Effects of leritrelvir for adults with mild-to-moderate coronavirus disease 2019: a multicenter real-world study.
30 affiliations
- 1State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
- 2Guangzhou National Laboratory, Guangzhou, China.
- 3Emergency Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.
- 4Teaching Hospital of Fujian Medical University, Xiamen, China.
- 5Department of Infectious Diseases, The First Affiliated Hospital of Nanchang University, Nanchang University, Nanchang, China.
- 6Zhejiang Institute of Traditional Chinese Medicine, Hangzhou, China.
- 7Division of Infectious Disease, The First Affiliated Hospital of Jinan University, Guangzhou, China.
- 8Key Laboratory of Hematopoietic Malignancies, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.
- 9Department of Severe Tuberculosis Medicine, Guangzhou Chest Hospital, Guangzhou, China.
- 10Zhengzhou Third People's Hospital, Zhengzhou, China.
- 11Dongguan Binhai Bay Central Hospital, Dongguan, China.
- 12Department of Infectious Diseases, The Second Affiliated Hospital Guangzhou Medical University, Guangzhou, China.
- 13Baoding First Hospital, Baoding, China.
- 14Luoyang First People's Hospital, Luoyang, China.
- 15Tangshan Central Hospital, Tangshan, China.
- 16The Second Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
- 17Chizhou People's Hospital, Chizhou, China.
- 18Zhengzhou Sixth People's Hospital, Zhengzhou, China.
- 19Zhengzhou Central Hospital, Zhengzhou, China.
- 20The Fourth People's Hospital of Chenzhou, Chenzhou, China.
- 21Hebei University of Engineering Affiliated Hospital, Handan, China.
- 22Henan Provincial Traditional Chinese Medicine Hospital, Zhengzhou, China.
- 23Yibin Second People's Hospital, Yibin, China.
- 24Julu County Hospital, Xingtai, China.
- 25Huainan Oriental Hospital Group Cancer Hospital, Huainan, China.
- 26Pengzhou People's Hospital, Pengzhou, China.
- 27Hebei Provincial Chest Hospital, Shijiazhuang, China.
- 28Yiyang Central Hospital, Yiyang, China.
- 29Shanghai First People's Hospital, Shanghai, China.
- 30Shanghai Sixth People's Hospital, Shanghai, China.
Abstract
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. 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). 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. 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.
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BibTeX
@article{cheng2026effects,
title = {{Effects of leritrelvir for adults with mild-to-moderate coronavirus disease 2019: a multicenter real-world study.}},
author = {Lin-Ling Cheng and Ming-Qing Lu and Bang-Han Ding and Hui-Qing Zeng and Tian-Xin Xiang and Wei-Dong Weng and Xu-Jing Liang and Jie Jin and Zi-Hao Liu and Hai-Ping Dong and Hui-Lin Wang and Chen-Li Xie and Run-Qi Luo and Xue-Bing Rong and Li-Li Yue and Jun-Rui Li and Feng Li and Yu-Ping Wei and San-Jing Li and Chao Xu and Chi-Guan Li and Hong-Yan Yu and Fei Wei and Wen-Quan Li and Hui-Feng Wang and Chuan-Liu Yang and Bang-Qiong Weng and Liang Wang and De-Qiang Wang and Peng-Yu Zhang and Zheng-Hao Tang and Zi-Feng Yang and Jian-Xing He and Nan-Shan Zhong},
journal = {Journal of thoracic disease},
year = {2026},
month = oct,
doi = {10.21037/jtd-2026-2569},
url = {https://europepmc.org/article/MED/42996986},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Effects of leritrelvir for adults with mild-to-moderate coronavirus disease 2019: a multicenter real-world study.
AU - Lin-Ling Cheng
AU - Ming-Qing Lu
AU - Bang-Han Ding
AU - Hui-Qing Zeng
AU - Tian-Xin Xiang
AU - Wei-Dong Weng
AU - Xu-Jing Liang
AU - Jie Jin
AU - Zi-Hao Liu
AU - Hai-Ping Dong
AU - Hui-Lin Wang
AU - Chen-Li Xie
AU - Run-Qi Luo
AU - Xue-Bing Rong
AU - Li-Li Yue
AU - Jun-Rui Li
AU - Feng Li
AU - Yu-Ping Wei
AU - San-Jing Li
AU - Chao Xu
AU - Chi-Guan Li
AU - Hong-Yan Yu
AU - Fei Wei
AU - Wen-Quan Li
AU - Hui-Feng Wang
AU - Chuan-Liu Yang
AU - Bang-Qiong Weng
AU - Liang Wang
AU - De-Qiang Wang
AU - Peng-Yu Zhang
AU - Zheng-Hao Tang
AU - Zi-Feng Yang
AU - Jian-Xing He
AU - Nan-Shan Zhong
PY - 2026
DA - 2026/10/27
JO - Journal of thoracic disease
DO - 10.21037/jtd-2026-2569
UR - https://europepmc.org/article/MED/42996986
AB - 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. 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). 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. 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.
SN - 2072-1439
SN - 2077-6624
ER -