The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial

• Published in: BMJ (Online) 2025-01, Vol.388, p.e082583
• Main Authors: Wu, Jianfeng, Pei, Fei, Zhou, Lixin, Li, Weiqin, Sun, Renhua, Li, Yimin, Wang, Zheng, He, Zhijie, Zhang, Xiaofei, Jin, Xiaodong, Long, Yun, Cui, Wei, Wang, Chunting, Chen, Erzhen, Zeng, Jun, Yan, Jing, Lin, Qinhan, Zhou, Feihu, Huang, Lei, Shang, You, Duan, Meili, Zheng, Wei, Zhu, Duming, Kou, Qiuye, Zhang, Shihong, Liu, Yin, Yao, Chen, Shang, Meixia, Peng, Sui, Zhou, Qian, Cheng, Kar Keung, Guan, Xiangdong, Ouyang, Bin, Cai, Changjie, Chen, Minying, Liu, Yongjun, Liu, Zimeng, Wang, Cuiping, Nie, Yao, Liu, Yihao, Li, Bin, Qiang, Xinhua, Wang, Fengyun, Xiao, Ping, Lin, Wei, Ke, Lu, Zhou, Jing, Yang, Qi, Mao, Wenjian, Liu, Jingquan, Gong, Fangxiao, Qiu, Liannv, Liu, Xiaoqing, Li, Runhua, Di, Ying, Gao, Jie, Li, Weichao, Zou, Zijun, Shi, Yiming, Chen, Yao, Hu, Chenggong, Yan, Lin, Feng, Weihua, Du, Linlin, Huang, Tiancha, Chi, Yi, Ding, Wenyan, Huang, Chunmei, Wu, Wei, Zhang, Jicheng, Tai, Zijian, Liu, Yan, Chen, Ying, Yang, Zhitao, Lu, Jing, Wu, Xiaoqin, Su, Wei, Xu, Liang, Shen, Yanfei, Luo, Gang, Wu, Weiliang, Hu, Xin, Mao, Zhi, Lin, Yingxin, Zhang, Weixing, Xu, Jiqian, Zou, Xiaojing, Zhi, Deyuan, Zhou, Xiao, Wang, Wei, Zhong, Jiwen, Zhong, Ming, Xuan, Lizhen
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular disease; Chemotherapy; China - epidemiology; Chronic illnesses; Clinical trials; COVID-19; Diabetes mellitus; Double-Blind Method; Drug development; Drug dosages; Female; Humans; Immune system; Immunomodulation; Immunomodulators; Injections, Subcutaneous; Lymphocytes; Male; Microorganisms; Middle Aged; Mortality; Patients; Placebos; Sepsis; Sepsis - drug therapy; Sepsis - mortality; Statistical analysis; Thymalfasin - therapeutic use; Thymosin - adverse effects; Thymosin - analogs & derivatives; Thymosin - therapeutic use; Treatment Outcome; Young Adult
• ISSN: 1756-1833; 1756-1833
• DOI: 10.1136/bmj-2024-082583

AbstractObjectiveTo evaluate whether the immunomodulatory drug thymosin α1 reduces mortality in adults with sepsis.DesignMulticentre, double blinded, placebo controlled phase 3 trial.Setting22 centres in China, September 2016 to December 2020.Participants1106 adults aged 18-85 years with a diagnosis of sepsis according to sepsis-3 criteria and randomly assigned in a 1:1 ratio to receive thymosin α1 (n=552) or placebo (n=554). A stratified block method was used for randomisation, and participants were stratified by age (