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NCT Number: NCT07208591

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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.

Exclusion criteria

  • 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;
  • Severe underlying diseases with poor compliance with basic treatment;17. Pregnant or lactating women;
  • Participated in new drug clinical trials and medication within 3 months before screening; 19. Allergic or allergic to any component of the trial drug and its excipients (such as allergic to two or more drugs); 20. Other diseases or conditions that the investigator considers unsuitable for participation in this trial.

Treatment and study plan

STSA-1002 Injection

Drug

basal treatment + STASA-1002 intravenous infusion

STSA-1002 Injection Placebo

Drug

basal treatment + STSA-1002 Injection Placebo

Primary outcomes

  1. 28-day all-cause mortality rate

    Time frame: Day28 after first dose

Secondary outcomes

  1. 60-day all-cause mortality rate

    Time frame: Day60 after first dose

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

    Time frame: Day28 after first dose

  3. ICU length of stay and total hospitalization time on Day 28

    Time frame: Day28 after first dose

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

    Time frame: Day28 after first dose

  5. Days alive without invasive mechanical ventilation

    Time frame: Day28 after first dose

  6. Changes in SOFA values from baseline on Day 3, 7, 10, and 14

    Time frame: Day14 after first dose

Study contacts

Contact information is provided by the study sponsor or research team.

Aiping Sun

CONTACT

[email protected]

+8618611103198

Sponsors and collaborators

Lead sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Industry

Registry information

Official study title

Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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