The Efficacy and Safety of Ta1 for Sepsis

What Was Tested

In this phase 3 trial, researchers set out to test Thymosin Alpha-1.

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

The registry classes the interventions as drug and other.

More on the Plan

Therefore, the researchers intend to verify this finding through a randomized, double-blind and placebo-controlled clinical trial and the trail will include subjects with impaired immunologic functions.

Who Took Part

The registry lists 1106 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age ≥ 18 and ≤85;. Signed informed consent signed;. Infected focus are confirmed or suspected and satisfy at least one of the followings:. Pathogenic microbes grow in blood or at aseptic locations. Presence of abscess or partially-infected tissues.

The full record lists 11 inclusion and 12 exclusion criteria; among the exclusions: history of organ or bone marrow transplantation;; acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis;; under pregnancy or in suckling period;.

How the Study Was Run

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

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Thymosin Alpha-1.

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

It started in 2016-09-06 with completion listed for 2021-01-22.

It ran at 22 sites in China (22).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 28-day all-cause mortality (time frame: 28 days).

It also tracked 15 secondary outcomes, for example Incidence of new onset infection within 28 days, 28-day clearance rate of pathogenic microorganism, ICU stays, Hospital stays, 28-day re-hospitalization rate and Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Thymosin Alpha-1 in 1106 people.

With 1106 participants it is a large trial for this field.

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.