Thymalfasin for Immune Recovery in Adults With Sepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy to thymalfasin or any of its excipients. A history of primary or acquired immunodeficiency, such as HIV infection or post-transplant immunosuppression.
Trial design
Design model
Parallel
Treatments tested in this trial
Thymalfasin (Thymosin alpha 1, Ta1)
DrugThymalfasin 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Thymalfasin Plus Standard CareExperimental treatment 1 intervention
Group B: Standard Care AloneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 7Secondary outcomes
1
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 14.2
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 143
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 74
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 7Other outcomes
1
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 282
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 903
Hospital Length of Stay
Duration in days of the index hospitalization.
Time frame
From hospital admission until hospital discharge or death, up to Day 90Sponsors and contacts
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Source ClinicalTrials.gov