Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

What Was Tested

The trial (phase 4) is built around Thymosin Alpha-1.

It had two arms (groups): thymosin alpha 1 (experimental) and Placebo (placebo comparator).

Subcutaneous injections of placebo (saline) twice per day for seven days.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 20 actual participants took part.

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.

Examples of who could join: Written informed consent from the patients or their next of kin for patients unable to consent. Age ≥18 yrs. Presence of sepsis/ septic shock according to sepsis 3.0.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: pregnant or lactation period; age \<18 yrs; receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Thymosin Alpha-1 and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Thymosin Alpha-1 study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-03-31 with completion listed for 2016-09-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Maximum observed serum concentration (Cmax) of Ta 1, Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1, Terminal serum half-life (T-HALF) of Ta 1 and Time of maximum observed serum concentration (Tmax) of Ta 1.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Thymosin Alpha-1 in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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