To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

NCT ID: NCT06038916

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-09
• Study Completion Date: 2025-04-27

Brief Summary

To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo group

Patients in this group will receive basal treatment and placebo.

Group Type: PLACEBO_COMPARATOR

STSA-1002 Injection Placebo

Intervention Type: DRUG

Intravenous infusion

Low dose group

Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.

Group Type: EXPERIMENTAL

STSA-1002 Injection Placebo

Intervention Type: DRUG

Intravenous infusion

STSA-1002 Injection

Intervention Type: DRUG

Intravenous infusion

High dose group

Patients in this group will receive basal treatment and High-dose STSA-1002.

Group Type: EXPERIMENTAL

STSA-1002 Injection

Intervention Type: DRUG

Intravenous infusion

Interventions

STSA-1002 Injection Placebo

Intravenous infusion

Intervention Type: DRUG

STSA-1002 Injection

Intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 years old≤Age≤85 years old;

2. Pathogen results indicate respiratory viral infection;

3. Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;

4. In 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);

5. PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;

6. Most recent peripheral blood lymphocyte count ≤0.8×10^9/L prior to randomization;

7. 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);

8. Willing to participate in the study and signs the informed consent form

Exclusion Criteria

1. Use of ECMO before the first administration;

2. More than 48 hours of invasive mechanical ventilation prior to the first dose;

3. 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);

4. Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;

5. Recent history of stroke or acute coronary syndrome;

6. Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystis jirovecii pneumonia);

7. Suspected or known cytomegalovirus infection;

8. Suspected or known active tuberculosis;

9. Experienced prolonged fluid resuscitation-resistant septic shock.

10. Severe chronic respiratory failure;

11. Deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases;

12. Cardiogenic pulmonary edema or congestive heart failure;

13. Liver dysfunction;

14. Severe renal impairment or long-term dialysis;

15. Immunocompromised state;

16. A Absolute neutrophil count is excessively low;

17. Severe anemia or active bleeding;

18. Poor compliance with standard treatment;

19. Pregnant or breastfeeding women;

20. Participated in a clinical trial of a new drug and received treatment within 3 months prior to screening;

21. Any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial;

22. Known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs);

23. Any other disease or condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin Cao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Beijing Luhe Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

Chongqing, Chongqing Municipality, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

The Second Hospital of Hebei Medical University City:Shijiazhuang

Shijiazhuang, Hebei, China

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Kaifeng Central Hospital

Kaifeng, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical College

Xingxiang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Wuhan Jinyintan Hospital

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Xiangtan Central Hospital

Xiangtan, Hunan, China

Zhongda Hospital affiliated to Southeast University

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Zibo Municipal Hospital

Zibo, Shandong, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Chengdu Fifth People's Hospital

Chengdu, Sichuan, China

Hangzhou Red Cross Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

STSA-1002-04

Identifier Type: -

Identifier Source: org_study_id