Evaluating SR1375 for treating community-acquired pneumonia in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study aims to assess the efficacy and safety of SR1375 in hospitalized adult patients diagnosed with community-acquired pneumonia (CAP). Participants will be randomly assigned to receive either SR1375 at varying doses or a placebo for a duration of 8 weeks, followed by a 14-day safety follow-up. The study will involve around 240 subjects, with treatment assignments kept blinded to ensure unbiased results. Eligibility is determined based on specific clinical criteria, including the severity of pneumonia and the presence of high-risk factors.

Why it matters

Who can join: the full rules

Key Inclusion 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 requirements, restrictions, and procedures. If consent is provided by an LAR for a subject with limited or no capacity 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 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 subjects 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 hospitalization with high flow oxygen therapy or non-invasive mechanical ventilation. 7 points refer to hospitalization with invasive mechanical ventilation).High oxygen flow refers to ≥ 4 L/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 with WOCBP partners must agree to use one or more effective contraceptive methods during the treatment period and until 90 days after the last administration.

Key Exclusion Criteria:

* 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 complete remission; or a lung tumor with concurrent obstructive pneumonia.
* 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 before the first dose of the study 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 Epidemiology Collaboration \[CKD-EPI\] formula); however, patients undergoing dialysis may be included upon the investigator's assessment of their suitability for the trial.
* Presence of clinically significant abnormalities on ECG that may seriously affect subject safety, e.g., QTcF \> 480 ms.
* Female subjects 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.

Where it's running

• Fuyang People's Hospital
  Fuyang, Anhui, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Zhangzhou Hospital
  Zhangzhou, Fujian, China Recruiting
• Gaozhou People's Hospital
  Gaozhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Third Affiliated Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Weimin Li, MD — West China Hospital
• Study coordinator: Wang, PhD
• Email: fwang@simrbio.com
• Phone: (086)021-68161783

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How frailty affects outcomes in older people with pneumonia in the ER

  This study will test whether a quick bedside frailty score (the Clinical Frailty Scale) can help predict short-term death and serious complications in people aged 65 and older who come to the emergency department with pneumonia.

  Recruiting Ege University · Izmir, Bornova · NCT07442656

• Fever clinic tracking of acute respiratory infections

  This project follows adults who come to a fever clinic with respiratory infections to see how their symptoms, test results, and outcomes change over time.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT07278700

• Azithromycin versus doxycycline as atypical coverage for adults hospitalized with community-acquired pneumonia on a beta-lactam

  This trial will test whether adding azithromycin or doxycycline to a beta-lactam works better and is safer for adults hospitalized with community-acquired pneumonia.

  Recruiting Phase 4 Mayo Clinic · Scottsdale, Arizona and 4 other locations · NCT07164131

• Noninvasive breathing support for severe community-acquired pneumonia

  This trial tests whether high-velocity nasal insufflation (HVNI) or standard noninvasive ventilation (NIV) better helps adults with community-acquired pneumonia and low oxygen levels avoid intubation or death within 48 hours.

  Recruiting Assiut University · Asyut, Assuit · NCT06996834

• Antibiotic strategies for young children with pneumonia in outpatient care

  This trial will see if a 'watch-and-wait' Safety Net Antibiotic Prescribing (SNAP) approach can safely reduce antibiotic use compared with immediate antibiotics in children aged 12 months to under 6 years with mild community-acquired pneumonia.

  Recruiting at 4 sites Ann & Robert H Lurie Children's Hospital of Chicago · Atlanta, Georgia and 3 other locations · NCT06986148

• Awake prone positioning for adults with community-acquired pneumonia on high-flow nasal oxygen.

  This trial will test whether asking adults with community-acquired pneumonia who are on high-flow nasal oxygen to lie on their stomach while awake can reduce the need for a breathing tube.

  Recruiting at 11 sites University Hospital, Tours · Amiens and 37 other locations · NCT06966310

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.