PMID-39814420 – TESTS Phase 3 Trial: Thymosin Alpha-1 for Sepsis
Wu J et al. "The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial," BMJ, 2025;388:e082583. doi:10.1136/bmj-2024-082583
Quick Reference
| Property | Value |
|---|---|
| PMID | 39814420 |
| DOI | 10.1136/bmj-2024-082583 |
| Year | 2025 |
| Journal | BMJ |
| Study Type | RCT |
| Evidence Level | I |
| Sample | n=1,089 adults with sepsis across 22 centers in China |
| Peptide(s) Studied | Thymosin Alpha-1 |
Key Findings
- Primary endpoint NEGATIVE: Thymosin α1 did NOT reduce 28-day all-cause mortality vs. placebo (23.4% vs. 24.1%)
- No significant differences in secondary endpoints including ICU length of stay
- Subgroup analyses suggested possible differential effects by age and diabetes status
- Safety profile comparable to placebo — no additional safety concerns identified
- Largest and most rigorous RCT of thymosin alpha-1 for sepsis ever conducted
Study Design
Multicenter, double-blind, randomized, placebo-controlled Phase 3 trial across 22 centers in China. 1,089 adults with sepsis randomized to thymosin α1 or placebo. Primary outcome: 28-day all-cause mortality. Pre-specified subgroup analyses included.
Limitations
- Conducted exclusively in China; generalizability to other populations uncertain
- Sepsis patient population may be heterogeneous; benefits in specific subgroups cannot be ruled out
- Single regimen tested; alternative dosing strategies not explored
Clinical Relevance
This is the definitive negative trial for thymosin alpha-1 in sepsis, published in the BMJ (top-tier journal). It contrasts with earlier positive meta-analyses (PMID-26517783) and necessitates an honest reassessment of the sepsis evidence. However, the clean safety profile and possible subgroup effects keep the door open for targeted use. Critical for an evidence-balanced vault entry.
Related
#research #RCT #evidence-level-I