Long-term Prognosis of Patients With Sepsis After Immunot... | NCT04901104

Studies
Long-term Prognosis of Patients With Sepsis After Immunotherapy

NCT04901104

Sponsor

Sun Yat-sen University

Status

Not yet recruiting

Last Update Posted

May 25, 2021Actual

Enrollment

900Estimated

Phase

Not provided

Conditions

Long-term Effects of Thymosin Alpha 1 Treatment

Interventions

Thymosin Alpha1

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

May 24, 2021

First Submission Date that Met QC Criteria

May 24, 2021

First Posted Date

May 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2021

Last Update Posted Date

May 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

900Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Thymosin Alpha1	Drug	Drug interventions have been done in previous clinical studies	thymosin α1 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
three years mortality	Mortality rate of patients treated with thymosin α1 or placebo within 3 years	3 years

Secondary Outcomes

Measure	Description	Time Frame
Recurrence rate of sepsis	Percentage of recurrent sepsis within 5 years of discharge sepsis patients	5 years
one year mortality	Mortality rate of patients treated with thymosin α1 or placebo within 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfeng Wu	Contact	020-87755766-8453		wujianf@mail.sysu.edu.cn
Fei Pei	Contact	020-87755766-8453		peif3@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Not provided

Label	URL
This study is a follow-up study of TESTS study	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077596	Thymalfasin

Ancestor Terms

ID	Term
D013947	Thymosin
D013951	Thymus Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided