The Efficacy and Safety of Thymosin Alpha1 for Sepsis (TESTS)
Study Overview
This study aimed to see if thymosin α1 can lower death rates in adults with sepsis.
Study Design
This was a phase 3 trial conducted at 22 centers in China from September 2016 to December 2020. It was double-blinded and placebo-controlled.
Participants
A total of 1106 adults aged 18-85 with sepsis were involved. They were randomly assigned to receive either thymosin α1 (552 participants) or a placebo (554 participants).
Intervention
Participants received a subcutaneous injection of thymosin α1 or placebo every 12 hours for seven days, unless they were discharged, passed away, or withdrew consent.
Main Outcome Measure
The main goal was to assess the death rate within 28 days after randomization. The analysis included participants who received at least one dose of the study drug.
Results
Out of 1106 participants, 1089 were analyzed. In the thymosin α1 group, 127 participants (23.4%) died, compared to 132 participants (24.1%) in the placebo group. The difference was not statistically significant.
Further analysis suggested that thymosin α1 may have different effects based on age and diabetes status.
Conclusions
The trial did not provide clear evidence that thymosin α1 reduces the 28-day death rate in adults with sepsis.
Trial Registration
ClinicalTrials.gov NCT02867267.
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