A Phase 4 interventional study of Thymalfasin in Sepsis and Septic Shock, sponsored by Southeast University, China. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Southeast University, China · Phase 4, Interventional, and Treatment
This prospective, single-arm study will evaluate whether thymosin alpha 1 treatment affects serum immunoglobulin M (IgM) levels in adults with sepsis. Participants will receive standard care plus thymosin alpha 1 1.6 mg by subcutaneous injection every 12 hours for 5 days. Blood samples will be collected before treatment and on days 1, 3, 5, and 7 to measure IgM and plasma microvesicles. The study aims to clarify whether thymosin alpha 1 may support early immune responses in sepsis.
Sepsis is a life-threatening syndrome caused by a dysregulated response to infection. Immunoglobulin M (IgM) is an important early antibody involved in pathogen clearance, and low IgM levels have been associated with impaired pathogen clearance and worse outcomes in severe infection. Thymosin alpha 1 is a synthetic immunomodulatory peptide used in clinical practice. This study will explore whether exogenous thymosin alpha 1 supplementation affects serum IgM levels in adults with sepsis.
This is a prospective, single-arm, exploratory study at the Department of Critical Care Medicine, Zhongda Hospital Southeast University. Approximately 36 adults aged 18 to 85 years with sepsis diagnosed according to Sepsis-3.0 will be enrolled. In addition to standard clinical care, participants will receive thymosin alpha 1 1.6 mg subcutaneously within 6 hours after ICU admission, followed by 1.6 mg every 12 hours for 5 days. Blood samples will be collected before treatment and on days 1, 3, 5, and 7 to measure serum IgM by ELISA and plasma microvesicles by flow cytometry.
Clinical data will include demographic and baseline characteristics, routine laboratory tests, organ dysfunction scores, adverse events, and outcomes including 28-day mortality, ICU mortality, and hospital mortality. No randomization or placebo control is planned.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 36 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Southeast University, China is the lead sponsor of 168 studies on the registry; 45 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with sepsis receiving standard clinical care plus thymosin alpha 1 1.6 mg subcutaneously every 12 hours for 5 days.
Drug: Thymalfasin
Thymosin alpha 1 1.6 mg administered subcutaneously within 6 hours after ICU admission, then every 12 hours for 5 days, in addition to standard clinical care for sepsis.
Also known as: Thymosin alpha 1, Zadaxin
Serum IgM Concentration
Serum IgM concentration measured by enzyme-linked immunosorbent assay (ELISA) before treatment and on days 1, 3, 5, and 7 after treatment.
Time frame: Baseline and days 1, 3, 5, and 7 after treatment
Plasma T-Cell-Derived Microvesicle Count
Number of T-cell-derived microvesicles in plasma measured by flow cytometry after differential centrifugation.
Time frame: Baseline and days 1, 3, 5, and 7 after treatment
28-Day All-Cause Mortality
Proportion of participants who die from any cause within 28 days after enrollment.
Time frame: From enrollment to 28 days after enrollment
ICU Mortality
Proportion of participants who die during the intensive care unit stay, assessed up to 28 days after enrollment.
Time frame: From enrollment to 28 days after enrollment
Hospital Mortality
Proportion of participants who die during the hospital stay, assessed up to 28 days after enrollment.
Time frame: From enrollment to 28 days after enrollment
Organ Dysfunction Scores
Organ dysfunction scores recorded during the study, including the Sequential Organ Failure Assessment (SOFA) score.
Time frame: During the 5-day treatment period
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jan 2027, 11 months after the start.
Of 39 non-industry phase 4 interventional studies under Shock, Septic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 38. This study's planned 11 months is below that.
Counting every sponsor, half of 40 studies reached it within 24 months; a quarter within 16 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thymalfasin