The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial.

ABSTRACT:

Objective

To evaluate whether the immunomodulatory drug thymosin α1 reduces mortality in adults with sepsis.

Design

Multicentre, double blinded, placebo controlled phase 3 trial.

Setting

22 centres in China, September 2016 to December 2020.

Participants

1106 adults aged 18-85 years with a diagnosis of sepsis according to sepsis-3 criteria and randomly assigned in a 1:1 ratio to receive thymosin α1 (n=552) or placebo (n=554). A stratified block method was used for randomisation, and participants were stratified by age (<60 and ≥60 years) and centre.

Interventions

Subcutaneous injection of thymosin α1 or placebo every 12 hours for seven days unless discontinued owing to discharge from the intensive care unit, death, or withdrawal of consent.

Main outcom

SUBMITTER: Wu J 

PROVIDER: S-EPMC11780596 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature