Effects of Lianhuaqingwen Capsules in adults with mild-to-moderate coronavirus disease 2019: an international, multicenter, double-blind, randomized controlled trial
Jin-Ping Zheng, Yun Ling, Liang-Shuang Jiang, Piroon Mootsikapun, Hong-Zhou Lu, Methee Chayakulkeeree, Li-Xiu Zhang, Pureepat Arttawejkul, Feng-Yu Hu, Thi Ngoc Lan Truong, Roxan A Perez, Xing Gu, Hui-Min Sun, Jian-Jie Jiang, Ren-Jie Liu, Zhen Ding, Yang-Qing Zhan, Zi-Feng Yang, Wei-Jie Guan, Nan-Shan Zhong
Virology Journal, doi:10.1186/s12985-023-02144-6
Background In a randomized trial, Lianhuaqingwen (LHQW) capsule was effective for accelerating symptom recovery among patients with coronavirus disease 2019 (COVID-19). However, the lack of blinding and limited sample sizes decreased the level of clinical evidence. Objectives To evaluate the efficacy and safety of LHQW capsule in adults with mild-to-moderate COVID-19.
Methods We conducted a double-blind randomized controlled trial in adults with mild-to-moderate COVID-19 (17 sites from China, Thailand, Philippine and Vietnam). Patients received standard-of-care alone or plus LHQW capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the median time to sustained clinical improvement or resolution of nine major symptoms.
Results The full-analysis set consisted of 410 patients in LHQW capsules and 405 in placebo group. LHQW significantly shortened the primary endpoint in the full-analysis set (4.0 vs. 6.7 days, hazards ratio: 1.63, 95% confidence interval: 1.39-1.90). LHQW capsules shortened the median time to sustained clinical improvement or resolution of stuffy or runny nose (2.8 vs. 3.7 days), sore throat (2.0 vs. 2.6 days), cough (3.2 vs. 4.9 days), feeling hot or feverish (1.0 vs. 1.3 days), low energy or tiredness (1.3 vs. 1.9 days), and myalgia (1.5 vs. 2.0 days). The duration to sustained clinical improvement or resolution of shortness of breath, headache, and chills or shivering did not differ significantly between the two groups. Safety was comparable between the two groups. No serious adverse events were reported.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s12985-023-02144-6. Additional file 1: Online supplementary tables and figures. Author contributions J. P. Z., Z. F. Y. and N. S. Z. participated in study design; Y. L., L. S. J., P. M., H. Z. L., M. C., L. X. Z., P. A., F. Y. H., T. T. N. L., R. A. P., X. G., H. M. S., J. J. J., R. J. L., Z. D. and Y. Q. Z. recruited patients and performed follow up; W. J. G., J. P. Z. and N. S. Z. drafted the manuscript; J. P. Z. and N. S. Z. were responsible for study conception and provided critical review of the manuscript. All authors read and approved the final manuscript. J. P. Z. and N. S. Z. were the guarantors of the study.
Declarations Ethics approval and consent to participate Ethics approval has been obtained the ethics committee of each participating site, based on Good Clinical Practice. All patients signed written informed consent.
Competing interests None.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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