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Recruiting NCT07208591

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

Phase III Interventional Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STSA-1002 injection, STSA-1002 Injection Placebo.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug STSA-1002 injection
    basal treatment + STASA-1002 intravenous infusion
  • Drug STSA-1002 Injection Placebo
    basal treatment + STSA-1002 Injection Placebo

Primary outcome measures

  • 28-day all-cause mortality rate [Time frame: Day28 after first dose]
Secondary outcome measures (6)
  • 60-day all-cause mortality rate [Time frame: Day60 after first dose]
  • Proportion of subjects with a decrease in the level of respiratory support on Day 28 [Time frame: Day28 after first dose]
  • ICU length of stay and total hospitalization time on Day 28 [Time frame: Day28 after first dose]
  • Proportion of subjects with PaO2/FiO2 > 300 mmHg or free of respiratory support on Day 28 [Time frame: Day28 after first dose]
  • Days alive without invasive mechanical ventilation [Time frame: Day28 after first dose]
  • Changes in SOFA values from baseline on Day 3, 7, 10, and 14 [Time frame: Day14 after first dose]

Eligibility criteria

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;

18\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 15 centers
  • China-Japan Friendship Hospital — Beijing
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
  • The Affiliated Hospital of Zunyi Medical University — Zunyi
  • The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
  • Henan Provincial People's Hospital — Zhengzhou
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • … and 7 more centers

Identifiers

NCT: NCT07208591 · STSA-1002-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗