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

NCT07208591 | Recruiting Phase 3 DMC

• 1 other identifier: STSA-1002-07
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality rate

  Day28 after first dose

Secondary Outcomes (6)

• 60-day all-cause mortality rate

  Day60 after first dose

• Proportion of subjects with a decrease in the level of respiratory support on Day 28

  Day28 after first dose

• ICU length of stay and total hospitalization time on Day 28

  Day28 after first dose

• Proportion of subjects with PaO2/FiO2 > 300 mmHg or free of respiratory support on Day 28

  Day28 after first dose

• Days alive without invasive mechanical ventilation

  Day28 after first dose

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: STSA-1002 injection

Placebo group

PLACEBO COMPARATOR

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

Drug: STSA-1002 Injection Placebo

Interventions

STSA-1002 injection DRUG

basal treatment + STASA-1002 intravenous infusion

Experimental group

STSA-1002 Injection Placebo DRUG

basal treatment + STSA-1002 Injection Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ ≤ 85 years old;
• laboratory tests results indicate respiratory viral infection;
• Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;
• The time from the onset of respiratory infection-related symptoms to randomization is ≤ 12 days (for patients without invasive mechanical ventilation)/)/≤ 14 days (for patients with invasive mechanical ventilation); Or worsening of respiratory infection-related symptoms within ≤7 days from randomization;
• PaO2/FiO2≤200mmHg;
• The subjects (including their partners) have no plans to have children during the trial and within 3 months after the last dose, and agree to take appropriate and effective contraceptive measures (such as contraceptive pills, condoms, etc.);
• Volunteer to participate in the trial and sign the informed consent form.

You may not qualify if:

• ECMO before the first dose;
• According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;
• The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;
• Patients with stroke or acute coronary syndrome within 3 months before randomization;
• Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;
• Severe chronic respiratory failure;
• Known active pulmonary tuberculosis;
• Combined with liver insufficiency
• Long-term dialysis and/or known severe renal impairment Cytomegalovirus infection;
• Known HIV infection with CD4+ T-lymphocyte count \< 200 cells/μL;
• Organ transplant patients;
• Patients who received radiotherapy and chemotherapy in the past 1 years or the malignant tumor is still in the active phase;
• Septic shock
• Absolute neutrophil count is less than 0.5×109/L;
• Hemoglobin is less than 60g/L, or the researcher judges that there is active gastrointestinal bleeding;

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead

Study Sites (15)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 51063, China

RECRUITING

The Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471099, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Wuhan Central Hospital

Wuhan, Hubei, 430014, China

RECRUITING

Xiangtan Central Hospital

Xiangtan, Hunan, 411100, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Weifang People's Hospital

Weifang, Shandong, 261041, China

RECRUITING

Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Dazhou Central Hospital

Dazhou, Sichuan, 635099, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Bin M.D. Cao

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiping Sun

CONTACT

+8618611103198; sunaiping@staidson.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (15)