Actively Recruiting
Efficacy and Safety of SR1375 in Adult Patients With CAP
Led by Shanghai SIMR Biotechnology Co., Ltd. · Updated on 2025-07-09
240
Participants Needed
29
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of SR1375 in Adult Patients With CAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legally acceptable representative has signed informed consent and agrees to comply with study requirements
- Age between 18 and 85 years
- Diagnosis of community-acquired pneumonia (CAP)
- Receiving standard pneumonia treatment including at least 3 days of intravenous anti-infective therapy without clinical improvement
- Chest CT shows multi-lobar infiltrates
- For those not on invasive mechanical ventilation, oxygenation index (PaO2/FiO2) between 100 and 300 mmHg
- Expected to need hospitalization for at least 7 days from consent
- Baseline NIAID-OS 8-point scale score of 5, 6, or 7 points with specific oxygen saturation criteria
- At least one high-risk factor such as COPD, pulmonary fibrosis, type 2 diabetes, chronic kidney disease, coronary heart disease, age 65 or older, or moderate obesity (BMI >32.5)
- Women of childbearing potential and male partners agree to use effective contraception during treatment and for 90 days after last dose
You will not qualify if you...
- Currently receiving or expected to require ECMO within 24 hours
- Active tuberculosis or severe asthma
- Unstable angina or heart attack within 3 months, or stroke within 4 weeks prior to screening
- Recent chemotherapy or immunotherapy for cancer within 4 weeks, or ongoing hematological malignancy not in remission
- Any disease expected to cause death within 12 weeks after randomization
- Prior use of JAK inhibitors, interleukin receptor inhibitors, or investigational drugs within 5 half-lives before study drug
- ALT or AST liver enzymes more than 3 times normal
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 unless on dialysis and deemed suitable
- Significant ECG abnormalities affecting safety (e.g., QTcF > 480 ms)
- Pregnant, lactating, or positive pregnancy test
- Severe systemic diseases or conditions making participation unsuitable according to investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Fuyang People's Hospital
Fuyang, Anhui, China, 236001
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
3
Zhangzhou Hospital
Zhangzhou, Fujian, China, 363000
Actively Recruiting
4
Gaozhou People's Hospital
Gaozhou, Guangdong, China, 525200
Actively Recruiting
5
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
6
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
7
Nanfang Hospital
Guangzhou, Guangdong, China, 515399
Actively Recruiting
8
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515041
Actively Recruiting
9
Yulin First People's Hospital
Yulin, Guangxi, China, 537000
Actively Recruiting
10
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050023
Actively Recruiting
11
Daqing Longnan Hospital
Daqing, Heilongjiang, China, 163000
Actively Recruiting
12
Daqing People's Hospital
Daqing, Heilongjiang, China, 163000
Actively Recruiting
13
Shangqiu People's Hospital
Shangqiu, Henan, China, 476100
Actively Recruiting
14
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
15
Yueyang Central Hospital
Yueyang, Hunan, China, 414000
Actively Recruiting
16
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Withdrawn
17
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Actively Recruiting
18
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
19
Yanbian University Affiliated Hospital
Yanbian, Jilin, China, 133000
Withdrawn
20
Dalian Central Hospital
Dalian, Liaoning, China, 116021
Actively Recruiting
21
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China, 116021
Actively Recruiting
22
Weifang Second People's Hospital
Weifang, Shandong, China, 261041
Actively Recruiting
23
Zibo Municipal Hospital
Zibo, Shandong, China, 255100
Actively Recruiting
24
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
25
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China, 200335
Actively Recruiting
26
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
27
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
28
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, China, 610500
Actively Recruiting
29
Lishui Central Hospital
Lishui, Zhejiang, China, 323000
Actively Recruiting
Research Team
W
Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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