The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial
An erratum to this article was published (BMJ, 30 May 2025 ↗)
Primary resultResult — go to the resultHazard ratio 0.99 95% CI 0.77–1.27Authors' conclusion
This trial found no clear evidence to suggest that thymosin α1 decreases 28 day all cause mortality in adults with sepsis.
Study context
- Population
- Adults aged 18–85 years with sepsis (sepsis-3 criteria), 22 centres in China, September 2016 to December 20201,089 in modified ITT analyses
- Participants
- 1,106 adults
- Comparison
- Thymosin α1 vs placebo
- Thymosin α1n = 552
- Placebon = 554reference
- Primary endpoint
- All cause mortality after randomisation
- Follow-up
- 28 day
Methodological detailsmulticentre, double blinded, placebo controlled, phase 3, Stratified block randomisation 1:1 by age (<60 and ≥60 years) and centre
- Multicentre
- Double blinded
- Placebo controlled
- Phase 3
- Stratified block randomisation 1:1 by age (<60 and ≥60 years) and centre
Primary result
As reported in the abstract
Hazard ratio
0.99
95% CI 0.77–1.27
P = 0.93
Events by treatment group
Thymosin α1 vs Placebo
HR 0.99 (95% CI 0.77–1.27); P = 0.93
Further findings
| Outcome | HR (CI) | |
|---|---|---|
| 28 day all cause mortality by age (prespecified subgroup)Thymosin α1 vs Placebo · <60 years | 1.67 (1.04–2.67) | |
| 28 day all cause mortality by age (prespecified subgroup)Thymosin α1 vs Placebo · ≥60 years | 0.81 (0.61–1.09) | |
| 28 day all cause mortality by diabetes (prespecified subgroup)Thymosin α1 vs Placebo · diabetes | 0.58 (0.35–0.99) | |
| 28 day all cause mortality by diabetes (prespecified subgroup)Thymosin α1 vs Placebo · no diabetes | 1.16 (0.87–1.53) | |
| 0.20.5125Hazard ratio (log scale) |
- 28 day all cause mortality by age (prespecified subgroup): P for interaction=0.01
- 28 day all cause mortality by diabetes (prespecified subgroup): P for interaction=0.04
Secondary outcomes
- No secondary outcome differed statistically significantly between the two groups
Safety
- No safety outcome differed statistically significantly between the two groups
Original publication
The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. Published 15 January 2025. doi:10.
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