Human evidence record · Thymosin alpha-1

ETASS: thymosin alpha-1 for severe sepsis

Mortality was 26.0% versus 35.0%; RR 0.74 (95% CI 0.54-1.02), with borderline/mixed significance depending on analysis; mHLA-DR improved.

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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 severe sepsis

How many?

n=361

What happened?

Mortality was 26.0% versus 35.0%; RR 0.74 (95% CI 0.54-1.02), with borderline/mixed significance depending on analysis; mHLA-DR improved.

What stops us overclaiming?

Earlier smaller trial; mortality estimate crossed 1.0 and later larger TESTS trial was negative.

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Key result

Mortality was 26.0% versus 35.0%; RR 0.74 (95% CI 0.54-1.02), with borderline/mixed significance depending on analysis; mHLA-DR improved.

Study details

Study designMulticenter randomized controlled trial; single-blind

PopulationAdults with severe sepsis

Sample size361

RouteSubcutaneous

Regimen / exposureThymosin alpha-1 added to standard care; exact regimen per trial protocol

Duration28 days

ComparatorControl

Primary endpoint / question28-day all-cause mortality and immune markers

Safety resultNo definitive large-trial safety conclusion.

Key limitationsEarlier smaller trial; mortality estimate crossed 1.0 and later larger TESTS trial was negative.

Registry / identifierPMID 23327199

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