Evaluating STSA-1002 Injection for Acute Respiratory Distress Syndrome

Phase Ib/II Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Initial Efficacy of STSA-1002 Injection in Patients with Acute Respiratory Distress Syndrome

This study is testing if the STSA-1002 injection can help adults with acute respiratory distress syndrome from viral pneumonia feel better and recover safely.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd (Industry-sponsored)
• Locations: 30 sites (Bengbu, Anhui and 29 other locations)
• Trial ID: NCT06038916 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and initial efficacy of STSA-1002 injection in patients suffering from acute respiratory distress syndrome (ARDS) caused by viral pneumonia. Participants will be randomly assigned to receive either the STSA-1002 injection or a placebo. The study will focus on patients aged 18 to 85 who have specific respiratory viral infections and meet certain clinical criteria. The trial is designed to gather data on the treatment's effectiveness and safety profile over the course of the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with ARDS due to viral pneumonia and specific clinical indicators.

Not a fit: Patients who have undergone ECMO or have been on invasive mechanical ventilation for more than 48 hours prior to the first dose may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with acute respiratory distress syndrome.

How similar studies have performed: While this approach is novel, similar studies targeting ARDS have shown promise in evaluating new treatments.

Eligibility criteria

Inclusion Criteria:

1. 18 years old≤Age≤85 years old;
2. Pathogen results indicate respiratory viral infection;
3. Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;
4. In 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);
5. PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;
6. Most recent peripheral blood lymphocyte count ≤0.8×10\^9/L prior to randomization;
7. Patients (including patients' partners) has no plans for conception during the study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms);
8. Willing to participate in the study and signs the informed consent form

Exclusion Criteria:

1. Use of ECMO before the first administration;
2. More than 48 hours of invasive mechanical ventilation prior to the first dose;
3. Based on the researchers' overall assessment, the patient's condition improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation indicators observed within the next 48 hours);
4. Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;
5. Recent history of stroke or acute coronary syndrome;
6. Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystis jirovecii pneumonia);
7. Suspected or known cytomegalovirus infection;
8. Suspected or known active tuberculosis;
9. Experienced prolonged fluid resuscitation-resistant septic shock.
10. Severe chronic respiratory failure;
11. Deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases;
12. Cardiogenic pulmonary edema or congestive heart failure;
13. Liver dysfunction;
14. Severe renal impairment or long-term dialysis;
15. Immunocompromised state;
16. A Absolute neutrophil count is excessively low;
17. Severe anemia or active bleeding;
18. Poor compliance with standard treatment;
19. Pregnant or breastfeeding women;
20. Participated in a clinical trial of a new drug and received treatment within 3 months prior to screening;
21. Any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial;
22. Known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs);
23. Any other disease or condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study;

Where this trial is running

Bengbu, Anhui and 29 other locations

• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Luhe Hospital affiliated to Capital Medical University — Beijing, Beijing, China (Recruiting)
• The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University — Chongqing, Chongqing, China (Not_yet_recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Recruiting)
• The Second Hospital of Hebei Medical University City:Shijiazhuang — Shijiazhuang, Hebei, China (Recruiting)
• Huaihe Hospital of Henan University — Kaifeng, Henan, China (Recruiting)
• Kaifeng Central Hospital — Kaifeng, Henan, China (Recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
• The First Affiliated Hospital of Xinxiang Medical College — Xingxiang, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Wuhan Jinyintan Hospital — Wuhan, Hubei, China (Recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Xiangtan Central Hospital — Xiangtan, Hunan, China (Recruiting)
• Zhongda Hospital affiliated to Southeast University — Nanjing, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Jinan Central Hospital — Jinan, Shandong, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
• Zibo Municipal Hospital — Zibo, Shandong, China (Recruiting)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• The First Affiliated Hospital of Xi 'an Jiaotong University — Xi'an, Shanxi, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• The First Affiliated Hospital of Chengdu Medical College — Chengdu, Sichuan, China (Not_yet_recruiting)
• Chengdu Fifth People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Hangzhou Red Cross Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Bin Cao, Ph.D — China-Japan Friendship Hospital
• Study coordinator: Aiping Sun

Conditions Acute Respiratory Distress Syndrome