To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Phase Ib/II Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
1 other identifier
interventional
47
1 country
30
Brief Summary
To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2023
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
December 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2025
CompletedJuly 11, 2025
November 1, 2024
1.3 years
September 8, 2023
July 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical remission time
Baseline to Day28
Secondary Outcomes (10)
28-day all-cause mortality rate
Day28 after first dose
Proportion of subjects achieving clinical remission on Day 14 and Day 28
Day14, Day28 after first dose
Changes in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14
Day3, Day5, Day7, Day10, Day14 after first dose
Change rates in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14
Day3, Day5, Day7, Day10, Day14 after first dose
Proportion of subjects with a decrease in the level of respiratory support by ≥1 grade on Day 28
Day28 after first dose
- +5 more secondary outcomes
Study Arms (3)
Placebo group
PLACEBO COMPARATORPatients in this group will receive basal treatment and placebo.
Low dose group
EXPERIMENTALPatients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
High dose group
EXPERIMENTALPatients in this group will receive basal treatment and High-dose STSA-1002.
Interventions
Eligibility Criteria
You may qualify if:
- years old≤Age≤85 years old;
- Pathogen results indicate respiratory viral infection;
- Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;
- In 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);
- PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;
- Most recent peripheral blood lymphocyte count ≤0.8×10\^9/L prior to randomization;
- Patients (including patients' partners) has no plans for conception during the study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms);
- Willing to participate in the study and signs the informed consent form
You may not qualify if:
- Use of ECMO before the first administration;
- More than 48 hours of invasive mechanical ventilation prior to the first dose;
- Based on the researchers' overall assessment, the patient's condition improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation indicators observed within the next 48 hours);
- Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;
- Recent history of stroke or acute coronary syndrome;
- Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystis jirovecii pneumonia);
- Suspected or known cytomegalovirus infection;
- Suspected or known active tuberculosis;
- Experienced prolonged fluid resuscitation-resistant septic shock.
- Severe chronic respiratory failure;
- Deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases;
- Cardiogenic pulmonary edema or congestive heart failure;
- Liver dysfunction;
- Severe renal impairment or long-term dialysis;
- Immunocompromised state;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233099, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Beijing Luhe Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 101199, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing Municipality, 400038, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530016, China
The Second Hospital of Hebei Medical University City:Shijiazhuang
Shijiazhuang, Hebei, 050011, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 450001, China
Kaifeng Central Hospital
Kaifeng, Henan, 475000, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471099, China
The First Affiliated Hospital of Xinxiang Medical College
Xingxiang, Henan, 453100, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Wuhan Jinyintan Hospital
Wuhan, Hubei, 430048, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062, China
Xiangtan Central Hospital
Xiangtan, Hunan, 411100, China
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, 210009, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266071, China
Zibo Municipal Hospital
Zibo, Shandong, 255000, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610599, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130, China
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325035, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Cao, Ph.D
China-Japan Friendship Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2023
First Posted
September 15, 2023
Study Start
December 9, 2023
Primary Completion
March 20, 2025
Study Completion
April 27, 2025
Last Updated
July 11, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share