The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis
Our previous study reported that the 7-day treatment of Ta 1 demonstrated positive active effect as to the 28-day all-cause mortality and the augmentation of mHLA-DR (monocyte Human Leukocyte Antigen DR) at the secondary endpoint. Therefore, we intend to verify this finding through a randomized, double-blind and placebo-controlled clinical trial and the trail will include subjects with impaired immunologic functions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,106
Subcutaneous injections of 1.6 mg thymosin alpha 1 every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
Subcutaneous injections of placebo every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
28-day all-cause mortality
Time frame: 28 days
Incidence of new onset infection within 28 days
from initial injection on day 0 to day 28
Time frame: 28 days
28-day clearance rate of pathogenic microorganism
Time frame: 28 days
ICU stays
Time frame: 90 days
Hospital stays
Time frame: 28 days
28-day re-hospitalization rate
Time frame: 28 days
Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28
Time frame: 28 days
90-day all-cause mortality
Time frame: 90 days
ICU mortality
Time frame: 90 days
Ventilator-free days within 28 days
Time frame: 28 days
ICU-free days within 28 days
Time frame: 28 days
CRRT-free days within 28 days
Time frame: 28 days
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
...and 12 more locations
Vasoactive agents-free days within 28 days
Time frame: 28 days
90-day SF-36 QOL scale
Time frame: 90 days
Variance of the count of monocyte human lymphocyte antigens-DR (mHLA-DR) at days 7, 14 and 28 compared with the baseline at screening
Time frame: 28 days
The percentage of Treg cells at screening and days 7
Time frame: 7 days