Fuzheng Jiedu granules against disease progression among high-risk adults with non-severe COVID-19: a multicentre retrospective cohort study

Zhongde Zhang ^1,2* Qiaoli Hua ³ Danwen Zheng ² Shui Jingwei ² Tong Zhang ² Ping Tan ⁴ Bo Yu ⁵ Longde Wang ⁶ Hailang He ⁷ Xinghua Tan ⁸ Qiumin Chen ⁹ Yang Yang ¹⁰ Weng Heng ² Yihang Cai ² Xu Xiaohua ² Qing Liu ² Yuntao Liu ² Rongyuan Yang ²

• ¹ Guangdong Provincial Key Laboratory of Research on Emergency in TCM, Guangzhou, China, Guangzhou, China
• ² the second affiliated hospital of Guangzhou university of Chinese medicine, Guangzhou, China
• ³ Shenzhen Traditional Chinese Medicine Hospital, Shenzhen ，Guangdong, China
• ⁴ Hainan Provincial Hospital of Traditional Chinese Medicine, Haikou, Hainan Province, China
• ⁵ The No.2 People’s Hospital of Lanzhou, Lanzhou, China
• ⁶ Affiliated Hospital of Gansu University of Traditional Chinese Medicine, Lanzhou, Gansu Province, China
• ⁷ Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu Province, China
• ⁸ Guangzhou Eighth People's Hospital, Guangzhou, Guangdong Province, China
• ⁹ First Affiliated Hospital of Xiamen University, Xiamen, Fujian Province, China
• ¹⁰ Dalian Hospital of Traditional Chinese Medicine, Dalian, Liaoning Province, China

Background: Fuzheng Jiedu (FZJD) granules are widely used to treat coronavirus disease (COVID-19) since its market approval, but their clinical effectiveness remains uncertain. This study aimed to evaluate the effectiveness of FZJD in reducing disease progression in high-risk adults with COVID-19. Methods: A multicenter, retrospective cohort study involving high-risk adults with non-severe COVID-19 was conducted in China from May 2021 to December 2022. The study was registered at Chinese Clinical Trial Registry (ChiCTR2200058097; https://www.chictr.org.cn/bin/project/edit?pid=160010). Patients were divided into two groups based on the administration of FZJD. The outcomes included disease progression, mechanical ventilation, intensive care unit (ICU) admission, and mortality. Propensity-score analyses and multivariable regression were performed to assess the effectiveness of FZJD. The effectiveness was further analyzed in different subgroups. Results: A total of 1644 patients (54.7% female; mean age, 62.3 years) were included, with 27.4% (451/1644) receiving FZJD. After propensity score matching (PSM), 320 FZJD receivers and 320 non-receivers were matched. Compared with those not receiving FZJD, receiving FZJD was associated with lower risks of disease progression (adjusted odds ratio [OR], 0.21; 95% confidence interval [CI], 0.06-0.73), mechanical ventilation (OR, 0.15; [95% CI, 0.03-0.66]), and ICU admission (OR, 0.08; [95% CI, 0.01-0.64]). The lower risk of disease progression in the FZJD group was confirmed by multivariable regression analysis and various propensity-score analyses. Furthermore, subgroup analyses demonstrated significant treatment benefits in patients with moderate COVID-19 at admission (no patients progression to severe disease) or in those who were not fully vaccinated (OR, 0.06; [95% CI, 0.01-0.50]). Fuzheng Jiedu granules against disease progression among high-risk adults 3 Conclusion: FZJD administration was significantly associated with a reduced risk of disease progression in high-risk adults with mild-to-moderate COVID-19.