Effects of leritrelvir for adults with mild-to-moderate coronavirus disease 2019: A multicenter real-world study
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background: Real-world evidence for leritrelvir, a single-component 3C-like protease inhibitor, in adults with mild-to-moderate coronavirus disease 2019 (COVID-19) remains limited. We evaluated the association of early leritrelvir use with symptom resolution, negative viral-test conversion, and adverse events in routine clinical practice. Methods: This prospective, multicenter, nonrandomized, open-label observational cohort study was conducted at 141 sites in China (mainland ). Among 1,527 adults with mild-to-moderate COVID-19, 1,388 received leritrelvir (400 mg three times daily for 5 days) plus standard care and 139 received standard care alone. The primary endpoint was time to sustained resolution of 11 predefined symptoms. The key secondary endpoint was time to negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test (NAT) conversion. All participants contributed a primary time-to-event record. We estimated unadjusted and multivariable-adjusted Cox models and performed 1:1 propensity score (PS) matching (136 participants per group). Results: For sustained symptom resolution, the unadjusted hazard ratio (HR) was 1.41 [95% confidence interval (CI): 1.18-1.68; P<0.001], the multivariable-adjusted HR was 1.66 (95% CI: 1.38-1.99; P<0.001), and the PS-matched HR was 1.81 (robust 95% CI: 1.43-2.29; P<0.001). In the matched cohort, median time to symptom resolution was 6 days with leritrelvir and 8 days with standard care alone. For negative NAT conversion, the corresponding HRs were 1.20 (95% CI: 1.01-1.43; P=0.04), 1.22 (95% CI: 1.01-1.47; P=0.04), and 1.47 (robust 95% CI: 1.21-1.79; P<0.001); matched medians were 3 and 4 days. Adverse events occurred in 22.41% and 19.42% of the unmatched groups, respectively. Conclusions: In this prospective, multicenter, nonrandomized cohort, leritrelvir use was associated with earlier sustained symptom resolution and negative SARS-CoV-2 NAT conversion than standard care alone. Although the direction of association was consistent across multivariable-adjusted and PS-matched analyses, residual confounding, open-label symptom assessment, nonproportional hazards, incomplete follow-up, and the absence of severe-outcome events preclude causal, subgroup-specific, or severe-outcome conclusions.
Source: Journal of Thoracic Disease
Authors: Lin-Ling Cheng, Ming-Qing Lu, Bang-Han Ding, Hui-Qing Zeng, Tian-Xin Xiang, Wei-Dong Weng, Xu-Jing Liang, Jie Jin, Zi-Hao Liu, Hai-Ping Dong, Hui-Lin Wang, Chen-Li Xie, Run-Qi Luo, Xue-Bing Rong, Li-Li Yue, Jun-Rui Li, Feng Li, Yu-Ping Wei, San-Jing Li, Chao Xu, Chi-Guan Li, Hong-Yan Yu, Fei Wei, Wen-Quan Li, Hui-Feng Wang, Chuan-Liu Yang, Bang-Qiong Weng, Liang Wang, De-Qiang Wang, Peng-Yu Zhang, Zheng-Hao Tang, Zi-Feng Yang, Jian-Xing He, Nan-Shan Zhong
Institutions: First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, Guangzhou Laboratory, Guangzhou Institute of Respiratory Health, Guangdong Provincial Hospital of Chinese Medicine, Fujian Medical University, Nanchang University, First Affiliated Hospital of Nanchang University, First Affiliated Hospital of Jinan University, First Affiliated Hospital Zhejiang University, Guangzhou Chest Hospital, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Baoding People's Hospital, Tangshan People's Hospital, Henan University of Science and Technology, The Sixth People's Hospital of Zhengzhou, Zhengzhou Central Hospital, Hebei University of Engineering, Second People’s Hospital of Yibin, Shanghai First People's Hospital, Shanghai Sixth People's Hospital
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7224121883