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Tests treatment safety and results for Community-acquired Pneumonia
Official title Efficacy and Safety of SR1375 in Adult Patients With CAP
ClinicalTrials.gov ID: NCT06577558
What this study is testing
What is SR1375 capsule 3mg+regular treatments?
SR1375 capsule 3mg+regular treatments is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for community-acquired pneumonia.
Also referred to as SR1375 capsule high dose+regular treatments.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2 study to evaluate the efficacy and safety of SR1375 in hospitalized adult patients with CAP. Patients will receive SR1375 or placebo for 8 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- The subject or their legally acceptable representative (LAR) has voluntarily signed the informed consent form (ICF) prior to any study-related...
- Aged 18 to 85 years.
- Diagnosis of CAP
- Prior to screening, the subject has been receiving standard-of-care treatment for pneumonia in a medical institution, including at least 3 days of...
- Chest CT showing multi-lobar infiltrates, and for people not receiving invasive mechanical ventilation, an oxygenation index (PaO2/FiO2 ratio)...
You likely can't join if
- Patients who are currently receiving or are expected to require ECMO treatment within 24 hours.
- Presence of active tuberculosis (TB) or severe asthma.
- History of unstable angina or acute myocardial infarction within 3 months prior to screening, or stroke within 4 weeks prior to screening.
- Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeks prior to randomization, or are planned to receive such treatment...
- Presence of any concomitant disease that is expected to result in death within 12 weeks after randomization.
- Prior use of JAK inhibitors (e.g., Baricitinib), interleukin receptor inhibitors (e.g., Tocilizumab), or any investigational drug in another clinical...
See the full eligibility criteria
- The subject or their legally acceptable representative (LAR) has voluntarily signed the informed consent form (ICF) prior to any study-related procedures, and the subject is willing and able to comply with all study...
- Aged 18 to 85 years.
- Diagnosis of CAP
- Prior to screening, the subject has been receiving standard-of-care treatment for pneumonia 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 people not receiving invasive mechanical ventilation, an oxygenation index (PaO2/FiO2 ratio) between 100 and 300 mmHg.
- Expected to require continued hospitalization for at least 7 days from the time of signing the ICF.
- Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygen saturation ≤ 93% without oxygen inhalation, 6 points or 7points. (5 points refer to hospitalization with oxygen therapy; 6 points refer to...
- 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...
- Participants of women of childbearing potential(WOCBP) and male participants with WOCBP partners must agree to use one or more effective contraceptive methods during the treatment period and until 90 days after the last...
- Patients who are currently receiving or are expected to require ECMO treatment within 24 hours.
- Presence of active tuberculosis (TB) or severe asthma.
- History of unstable angina or acute myocardial infarction within 3 months prior to screening, or stroke within 4 weeks prior to screening.
- Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeks prior to randomization, or are planned to receive such treatment during the study period; presence of a hematological malignancy not in...
- Presence of any concomitant disease that is expected to result in death within 12 weeks after randomization.
- Prior use of JAK inhibitors (e.g., Baricitinib), interleukin receptor inhibitors (e.g., Tocilizumab), or any investigational drug in another clinical trial, where the last dose was administered less than 5 half-lives...
- ALT) or AST \> 3 times the upper limit of normal (ULN).
- eGFR \< 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula); however, patients undergoing dialysis may be included upon the investigator's assessment of their...
- Presence of clinically significant abnormalities on ECG that may seriously affect subject safety, e.g., QTcF \> 480 ms.
- Female people who are pregnant, lactating, or have a positive serum β-HCG pregnancy test.
- Presence of any severe systemic disease or clinical condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Fuyang, Anhui, China
- Beijing, Beijing Municipality, China
- Zhangzhou, Fujian, China
- Gaozhou, Guangdong, China
- Guangzhou, Guangdong, China
- Shantou, Guangdong, China
- Yulin, Guangxi, China
- Shijiazhuang, Hebei, China
- Daqing, Heilongjiang, China
- Shangqiu, Henan, China
- Zhengzhou, Henan, China
- Yueyang, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Yanbian, Jilin, China
- Dalian, Liaoning, China
- Weifang, Shandong, China
- Zibo, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuyang, Anhui, China; Beijing, Beijing Municipality, China; Zhangzhou, Fujian, China; Gaozhou, Guangdong, China; Guangzhou, Guangdong, China; Shantou, Guangdong, China and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.