Human evidence record · Thymosin alpha-1
TESTS Phase III thymosin alpha-1 sepsis trial
Mortality was 23.4% versus 24.1% (HR≈0.99; P=.93): no mortality benefit.
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Human evidence record
What this study tells us
Participants were assigned to groups by chance, which helps reduce selection bias. The exact comparator, blinding, population and endpoint still matter when judging the result.
Who was studied?
Adults with sepsis
How many?
n=1106
What happened?
Mortality was 23.4% versus 24.1% (HR≈0.99; P=.93): no mortality benefit.
What stops us overclaiming?
Large negative trial should temper conclusions from smaller/older heterogeneous studies and meta-analyses.
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Key result
Mortality was 23.4% versus 24.1% (HR≈0.99; P=.93): no mortality benefit.
Study details
Study designRandomized multicenter controlled trial
PhasePhase III
PopulationAdults with sepsis
Sample size1106
RouteSubcutaneous
Regimen / exposureEvery 12 hours for 7 days; abstract does not provide per-dose amount
Duration7 days
ComparatorControl
Primary endpoint / question28-day all-cause mortality
Safety resultNo major significant difference in secondary/safety outcomes reported in abstract.
Key limitationsLarge negative trial should temper conclusions from smaller/older heterogeneous studies and meta-analyses.
Registry / identifierPMID 39814420