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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • STSA-1002 injection
  • STSA-1002 Injection Placebo

Treatment groups

406 Participants
are divided into 2 treatment groups