An interventional study of Thymalfasin (Thymosin alpha 1, Ta1) in Sepsis and Immunosuppression, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
Sepsis is a life-threatening illness caused by an abnormal response to infection. Some people with sepsis have reduced immune function, which may make recovery more difficult. This study will examine whether adding thymalfasin, also called thymosin alpha-1, to usual sepsis care improves recovery of immune function.
The study will enroll 60 adults with sepsis and evidence of reduced immune function at Zhongshan Hospital, Fudan University. Participants will be assigned by chance to one of two groups. Thirty participants will receive usual care plus a 1.6 mg thymalfasin injection under the skin twice daily for 7 days. Thirty participants will receive usual care alone, without study-drug or placebo injections.
Participants and treating clinicians will know which treatment is given, but laboratory staff measuring immune outcomes will not know the assigned group. The main outcome is the change in monocyte HLA-DR expression, a blood marker of immune function, between baseline and Day 7. Other assessments include immune cells, organ function, organ support, infections, survival, and safety. Scheduled follow-up continues through Day 90. The study is designed primarily to assess an immune marker; it is not sized to establish a definitive survival benefit.
This investigator-initiated, single-center, prospective, randomized, controlled exploratory study will evaluate thymalfasin in adults with sepsis and an immunosuppressed phenotype. The study will be conducted in the Department of Critical Care Medicine at Zhongshan Hospital, Fudan University.
Eligible participants will meet Sepsis-3 criteria, have an Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 15 to 30 at ICU admission, and meet the protocol-defined monocyte HLA-DR eligibility criterion. Enrollment must occur within 48 hours of sepsis onset. Written informed consent will be obtained from the participant or a legally authorized representative.
Sixty participants will be randomized in a 1:1 ratio. The experimental group will receive standard sepsis care plus thymalfasin 1.6 mg subcutaneously twice daily, approximately 12 hours apart, for 7 consecutive days. The control group will receive standard sepsis care alone. Standard care will be determined by the treating clinicians and may include infection source control, antimicrobial therapy, fluid resuscitation, vasopressors, and organ support as clinically indicated.
The primary outcome is the change in monocyte HLA-DR expression from baseline before randomization to Day 7. Expression will be assessed by flow cytometry using Panel 1 of the six-panel immunophenotyping method and summarized as the median HLA-DR fluorescence intensity within the prespecified monocyte population. Full-panel immune assessments are scheduled at baseline and Day 7, with core assessments at Days 1, 3, and 14. The protocol specifies immune recovery slopes using measurements at baseline and Days 3, 7, and 14. Samples will be coded, and laboratory personnel will be blinded to treatment allocation.
Secondary assessments will characterize immune recovery, T-cell phenotypes, natural killer cells, organ dysfunction, organ support, and survival. Mortality comparisons are exploratory because the sample size is based on the primary immunological outcome. Safety events will be assessed during the protocol-defined monitoring period. Scheduled survival follow-up continues through Day 90.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 60 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Shanghai Zhongshan Hospital is the lead sponsor of 638 studies on the registry; 285 are open to participants now.
Counted across the registry records on this site, refreshed daily.
APACHE II score of 15 to 30, inclusive, at ICU admission. An immunosuppressed phenotype, defined by reduced monocyte HLA-DR expression meeting No more than 48 hours from sepsis onset to enrollment. Written informed consent provided by the participant or legally authorized representative.
Exclusion Criteria:
Treatment with immunosuppressive agents or immunostimulants within 3 months before enrollment, including systemic corticosteroids at a prednisone-equivalent dose greater than 20 mg/day for at least 7 consecutive days, cyclosporine, tacrolimus, or azathioprine.
Active malignancy or ongoing anticancer treatment. Chronic liver disease classified as Child-Pugh class C, or end-stage renal disease requiring maintenance dialysis.
Pregnancy or breastfeeding. Expected survival of less than 48 hours at enrollment, such as irreversible brain death after cardiac arrest or terminal multiple organ failure.
Concurrent participation in another interventional clinical trial. Any other condition that, in the investigator's judgment, makes participation unsuitable.
Participants will receive standard sepsis care plus thymalfasin 1.6 mg subcutaneously twice daily, approximately 12 hours apart, for 7 consecutive days (Days 1 to 7). Thirty participants are planned for this arm.
Drug: Thymalfasin (Thymosin alpha 1, Ta1)
Participants will receive standard sepsis care determined by the treating clinicians, including infection source control, antimicrobial therapy, fluid resuscitation, vasopressors, and organ support as clinically indicated. No thymalfasin or placebo injections will be given as study interventions. Thirty participants are planned for this arm.
Thymalfasin lyophilized powder for injection, 1.6 mg per vial, will be reconstituted with 1 mL of 0.9% sodium chloride and administered subcutaneously at a dose of 1.6 mg twice daily, approximately 12 hours apart, for 7 consecutive days. Injection sites will be rotated between the upper arm and abdomen.
Change From Baseline in Monocyte HLA-DR Expression at Day 7
Monocyte HLA-DR expression will be assessed by standardized multiparametric flow cytometry according to the six-panel immunophenotyping method and reported as median fluorescence intensity (MFI). Change will be calculated as the Day 7 MFI minus the baseline MFI measured before randomization. A positive change indicates increased monocyte HLA-DR expression.
Time frame: Baseline (Day 0, before randomization) and Day 7
Recovery Slope of Monocyte HLA-DR Expression Through Day 14
The recovery slope will be estimated using a linear mixed-effects model based on monocyte HLA-DR median fluorescence intensity (MFI) measured at baseline and Days 3, 7, and 14. Monocyte HLA-DR expression will be assessed by standardized multiparametric flow cytometry. The slope will be expressed as change in MFI per day.
Time frame: Baseline and Days 3, 7, and 14.
Recovery Slope of Absolute Lymphocyte Count Through Day 14
The recovery slope of absolute lymphocyte count will be estimated using a linear mixed-effects model based on absolute lymphocyte counts obtained from routine complete blood count measurements at baseline and Days 3, 7, and 14. The slope will be expressed as change in ×10⁹/L per day.
Time frame: Baseline and Days 3, 7, and 14
Change From Baseline in PD-1 Expression on CD8-Positive T Cells at Day 7
PD-1 expression on CD8-positive T cells will be assessed by standardized multiparametric flow cytometry and reported as median fluorescence intensity (MFI). Change will be calculated as the Day 7 MFI minus the baseline MFI.
Time frame: Baseline (Day 0) and Day 7
Absolute Natural Killer Cell Count at Baseline and Day 7
Absolute natural killer (NK) cell counts will be assessed at baseline and Day 7 and reported as ×10⁹/L.
Time frame: Baseline (Day 0) and Day 7
Reduction From Baseline in Sequential Organ Failure Assessment Score Through Day 14
The Sequential Organ Failure Assessment (SOFA) score will be assessed at baseline and Days 3, 7, and 14. Reduction will be calculated as the baseline score minus the score at each follow-up assessment. Total scores range from 0 to 24; higher scores indicate more severe organ dysfunction. A positive reduction indicates improvement.
Time frame: Baseline and Days 3, 7, and 14
Mechanical Ventilation-Free Days Through Day 28
Number of days without mechanical ventilation from randomization through Day 28.
Time frame: From randomization through Day 28
Vasopressor-Free Days Through Day 28
Number of days without vasopressor therapy from randomization through Day 28.
Time frame: From randomization through Day 28
Renal Replacement Therapy-Free Days Through Day 28
Number of days without continuous renal replacement therapy (CRRT) from randomization through Day 28.
Time frame: From randomization through Day 28
All-Cause Mortality During the Index ICU Stay
Percentage of participants who die from any cause during the index ICU stay after enrollment. This outcome is exploratory.
Time frame: From enrollment until ICU discharge or death, up to Day 90
All-Cause Mortality During the Index Hospitalization
Percentage of participants who die from any cause during the index hospitalization after enrollment. This outcome is exploratory.
Time frame: From enrollment until hospital discharge or death, up to Day 90
All-Cause Mortality Within 28 Days After Randomization
Percentage of participants who die from any cause within 28 days after randomization. This is an exploratory outcome; the trial is sized for the primary immunological outcome rather than a definitive mortality comparison.
Time frame: From randomization through Day 28
All-Cause Mortality Within 90 Days After Randomization
Percentage of participants who die from any cause within 90 days after randomization. This is an exploratory outcome; the trial is sized for the primary immunological outcome rather than a definitive mortality comparison.
Time frame: From randomization through Day 90
Participants With at Least One Adverse Event
Percentage of participants experiencing at least one adverse event during the treatment and follow-up periods. Adverse event severity will be graded using CTCAE version 5.0, and events will be coded using MedDRA.
Time frame: From enrollment through Day 90
Participants With at Least One Serious Adverse Event
Percentage of participants experiencing at least one serious adverse event during the study period, as defined in the study protocol.
Time frame: From enrollment through Day 90
Participants With a Thymalfasin-Related Adverse Event
Percentage of participants receiving thymalfasin who experience at least one adverse event judged by the investigator to be related to the study drug.
Time frame: From the first study-drug dose through Day 90
Participants With an Injection-Site Reaction
Percentage of participants receiving thymalfasin who experience at least one local injection-site reaction during the 7-day study-drug treatment period.
Time frame: From the first dose through Day 7
NKp46 Expression on Natural Killer Cells at Baseline and Day 7
NKp46 expression on natural killer (NK) cells will be assessed by standardized multiparametric flow cytometry and reported as median fluorescence intensity (MFI) at baseline and Day 7.
Time frame: Baseline (Day 0) and Day 7
Participants With a New Hospital-Acquired Infection Within 28 Days
Percentage of participants with at least one new hospital-acquired infection within 28 days after randomization, including ventilator-associated pneumonia or catheter-related bloodstream infection. A new infection will be distinguished from the infection present at study enrollment based on clinical, microbiological, and imaging findings as appropriate.
Time frame: From randomization through Day 28
ICU Length of Stay
Duration in days of the index ICU stay.
Time frame: From ICU admission until ICU discharge or death, up to Day 90
Hospital Length of Stay
Duration in days of the index hospitalization.
Time frame: From hospital admission until hospital discharge or death, up to Day 90
Plan to share: No — There is currently no plan to share individual participant data outside the study team. Aggregate findings will be disseminated through scientific publications and presentations. Any future proposal for external sharing of de-identified participant data will be subject to institutional and ethics review and an appropriate consent and data-governance basis.
No publications or documents are linked to this record.
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 ↗
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