Phase
Condition
Pneumonia (Pediatric)
Pneumonia
Treatment
Placebo capsule+regular treatments
SR1375 capsule 3mg+regular treatments
SR1375 capsule 1mg+regular treatments
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
The subject or their legally acceptable representative (LAR) has voluntarily signedthe informed consent form (ICF) prior to any study-related procedures, and thesubject is willing and able to comply with all study requirements, restrictions, andprocedures. If consent is provided by an LAR for a subject with limited or nocapacity to consent, re-consenting may be performed if the subject regains capacity.
Aged 18 to 85 years.
Diagnosis of CAP
Prior to screening, the subject has been receiving standard-of-care treatment forpneumonia in a medical institution, including at least 3 days of intravenous (IV)anti-infective therapy, with no clinical improvement.
Chest CT showing multi-lobar infiltrates, and for subjects not receiving invasivemechanical ventilation, an oxygenation index (PaO2/FiO2 ratio) between 100 and 300mmHg.
Expected to require continued hospitalization for at least 7 days from the time ofsigning the ICF.
Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygensaturation ≤ 93% without oxygen inhalation, 6 points or 7points. (5 points refer tohospitalization with oxygen therapy; 6 points refer to hospitalization with highflow oxygen therapy or non-invasive mechanical ventilation. 7 points refer tohospitalization with invasive mechanical ventilation).High oxygen flow refers to ≥ 4L/min.)
With ≥ 1 high risk factors including chronic obstructive pulmonary disease (COPD),pulmonary fibrosis, type 2 diabetes, chronic kidney disease, coronary heart disease,age ≥ 65 years, moderate obesity (body mass index>32.5kg/m2), etc.
Participants of women of childbearing potential(WOCBP) and male participants withWOCBP partners must agree to use one or more effective contraceptive methods duringthe treatment period and until 90 days after the last administration.
Exclusion
Key Exclusion Criteria:
Patients who are currently receiving or are expected to require ECMO treatmentwithin 24 hours.
Presence of active tuberculosis (TB) or severe asthma.
History of unstable angina or acute myocardial infarction within 3 months prior toscreening, or stroke within 4 weeks prior to screening.
Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeksprior to randomization, or are planned to receive such treatment during the studyperiod; presence of a hematological malignancy not in complete remission; or a lungtumor with concurrent obstructive pneumonia.
Presence of any concomitant disease that is expected to result in death within 12weeks after randomization.
Prior use of JAK inhibitors (e.g., Baricitinib), interleukin receptor inhibitors (e.g., Tocilizumab), or any investigational drug in another clinical trial, wherethe last dose was administered less than 5 half-lives before the first dose of thestudy drug in this trial.
ALT) or AST > 3 times the upper limit of normal (ULN).
eGFR < 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease EpidemiologyCollaboration [CKD-EPI] formula); however, patients undergoing dialysis may beincluded upon the investigator's assessment of their suitability for the trial.
Presence of clinically significant abnormalities on ECG that may seriously affectsubject safety, e.g., QTcF > 480 ms.
Female subjects who are pregnant, lactating, or have a positive serum β-HCGpregnancy test.
Presence of any severe systemic disease or clinical condition that, in theinvestigator's judgment, makes the subject unsuitable for participation in thisstudy.
Study Design
Study Description
Connect with a study center
Fuyang People's Hospital
Fuyang, Anhui 236001
ChinaActive - Recruiting
Peking University Third Hospital
Beijing, Beijing 100191
ChinaActive - Recruiting
Zhangzhou Hospital
Zhangzhou, Fujian 363000
ChinaActive - Recruiting
Gaozhou People's Hospital
Gaozhou, Guangdong 525200
ChinaActive - Recruiting
Nanfang Hospital
Guangzhou, Guangdong 515399
ChinaActive - Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong 510630
ChinaActive - Recruiting
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong 515041
ChinaActive - Recruiting
Yulin First People's Hospital
Yulin, Guangxi 537000
ChinaActive - Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 050023
ChinaActive - Recruiting
Daqing Longnan Hospital
Daqing, Heilongjiang 163000
ChinaActive - Recruiting
Daqing People's Hospital
Daqing, Heilongjiang 163000
ChinaActive - Recruiting
Shangqiu People's Hospital
Shangqiu, Henan 476100
ChinaActive - Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan 450003
ChinaActive - Recruiting
Yueyang Central Hospital
Yueyang, Hunan 414000
ChinaActive - Recruiting
Nanjing First Hospital
Nanjing, Jiangsu 210006
ChinaSite Not Available
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Yanbian University Affiliated Hospital
Yanbian, Jilin 133000
ChinaSite Not Available
Dalian Central Hospital
Dalian, Liaoning 116021
ChinaActive - Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning 116021
ChinaActive - Recruiting
Weifang Second People's Hospital
Weifang, Shandong 261041
ChinaActive - Recruiting
Zibo Municipal Hospital
Zibo, Shandong 255100
ChinaActive - Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai 200433
ChinaActive - Recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai 200335
ChinaActive - Recruiting
Zhongshan Hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan 610500
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Lishui Central Hospital
Lishui, Zhejiang 323000
ChinaActive - Recruiting
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