Phase
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
STSA-1002 Injection Placebo
STSA-1002 Injection
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years old≤Age≤85 years old;
Pathogen results indicate respiratory viral infection;
Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;
In 14haode days since the onset of respiratory infective symptoms (in 12 days fornon-invasive mechanical ventilation patients);
PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;
Most recent peripheral blood lymphocyte count ≤0.8×10^9/L prior to randomization;
Patients (including patients' partners) has no plans for conception during the studyperiod and within 4 months following the last dose, and agrees to use appropriateand effective contraception (e.g., birth control pills, condoms);
Willing to participate in the study and signs the informed consent form
Exclusion
Exclusion Criteria:
Use of ECMO before the first administration;
More than 48 hours of invasive mechanical ventilation prior to the first dose;
Based on the researchers' overall assessment, the patient's condition improvedwithin the first 48 hours prior to the initial dosing (predictable improvement inoxygenation indicators observed within the next 48 hours);
Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;
Recent history of stroke or acute coronary syndrome;
Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystisjirovecii pneumonia);
Suspected or known cytomegalovirus infection;
Suspected or known active tuberculosis;
Experienced prolonged fluid resuscitation-resistant septic shock.
Severe chronic respiratory failure;
Deemed by the investigator as difficult to wean from ventilation due to severeunderlying diseases;
Cardiogenic pulmonary edema or congestive heart failure;
Liver dysfunction;
Severe renal impairment or long-term dialysis;
Immunocompromised state;
A Absolute neutrophil count is excessively low;
Severe anemia or active bleeding;
Poor compliance with standard treatment;
Pregnant or breastfeeding women;
Participated in a clinical trial of a new drug and received treatment within 3months prior to screening;
Any condition that the investigator believes may increase the risk to the patient orinterfere with the execution of the clinical trial;
Known allergy to any component of the investigational drug or its excipients, or ahistory of hypersensitivity (e.g., allergic to two or more drugs);
Any other disease or condition that, in the investigator's opinion, makes thepatient unsuitable for participation in this study;
Study Design
Connect with a study center
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui 233099
ChinaActive - Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui 233099
ChinaSite Not Available
Beijing Luhe Hospital affiliated to Capital Medical University
Beijing, Beijing 101199
ChinaSite Not Available
China-Japan Friendship Hospital
Beijing, Beijing 100029
ChinaSite Not Available
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing 400038
ChinaSite Not Available
Peking University Shenzhen Hospital
Shenzhen, Guangdong 518036
ChinaSite Not Available
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi 530016
ChinaSite Not Available
The Second Hospital of Hebei Medical University City:Shijiazhuang
Shijiazhuang, Hebei 050011
ChinaSite Not Available
Huaihe Hospital of Henan University
Kaifeng, Henan 450001
ChinaSite Not Available
Kaifeng Central Hospital
Kaifeng, Henan 475000
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan 471099
ChinaSite Not Available
The First Affiliated Hospital of Xinxiang Medical College
Xingxiang, Henan 453100
ChinaSite Not Available
Henan Provincial People's Hospital
Zhengzhou, Henan 450003
ChinaSite Not Available
Wuhan Jinyintan Hospital
Wuhan, Hubei 430048
ChinaSite Not Available
Zhongnan Hospital of Wuhan University
Wuhan, Hubei 430062
ChinaSite Not Available
Xiangtan Central Hospital
Xiangtan, Hunan 411100
ChinaSite Not Available
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu 210009
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaSite Not Available
Jinan Central Hospital
Jinan, Shandong 250013
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan, Shandong 250012
ChinaSite Not Available
Qingdao Municipal Hospital
Qingdao, Shandong 266071
ChinaSite Not Available
Zibo Municipal Hospital
Zibo, Shandong 255000
ChinaSite Not Available
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai 200001
ChinaSite Not Available
Shanxi Bethune Hospital
Taiyuan, Shanxi 030032
ChinaSite Not Available
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shanxi 710061
ChinaSite Not Available
Chengdu Fifth People's Hospital
Chengdu, Sichuan 611130
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu, Sichuan 610072
ChinaSite Not Available
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan 610599
ChinaSite Not Available
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang 310003
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325035
ChinaSite Not Available

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