The Efficacy and Safety of Ta1 for Sepsis

Summary

The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis

Timeline

Start

2016-09-06

Primary completion

2021-01-22

Completion

2021-03-23

Outcome

Missed primary endpoint

paper hazard ratio 0.99, 95% confidence interval 0.77 to 1.27; P=0.93 with log-rank test PMID 39814420 ↗

Publications

• Results Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
• Results Romani L, Bistoni F, Montagnoli C, Gaziano R, Bozza S, Bonifazi P, Zelante T, Moretti S, Rasi G, Garaci E, Puccetti P. Thymosin alpha1: an endogenous regulator of inflammation, immunity, and tolerance. Ann N Y Acad Sci. 2007 Sep;1112:326-38. doi: 10.1196/annals.1415.002. Epub 2007 May 10.
• Results Romani L, Moretti S, Fallarino F, Bozza S, Ruggeri L, Casagrande A, Aversa F, Bistoni F, Velardi A, Garaci E. Jack of all trades: thymosin alpha1 and its pleiotropy. Ann N Y Acad Sci. 2012 Oct;1269:1-6. doi: 10.1111/j.1749-6632.2012.06716.x.
• Results Wang X, Li W, Niu C, Pan L, Li N, Li J. Thymosin alpha 1 is associated with improved cellular immunity and reduced infection rate in severe acute pancreatitis patients in a double-blind randomized control study. Inflammation. 2011 Jun;34(3):198-202. doi: 10.1007/s10753-010-9224-1.
• Pei F, Gu B, Liu Z, Li G, Nie Y, Chen M, Liu Y, Guan X, Chen Q, Wu J. Validation of SOFA-2 score in sepsis and exploration of its extension with additional immune markers. J Intensive Med. 2026 Jan 8;6(3):294-301. doi: 10.1016/j.jointm.2025.12.003. eCollection 2026 Jun.
• Wu J, Pei F, Zhou L, Li W, Sun R, Li Y, Wang Z, He Z, Zhang X, Jin X, Long Y, Cui W, Wang C, Chen E, Zeng J, Yan J, Lin Q, Zhou F, Huang L, Shang Y, Duan M, Zheng W, Zhu D, Kou Q, Zhang S, Liu Y, Yao C, Shang M, Peng S, Zhou Q, Cheng KK, Guan X; TESTS study collaborator group. The efficacy and safety of thymosin alpha1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025 Jan 15;388:e082583. doi: 10.1136/bmj-2024-082583.

Drugs

Indications