Skip to content

Study · Randomized controlled trial · n = 361 · 2013

4 results

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

Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B and 7 more

Show all authors

Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X

Critical care (London, England)17 Jan 2013Cited by 105 (Europe PMC)

PMID23327199 (opens in a new tab)PMCIDPMC4056079 (opens in a new tab)DOI10.1186/cc11932 (opens in a new tab)PepBankPUB-23327199
Download PDFPubMedAsk about this study
Jump to 4 results

Summary

IntroductionSevere sepsis is associated with a high mortality rate despite implementation of guideline recommendations. Adjunctive treatment may be efficient and require further investigation. In light of the crucial role of immunologic derangement in severe sepsis, thymosin alpha 1 (Tα1) is considered as a promising beneficial immunomodulatory drug. The trial is to evaluate whether Tα1 improves 28-day all-cause mortality rates and immunofunction in patients with severe sepsis.MethodsWe performed a multicenter randomized controlled trial in six tertiary, teaching hospitals in China between May 12, 2008 and Dec 22, 2010. Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio). The primary outcome was death from any cause and was assessed 28 days after enrollment. Secondary outcomes included dynamic changes of Sequential Organ Failure Assessment (SOFA) and monocyte human leukocyte antigen-DR (mHLA-DR) on day 0, 3, 7 in both groups. All analyses were done on an intention-to-treat basis.ResultsA total of 361 patients were allocated to either the control group (n = 180) or Tα1 (n = 181) group. The mortalities from any cause within 28 days in the Tα1 group and control group were 26.0% and 35.0% respectively with a marginal P value (nonstratified analysis, P = 0.062; log rank, P = 0.049); the relative risk of death in the Tα1 group as compared to the control group was 0.74 (95% CI 0.54 to 1.02). Greater improvement of mHLA-DR was observed in the Tα1 group on day 3 (mean difference in mHLA-DR changes between the two groups was 3.9%, 95% CI 0.2 to 7.6%, P = 0.037) and day 7 (mean difference in mHLA-DR changes between the two groups was 5.8%, 95% CI 1.0 to 10.5%, P = 0.017) than in the control group. No serious drug-related adverse event was recorded.ConclusionsThe use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis.Trial registrationClinicalTrials.gov NCT00711620.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In ICU patients with severe sepsis, 28-day mortality was 26.0% with thymosin alpha‑1 and 35.0% with control, a marginally significant difference.

    In plain wordsIn ICU patients with severe sepsis, fewer died within 28 days with thymosin alpha‑1 than with control, but the difference was borderline.

    Peptide
    Thymosin alpha-1
    Outcome
    Decrease28-day all-cause mortality
    Study

    n = 361

    Comparator
    Control group
    Analysis
    Primary
    Outcome group
    Mortality · Infection
    Studied dose
    Dose not stated

    Measurements

    28-day mortality
    26%
    thymosin alpha 1
    28-day mortality
    35%
    control
    Relative risk of death
    0.74 RR
    thymosin alpha 1 versus control

    Source sentences

    Summary
    The mortalities from any cause within 28 days in the Tα1 group and control group were 26.0% and 35.0% respectively with a marginal P value (nonstratified analysis, P = 0.062; log rank, P = 0.049); the relative risk of death in the Tα1 group as compared to the control group was 0.74 (95% CI 0.54 to 1.02).
    1 context sentence
    Summary · context
    Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In ICU patients with severe sepsis, monocyte HLA-DR improved more with thymosin alpha‑1 than with control on day 3.

    In plain wordsIn ICU patients with severe sepsis, a marker of immune function (monocyte HLA-DR) improved more with thymosin alpha‑1 than with control on day 3.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreasemHLA-DR change at day 3
    Study

    n = 361

    Comparator
    Control group
    Analysis
    Secondary
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    Mean difference in mHLA-DR change
    3.9%
    day 3

    Source sentences

    Summary
    Greater improvement of mHLA-DR was observed in the Tα1 group on day 3 (mean difference in mHLA-DR changes between the two groups was 3.9%, 95% CI 0.2 to 7.6%, P = 0.037)
    1 context sentence
    Summary · context
    Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In ICU patients with severe sepsis, monocyte HLA-DR improved more with thymosin alpha‑1 than with control on day 7.

    In plain wordsIn ICU patients with severe sepsis, a marker of immune function (monocyte HLA-DR) improved more with thymosin alpha‑1 than with control on day 7.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreasemHLA-DR change at day 7
    Study

    n = 361

    Comparator
    Control group
    Analysis
    Secondary
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    Mean difference in mHLA-DR change
    5.8%
    day 7

    Source sentences

    Summary
    Greater improvement of mHLA-DR was observed in the Tα1 group on day 3 (mean difference in mHLA-DR changes between the two groups was 3.9%, 95% CI 0.2 to 7.6%, P = 0.037) and day 7 (mean difference in mHLA-DR changes between the two groups was 5.8%, 95% CI 1.0 to 10.5%, P = 0.017) than in the control group.
    1 context sentence
    Summary · context
    Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio).
  4. 04HumanRandomized controlled trialSafety outcome

    In ICU patients with severe sepsis, no serious drug-related adverse event was recorded with thymosin alpha‑1.

    In plain wordsIn ICU patients with severe sepsis, no serious side effect linked to thymosin alpha‑1 was recorded.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeSerious drug-related adverse events
    Study

    n = 361

    Comparator
    Control group
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    No serious drug-related adverse event was recorded.
    1 context sentence
    Summary · context
    Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials5

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

5 trials · 4 completed · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 4NCT06178146

Thymosin Alpha-1 for irAE Secondary to ICIs

Jun Wangn = 401 Sept 2023 to est. Apr 2025

IrAE

Trial pageClinicalTrials.govUpdated 20 Dec 2023
CompletedPhase 2NCT06139419

The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC

Sun Yat-sen Universityn = 11425 Jul 2023 to 30 Jun 2026

Non-small Cell Lung Cancer

Trial pageClinicalTrials.govUpdated 3 Aug 2026
CompletedPhase 2NCT03659578

Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Sun Yat-sen Universityn = 699 Aug 2018 to 30 Sept 2021

Non-small Cell Lung Cancer

Trial pageClinicalTrials.govUpdated 3 Jan 2022
CompletedPhase 3NCT02867267

The Efficacy and Safety of Ta1 for Sepsis

Sun Yat-sen Universityn = 1,1066 Sept 2016 to 23 Mar 2021

Sepsis

Trial pageClinicalTrials.govUpdated 10 Apr 2023
CompletedNot applicableNCT00711620

Efficacy of Thymosin alpha1 for Severe Sepsis

Sun Yat-sen Universityn = 366May 2008 to Jan 2011

Severe Sepsis

Trial pageClinicalTrials.govUpdated 14 Jun 2011

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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