SepsisPhase 4NCT07922954
Thymosin Alpha 1 and IgM Levels in Sepsis
A Phase 4 study testing Thymalfasin in people with Sepsis and Septic Shock, run by Southeast University, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Thymalfasin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2026to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 85 years.
- Admitted to the Department of Critical Care Medicine, Zhongda Hospital Southeast University, with sepsis diagnosed according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3.0): confirmed or highly suspected infection with an acute increase in Sequential Organ Failure Assessment (SOFA) score of at least 2 points from baseline.
- Written informed consent provided by the participant or legally authorized representative.
Who cannot join
- Previous solid organ or bone marrow transplantation.
- Active connective tissue disease (for example, rheumatoid disease or systemic lupus erythematosus) or glomerulonephritis.
- Pregnancy or lactation.
- Current malignancy.
- Treatment within the past 30 days with immunosuppressive drugs (for example, tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, or tacrolimus) or continuous treatment with more than 10 mg/day prednisolone or an equivalent dose of another corticosteroid.
- Use of thymosin drugs within the past 30 days or participation in another clinical study of a drug or device affecting immunity (for example, Xuebijing, ulinastatin, or continuous renal replacement therapy).
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- History of allergy or intolerance to thymalfasin.
- Expected survival of less than 72 hours or a decision to receive restricted life-support treatment (comfort care only).
- Current or previous B-cell lymphoma, multiple myeloma, or leukemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Correlation Between Thymosin Alpha 1 and IgM Levels in Sepsis Patients
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.
Read the detailed description
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.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Thymalfasin
- Keywords
- Thymosin Alpha 1, Immunoglobulin M, Infection Immunity
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymalfasinDrug
Also called Thymosin alpha 1, Zadaxin
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.
| Study group | Role | What they receive |
|---|---|---|
| Thymosin alpha 1 treatment group | Experimental | Adults with sepsis receiving standard clinical care plus thymosin alpha 1 1.6 mg subcutaneously every 12 hours for 5 days. Receives: Drug: Thymalfasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and days 1, 3, 5, and 7 after treatment
Secondary outcomes (5)
Plasma T-Cell-Derived Microvesicle Count
Number of T-cell-derived microvesicles in plasma measured by flow cytometry after differential centrifugation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the 5-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start20 Feb 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Sciclone Pharmaceuticals (China) Co., Ltd.
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Ling Liu, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922954
- Sponsor's protocol ID
- MR-32-26-089085
- Other IDs
- 2025010261
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Correlation Between Thymosin Alpha 1 and IgM Levels in Sepsis Patients
- ClinicalTrials.gov ID
- NCT07922954
- Acronym / sponsor ID
- MR-32-26-089085
- Conditions
- Sepsis, Septic Shock
- Keywords
- Thymosin Alpha 1, Immunoglobulin M, Infection Immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Sciclone Pharmaceuticals (China) Co., Ltd.
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thymosin alpha 1 treatment group | Experimental | Drug: ThymalfasinAdults with sepsis receiving standard clinical care plus thymosin alpha 1 1.6 mg subcutaneously every 12 hours for 5 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 85 years.
- Admitted to the Department of Critical Care Medicine, Zhongda Hospital Southeast University, with sepsis diagnosed according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3.0): confirmed or highly suspected infection with an acute increase in Sequential Organ Failure Assessment (SOFA) score of at least 2 points from baseline.
- Written informed consent provided by the participant or legally authorized representative.
Key exclusion criteria (9 listed)
- Previous solid organ or bone marrow transplantation.
- Active connective tissue disease (for example, rheumatoid disease or systemic lupus erythematosus) or glomerulonephritis.
- Pregnancy or lactation.
- Current malignancy.
- Treatment within the past 30 days with immunosuppressive drugs (for example, tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, or tacrolimus) or continuous treatment with more than 10 mg/day prednisolone or an equivalent dose of another corticosteroid.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThymalfasinAlso: Thymosin alpha 1, ZadaxinThymosin 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. | Drug | Thymosin alpha 1 treatment group |
Primary outcome
Serum IgM Concentration
Time frame: Baseline and days 1, 3, 5, and 7 after treatment
Serum IgM concentration measured by enzyme-linked immunosorbent assay (ELISA) before treatment and on days 1, 3, 5, and 7 after treatment.
5 secondary outcomes
Plasma T-Cell-Derived Microvesicle Count
Time frame: Baseline and days 1, 3, 5, and 7 after treatment
28-Day All-Cause Mortality
Time frame: From enrollment to 28 days after enrollment
ICU Mortality
Time frame: From enrollment to 28 days after enrollment
Hospital Mortality
Time frame: From enrollment to 28 days after enrollment
Organ Dysfunction Scores
Time frame: During the 5-day treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Liu principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thymalfasin in people with Sepsis and Septic Shock, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgM Concentration (time frame: Baseline and days 1, 3, 5, and 7 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.