.sh.cn, jia.yicheng@zs-hospital.sh.cn, wang.xiaodan@zs-hospital.sh.cn, fan.jia@zs-hospital.sh.cn, yan.zuoqin@zs-hospital.sh.cn, zhou.jian@fudan.edu.cn, chencuicui001@126.com, yinzhoufeng@163.com, 624630944@qq.com, houdn2014@126.com, luxingwei@centennialsci.com, johnny.yang@suvalue.com, grace.wu@suvalue.com.
Clinical prognosis and risk factors of death for COVID-19 patients complicated with coronary heart disease/diabetes/hypertension-a retrospective, real-world study
Da-Wei Yang, Hui-Fen Weng, Jing Li, Zheng-Guo Chen, Min-Jie Ju, Hao Wang, Yi-Chen Jia, Xiao-Dan Wang, Jia Fan, Zuo-Qin Yan, Jian Zhou, Cui-Cui Chen, Yin-Zhou Feng, Xiao-Yan Chen, Dong-Ni Hou, Xing-Wei Lu, Wei Yang, Yin Wu, Xiao-Han Hu, Jian-Wei Xuan, Chunxue Bai, Yuanlin Song
Objectives ： To explore the clinical prognosis and the risk factors of death of COVID-19 patients complicated with one of the three major comorbidities (coronary heart disease, diabetes， or hypertension) based on real-world data. Methods: This single-center retrospective real-world study investigated all in-hospital patients who were transferred to the Coronavirus Special Ward of the Elderly Center of Zhongshan Hospital from March to June 2022 with a positive COVID-19 virus nucleic acid test and with at least one of the three comorbidities (coronary heart disease, diabetes or hypertension). Clinical data and laboratory test results of eligible patients were collected.A multivariate logistic regression analysis was performed to explore the risk associated with the prognosis. Results：For the 1,281 PCR positive patients at the admission included in the analysis, the mean age was 70.5±13.7 years and 658 (51.4%) were males. There were 1,092 (85.2%) patients with hypertension, 477(37.2%) patients with diabetes, and 124 (9.7%) patients with coronary heart disease. The length of hospital stay (LOS) was 9.2±5.1 days. Among all admitted patients,1112 (91.5%) were fully recovered, 77 (6.9%) were improved, and 29 (2.6%) died. Over the hospitalization, 172 (13.4%) PCR positive patients experienced rebound COVID following initial recovery with negative PCR test. A multivariate logistic regression analysis showed that vaccination had no protective effects in this study population; Paxlovid was associated with a lower risk of death(OR =0 .98, 95% CI: 0.95-1.00). Whereas, presence of solid malignancies and nerve system disease were significantly associated with increased risk of death (OR=1.04, 95%
Conflict of Interest Huifen Weng, Lijing, Xingwei Lu were employed by Shanghai Centennial Scientific Co., Ltd. Shanghai, China.Wei Yang were employed by Shanghai Suvalue Healthcare Scientific Co., Ltd. Shanghai, China. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4488145 P r e p r i n t n o t p e e r r e v i e w e d
Appendix Table 1A COVID-19 Diagnosis and Treatment Protocol (Trial Version 9)
Clinical type Clinical symptoms
Mild The clinical symptoms were mild, and no pneumonia was observed on imaging.
Moderate With the above clinical manifestations, imaging findings of pneumonia. This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4488145 P r e p r i n t n o t p e e r r e v i e w e d
12/13 Severe Adults meet any of the following criteria :1. Shortness of breath, RR ≥ 30 times/min; 2. In the resting state, oxygen saturation ≤ 93% when inhaling air; Arterial partial pressure of oxygen (PaO2) / oxygen concentration (FiO2) ≤ 300mmHg (1mmHg = 0.133kPa); The PaO2/FiO2 should be calibrated according to the following formula for high altitudes (above 1000m): PaO2/FiO2×[760/ atmospheric pressure (mmHg)]. 4. The clinical symptoms were progressively aggravated, and the..
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