NCT04901104

Brief Summary

Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy. Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jul 2021

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2021Mar 2027

First Submitted

Initial submission to the registry

May 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

5.5 years

First QC Date

May 24, 2021

Last Update Submit

May 24, 2021

Conditions

Long-term Effects of Thymosin Alpha 1 Treatment

Keywords

long-termthymosin alpha 1sepsisimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • three years mortality

    Mortality rate of patients treated with thymosin α1 or placebo within 3 years

    3 years

Secondary Outcomes (4)

  • Recurrence rate of sepsis

    5 years

  • one year mortality

    1 year

  • Five years mortality

    5 years

  • short form 36 questionnaire

    1 year

Study Arms (2)

thymosin α1 group

The patient was treated with thymosin α1 in sepsis

Drug: Thymosin Alpha1

placebo group

The patient was treated without thymosin α1 in sepsis

Interventions

Thymosin Alpha1DRUG

Drug interventions have been done in previous clinical studies

thymosin α1 group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sepsis patients who discharged from hospital after recovery in the TESTS study

You may qualify if:

  • Sepsis patients in the TESTS study Patients who discharged from hospital after recovery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Sepsis

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThymosinThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsProteins

Central Study Contacts

Jianfeng Wu

CONTACT

020-87755766-8453wujianf@mail.sysu.edu.cn

Fei Pei

CONTACT

020-87755766-8453peif3@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 25, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share