Skip to content

Trial · Interventional

CompletedPhase 3Registry data

The Efficacy and Safety of Ta1 for Sepsis

Short name TESTS

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,106 participants (actual)
Sponsor
Sun Yat-sen University · Other
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
6 Sept 2016
Primary completion
22 Jan 2021
Completion
23 Mar 2021
First posted
15 Aug 2016 (estimated)
Last update posted
10 Apr 2023
Conditions
Sepsis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019202020212022
  1. Ph 3

    TESTS

    NCT02867267

    6 Sept 2016 to 23 Mar 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis

Interventions

  • Thymosin alpha 1Drug
  • PlaceboOther

Arms2

  • Experimental

    thymosin alpha 1

    1ml subcutaneous injection with 1.6 mg thymosin alpha 1, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition

  • Placebo comparator

    Placebo

    1ml subcutaneous injection with placebo, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 28-day all-cause mortality

    Time frame · 28 days

Secondary outcomes(15)
  1. Incidence of new onset infection within 28 days

    Time frame · 28 days

    Registry description

    from initial injection on day 0 to day 28

  2. 28-day clearance rate of pathogenic microorganism

    Time frame · 28 days

  3. ICU stays

    Time frame · 90 days

  4. Hospital stays

    Time frame · 28 days

  5. 28-day re-hospitalization rate

    Time frame · 28 days

  6. Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28

    Time frame · 28 days

  7. 90-day all-cause mortality

    Time frame · 90 days

  8. ICU mortality

    Time frame · 90 days

  9. Ventilator-free days within 28 days

    Time frame · 28 days

  10. ICU-free days within 28 days

    Time frame · 28 days

  11. CRRT-free days within 28 days

    Time frame · 28 days

  12. Vasoactive agents-free days within 28 days

    Time frame · 28 days

  13. 90-day SF-36 QOL scale

    Time frame · 90 days

  14. Variance of the count of monocyte human lymphocyte antigens-DR (mHLA-DR) at days 7, 14 and 28 compared with the baseline at screening

    Time frame · 28 days

  15. The percentage of Treg cells at screening and days 7

    Time frame · 7 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

4 results

The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial.

Wu et al. 2013Critical care (London, England)cited by 105

PMID 23327199PMC4056079DOI 10.1186/cc11932PUB-23327199

CC BY4 results

Indexing hint: Review · 2012

Jack of all trades: thymosin α1 and its pleiotropy.

Romani et al. 2012Annals of the New York Academy of Sciencescited by 48

PMID 23045964DOI 10.1111/j.1749-6632.2012.06716.xPUB-23045964

Full text at the publisher
Publisher page

Indexing hint: Review · 2007

Thymosin alpha1: an endogenous regulator of inflammation, immunity, and tolerance.

Romani et al. 2007Annals of the New York Academy of Sciencescited by 82

PMID 17495242DOI 10.1196/annals.1415.002PUB-17495242

Full text at the publisher
Publisher page

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2025

Corrected

The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial.

Wu et al. 2025BMJ (Clinical research ed.)cited by 24

PMID 39814420PMC11780596DOI 10.1136/bmj-2024-082583PUB-39814420

Free to read · publisher termsCC BY-NC

Indexing hint: Randomized controlled trial · 2011

Corrected

Thymosin alpha 1 is associated with improved cellular immunity and reduced infection rate in severe acute pancreatitis patients in a double-blind randomized control study.

Wang et al. 2011Inflammationcited by 17

PMID 20549321DOI 10.1007/s10753-010-9224-1PUB-20549321

Full text at the publisher

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPei F, Gu B, Liu Z, Li G, Nie Y, Chen M, Liu Y, Guan X, Chen Q, Wu J. Validation of SOFA-2 score in sepsis and exploration of its extension with additional immune markers. J Intensive Med. 2026 Jan 8;6(3):294-301. doi: 10.1016/j.jointm.2025.12.003. eCollection 2026 Jun. PMID 42164588

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Age ≥ 18 and ≤85; 2. Signed informed consent signed; 3. Diagnosed as a sepsis according to the sepsis diagnosis criteria in "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016": at least one acute severe organ dysfunction related to sepsis, and total SOFA scores ≥2; 4. Infected focus are confirmed or suspected and satisfy at least one of the followings: 1. pathogenic microbes grow in blood or at aseptic locations 2. presence of abscess or partially-infected tissues 3. suspected infection identified by at least one of the following evidences: * leukocytes at normal aseptic locations * organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage) * Imaging evidence of pneumonia accompanied by purulent secretion * Related syndromes with high infection risk (cholangitis for example) Exclusion Criteria: 1. History of organ or bone marrow transplantation; 2. Acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis; 3. Under pregnancy or in suckling period; 4. Presence of hematologic malignancies; 5. The patient has received radiotherapy or chemotherapy within the past 30 days; 6. The patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment; 7. The patient has in the past 30 days received immunosuppressive drugs (tripterygium wilfordii, CellCept, cyclophosphamide, FK506, etc.) or received continuous treatment with prednisolone \>10 mg/day (or the same dose of other hormones); 8. The patient could die of an underlying disease within 28 days or is in end-stage; 9. The patient has undergone CPR in the 72 hours before signing the informed consent and the neuromechanism has not fully recovered (GCS score ≤ 8); 10. The patient has in the past 30 days used thymosin or undergone certain clinical drug or instrument trials which could affect immunity (such as Xuebijing, ulinastatin and CRRT); 11. The patient has a medical history of allergy or intolerance to thymalfasin; 12. The source of infection cannot be contained, for example: infections that cannot be handled during surgical operations and drainage.

PepBank is a research reference. Talk to a doctor before you use any peptide.