Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients

What Was Tested

The trial (phase 2) is built around Thymosin Alpha-1.

It had two arms (groups): Active arm (experimental) and Control arm (no intervention).

Standard care.

The registry classes the interventions as drug.

More on the Plan

Thymalfasin (thymosin alpha 1, Ta1) is a naturally occurring peptide that has been evaluated for its immunomodulatory activities and related therapeutic potential in several conditions and diseases, including infectious disease and cancer.

The study will also evaluate the need for hospitalization in those patients who do not become infected with COVID-19.

Who Took Part

Enrollment: 189 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: Age 18 or greater. Signed informed consent. End-stage renal disease (ESRD) who receive hemodialysis 2 or more times each week and are expected to continue on dialysis indefinitely.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: patients for whom renal transplantation is anticipated within the next six months; patients with an anticipated survival of less than 3 months; patients with symptoms that might be attributable to covid-19 infection.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Being open-label, the Thymosin Alpha-1 study did not mask who received what.

It started in 2021-01-12 with completion listed for 2023-01-19.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Number of Participants With COVID-19 Infection (time frame: 6 months).

It also tracked 3 secondary outcomes, for example Hospitalization, Non-COVID-19 Infections and Mortality.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 189 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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