Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SR1375 in Hospitalized Adult Patients With Community-acquired Pneumonia
Led by Shanghai SIMR Biotechnology Co., Ltd. · Updated on 2025-07-09
240
Participants Needed
29
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects and safety of SR1375 in hospitalized adults with community-acquired pneumonia (CAP). This phase 2, randomized, double-blind, placebo-controlled study aims to evaluate SR1375 compared to placebo in patients who have not improved after initial standard pneumonia treatment. The study includes adults aged 18 to 85 years and is sponsored by Shanghai SIMR Biotechnology Co., Ltd. Participants will be randomly assigned to one of four groups to receive either 0.3 mg, 1 mg, or 3 mg of SR1375 capsules or a placebo daily by mouth for 8 weeks, alongside their usual pneumonia treatments. The study includes a screening period, an 8-week double-blind treatment period, and a 14-day safety follow-up after treatment ends. During the study, participants will undergo assessments including the NIAID-OS 8-point scale to monitor pneumonia severity, oxygen levels, and other health measures up to 56 days. Researchers will track outcomes such as oxygenation, mortality, hospitalization duration, and readmission rates. The total participation time for each patient is up to 10 weeks, with close monitoring of safety and health status throughout the study.
CONDITIONS
Brief Title
Efficacy and Safety of SR1375 in Adult Patients With CAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by the participant or legally acceptable representative
- Aged 18 to 85 years
- Diagnosed with community-acquired pneumonia
- Received at least 3 days of intravenous antibiotic treatment for pneumonia without clinical improvement
- Chest CT showing multi-lobar infiltrates and, if not on invasive mechanical ventilation, an oxygenation index between 100 and 300 mmHg
- Expected to require hospitalization for at least 7 days after consent
- Baseline NIAID-OS 8-point scale score of 5, 6, or 7 points with specified oxygen saturation levels
- Have 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
- Women of childbearing potential and men with such partners must 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 treatment within 24 hours
- Active tuberculosis or severe asthma
- History of unstable angina or heart attack within 3 months, or stroke within 4 weeks prior to screening
- Recent chemotherapy or immunotherapy within 4 weeks, or active hematological malignancy or lung tumor causing obstructive pneumonia
- Any disease expected to cause death within 12 weeks after randomization
- Prior use of JAK inhibitors, interleukin receptor inhibitors, or investigational drugs within a specified washout period
- Liver enzymes ALT or AST more than 3 times the upper limit of normal
- Severe kidney impairment with eGFR below 30 mL/min/1.73 m² unless assessed suitable by investigator
- Significant ECG abnormalities that affect safety
- Pregnant or lactating women or positive pregnancy test
- Any severe systemic disease or condition making participation unsuitable according to investigator judgment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 56 days
Participants receive daily oral study medication (SR1375 or placebo) along with regular treatments for community-acquired pneumonia.
Daily medication with regular clinical assessments during treatment
Duration - 14 days
Participants complete a safety follow-up period after treatment ends to monitor health and safety outcomes.
Follow-up visits for safety monitoring
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
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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