TESTS
Trial question
What is the effect of thymosin α₁ in patients with sepsis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 1089
1089 patients (339 female, 750 male).
Inclusion criteria: adult patients aged 18-85 years with sepsis.
Key exclusion criteria: pregnancy or lactation; hematological malignancies; organ or bone marrow transplantation; acute phase autoimmune disease or glomerulonephritis; allergy or intolerance to thymosin α₁; CPR within 72 hours of signing consent form; incomplete neurological recovery.
Interventions
N=542 thymosin α₁ (subcutaneous injection of 1.6 mg lyophilized thymosin α₁ every 12 hours for 7 days).
N=547 placebo (subcutaneous injection of lyophilized saline every 12 hours for 7 days).
Primary outcome
Death at day 28
23.4%
24.1%
24.1 %
18.1 %
12.1 %
6.0 %
0.0 %
Thymosin
α1
Placebo
No significant
difference ↔
No significant difference in death at day 28 (23.4% vs. 24.1%; HR 0.99, 99% CI 0.77 to 1.27).
Secondary outcomes
No significant difference in death at day 90 (31% vs. 32.4%; HR 0.94, 95% CI 0.76 to 1.16).
No significant difference in new-onset infection at day 28 (25.3% vs. 26.1%; ARD -0.9, 95% CI -6.1 to 4.3).
No significant difference in pathogenic microorganism clearance rate at day 28 (20.3% vs. 16.3%; AD 4%, 95% CI -0.9 to 9).
Safety outcomes
No significant difference in adverse and serious adverse events at day 90.
Conclusion
In adult patients aged 18-85 years with sepsis, thymosin α₁ was not superior to placebo with respect to death at day 28.
Reference
Jianfeng Wu, Fei Pei, Lixin Zhou et al. The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025 Jan 15:388:e082583.
Open reference URL