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โ† Trials
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Efficacy and Safety of SR1375 in Adult Patients With CAP

RecruitingPhase 2Ages 18 Years - 85 YearsAllShanghai SIMR Biotechnology Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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. The study duration for each patient is up to 10 weeks.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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 โ‰ฅ 4 L/min.) * With โ‰ฅ 1 high risk factors including chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, type 2 diabetes, chronic kidney disease, coronary heart disease, age โ‰ฅ 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 mยฒ (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 ฮฒ-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.
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What it tests

  • SR1375 capsule 3mg+regular treatments
  • SR1375 capsule 1mg+regular treatments
  • SR1375 capsule 0.3mg+regular treatments
  • Placebo capsule+regular treatments
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Where

29 sites
Fuyang People's Hospital
Fuyang, China
Peking University Third Hospital
Beijing, China
Zhangzhou Hospital
Zhangzhou, China
Gaozhou People's Hospital
Gaozhou, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, China
Nanfang Hospital
Guangzhou, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, China

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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