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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• 28-day all-cause mortality rate [Срок оценки: Day28 after first dose]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 15 центров

• China-Japan Friendship Hospital — Пекин
• The First Affiliated Hospital of Xiamen University — Xiamen
• The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• 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 — Чжэнчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• … и ещё 7 центров

Идентификаторы

NCT: NCT07208591 · STSA-1002-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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