Clinical trial NCT06038916: To Evaluate the Safety and Initial Efficacy of STSA-1002 Injection in Patients with Acute Respiratory Distress Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.


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;

Primary outcomes:
measure: Clinical remission time
timeFrame: Baseline to Day28
Secondary outcomes:
measure: 28-day all-cause mortality rate
timeFrame: Day28 after first dose
measure: Proportion of subjects achieving clinical remission on Day 14 and Day 28
timeFrame: Day14, Day28 after first dose
measure: Changes in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14
timeFrame: Day3, Day5, Day7, Day10, Day14 after first dose
measure: Change rates in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14
timeFrame: Day3, Day5, Day7, Day10, Day14 after first dose
measure: Proportion of subjects with a decrease in the level of respiratory support by ≥1 grade on Day 28
timeFrame: Day28 after first dose
measure: ICU length of stay and total hospitalization time on Day 28 (V10)
timeFrame: Day28 after first dose
measure: Proportion of subjects discharged from the ICU on Day 28
timeFrame: Day28 after first dose
measure: Proportion of subjects with PaO2/FiO2 > 300 mmHg on Day 28±2 (V10)
timeFrame: Day28 after first dose
measure: Time without ventilator use (invasive or non-invasive) within 28 days
timeFrame: Day28 after first dose
measure: Proportion of subjects alive and not receiving mechanical ventilation on Day 28
timeFrame: Day28 after first dose
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
state: Anhui
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital affiliated to Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
state: Chongqing
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University City:Shijiazhuang
state: Hebei
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Xingxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Jinyintan Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital affiliated to Southeast University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: The First Affiliated Hospital of Chengdu Medical College
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou Red Cross Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bin Cao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: