Thymalfasin for Immune Recovery in Adults With Sepsis

What Was Tested

This registered not phased trial tested Thymosin Alpha-1.

Sepsis is a life-threatening illness caused by an abnormal response to infection.

It had two arms (groups): Thymalfasin Plus Standard Care (experimental) and Standard Care Alone (no intervention).

Participants will receive standard sepsis care determined by the treating clinicians, including infection source control, antimicrobial therapy, fluid resuscitation, vasopressors, and organ support as clinically indicated. No thymalfasin or placebo injections will be given as study interventions. Thirty participants are planned for this arm.

The registry classes the interventions as drug.

More on the Plan

This investigator-initiated, single-center, prospective, randomized, controlled exploratory study will evaluate thymalfasin in adults with sepsis and an immunosuppressed phenotype.

Eligible participants will meet Sepsis-3 criteria, have an Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 15 to 30 at ICU admission, and meet the protocol-defined monocyte HLA-DR eligibility criterion.

Enrollment must occur within 48 hours of sepsis onset.

Written informed consent will be obtained from the participant or a legally authorized representative.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: known allergy to thymalfasin or any of its excipients. a history of primary or acquired immunodeficiency, such as hiv infection or post-transplant immunosuppression.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Thymosin Alpha-1 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.

In this single-blind Thymosin Alpha-1 study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-10-06 with completion listed for 2028-05-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Monocyte HLA-DR Expression at Day 7 (time frame: Baseline (Day 0, before randomization) and Day 7).

It also tracked 17 secondary outcomes, for example Recovery Slope of Monocyte HLA-DR Expression Through Day 14, Recovery Slope of Absolute Lymphocyte Count Through Day 14, Change From Baseline in PD-1 Expression on CD8-Positive T Cells at Day 7, Absolute Natural Killer Cell Count at Baseline and Day 7, Mechanical Ventilation-Free Days Through Day 28 and Vasopressor-Free Days Through Day 28.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Thymosin Alpha-1 in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.