RECRUITING Not applicable ClinicalTrials.gov

Thymalfasin for Immune Recovery in Adults With Sepsis

Sponsor: Shanghai Zhongshan Hospital • ClinicalTrials.gov ID: NCT07866118

Registry updated: 2026-10-08

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Thymalfasin (Thymosin alpha 1, Ta1) (Drug)
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.

Eligibility criteria

Inclusion Criteria: * Age older than 18 years, of any sex. Sepsis according to Sepsis-3 criteria, defined as documented or suspected infection with an increase in Sequential Organ Failure Assessment (SOFA) score of at least 2 points from baseline. 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: * Known allergy to thymalfasin or any of its excipients. A history of primary or acquired immunodeficiency, such as HIV infection or post-transplant immunosuppression. 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.

Conditions

Sepsis Immunosuppression

Locations

Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment