Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection

What Was Tested

In this phase 2 trial, researchers set out to test Thymosin Alpha-1.

Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.

It had two arms (groups): Ta1 treatment arm (experimental) and Control arm (no intervention).

No treatment will be provided in addition to standard of care.

The registry classes the interventions as drug.

More on the Plan

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.

ZADAXIN® brand Ta1 is a synthetic version currently approved for use in 37 countries; in particular it is approved in China for treatment of hepatitis B and to enhance vaccine response.

Notably, Ta1 has been used clinically in pilot studies for treatment of severe acute respiratory syndrome (SARS) and other lung infections including acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disorder (COPD), as well as infections after bone marrow transplant.

Ta1 restores immune system homeostasis, by acting as multi-tasking protein depending on the host state of inflammation or immune dysfunction (such as infectious disease and cancer).

Who Took Part

The registry lists 56 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: Signed informed consent. PCR positive for COVID-19 within the last 4 days. Lymphopenia (total lymphocyte count \< 1.5 × 109/L).

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: patients on mechanical ventilation; patients who are pregnant or breastfeeding; patients with multi-organ failure.

How the Study Was Run

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

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

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

Everyone knew when Thymosin Alpha-1 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-09-10 with completion listed for 2023-02-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to recovery (free of respiratory failure) (time frame: Day 28).

It also tracked 14 secondary outcomes, for example Lymphopenia, Survival, Requirement for high flow oxygen supplementation, Duration of high flow oxygen supplementation, ICU admission and ICU length of stay.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 56 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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