Efficacy and Safety of SR1375 in Adult Patients With CAP
- Conditions
- Community-acquired Pneumonia
- Interventions
- Drug: SR1375 capsule 3mg+regular treatmentsDrug: SR1375 capsule 1mg+regular treatmentsDrug: SR1375 capsule 0.3mg+regular treatmentsDrug: Placebo capsule+regular treatments
- Registration Number
- NCT06577558
- Lead Sponsor
- Shanghai SIMR Biotechnology Co., Ltd.
- Brief Summary
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.
- Detailed Description
This is a randomized, double-blind and placebo-controlled phase 2 study comparing SR1375 with placebo in adult patients with CAP. It consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. Baseline NIAID-OS 8-point scale score will be checked for eligibility. Around 240 eligible subjects will be recruited and randomized into four arms at 1:1:1:1 ratio to receive SR1375 0.3mg, SR1375 1mg, SR1375 3mg or placebo orally daily for 56 days. Subjects, investigators, all clinical study site staffs, and the Sponsor will remain blinded to treatment assignment during the study. Subjects will receive regular treatments as per his/her condition by investigator. After completion of double-blind treatment period, subjects will continue to complete the safety follow-up for 14 days.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- Age ≥ 18 years, male or female
- Diagnosis of CAP
- Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygen saturation ≤ 93% without oxygen inhalation or 6 points. (5 points refer to hospitalization with oxygen therapy; 6 points refer to hospitalization with high flow oxygen therapy or non-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
- Have received or require invasive mechanical ventilation or ECMO within 24 hours.
- With septic shock requiring vasoactive drugs.
- Unable to swallow capsules due to consciousness disorders or other reasons.
- With active tuberculosis, severe asthma, hyperglycemia, hyperosmolality, ketoacidosis or diabetes foot.
- Have experienced unstable angina, acute myocardial infarction, or stroke within the past 3 months.
- Have taken glucocorticoids with an average daily dose >40 mg methylprednisolone or equivalent dose within the past 3 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SR1375 capsule 3mg SR1375 capsule 3mg+regular treatments SR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks SR1375 capsule 1mg SR1375 capsule 1mg+regular treatments SR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks SR1375 capsule 0.3mg SR1375 capsule 0.3mg+regular treatments SR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks placebo capsule Placebo capsule+regular treatments Placebo capsule QD orally with CAP regular treatments for 8 weeks
- Primary Outcome Measures
Name Time Method National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score Up to Day 28 Change from baseline to Day 28 in NIAID-OS 8 scale score. NIAID-OS 8 scale ranges from 1 point (no hospitalization, no activity restrictions) to 8 points (death). The higher score means the worse outcome.
- Secondary Outcome Measures
Name Time Method Proportion of subjects ≥ 2 points improvement in National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score Up to Day 28 Subject proportion of ≥ 2 points improvement in NIAID-OS 8-point scale at Day 14 and Day 28
National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score Up to Day 14 Change from baseline to Day 7 and Day 14 in NIAID-OS 8 scale score. NIAID-OS 8 scale ranges from 1 point (no hospitalization, no activity restrictions) to 8 points(death)，the higher score means the worse outcome.
All-cause mortality rate Up to Day 56 The all-cause mortality rate at Day 28 and Day 56
Proportion of subjects with invasive mechanical ventilation, Extracorporeal Membrane Oxygenation(ECMO) or all-cause death. Up to Day 56 Subjects proportions with invasive mechanical ventilation, ECMO or all-cause death at Day 28 and Day 56.
Partial Pressure of Oxygen(PaO2)/Fraction of Inspiration Oxygen(FiO2) Up to Day 28 Change from baseline to Day 7 and Day 28 in PaO2/FiO2.
Proportion of subjects admitted in ICU or all-cause death Up to Day 56 Proportion of subjects admitted in ICU or all-cause death at Day 28 and Day 56
Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale Up to Day 56 Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale at Day 28 and Day 56
Survival days without invasive mechanical ventilation or ECMO Up to Day 56 Survival days without invasive mechanical ventilation or ECMO within 28 and 56 days.
Survival days without ICU admission Up to Day 56 Survival days without ICU admission within 28 and 56 days
Days of hospitalization Up to Day 56 Days of hospitalization within 28 and 56 days
All-cause readmission rate Up to Day 56 All-cause readmission rate within 56 days
Readmission rate due to pneumonia Up to Day 56 Readmission rate due to pneumonia within 56 days
Trial Locations
- Locations (26)
Fuyang People's Hospital
🇨🇳Fuyang, Anhui, China
Zhangzhou Hospital
🇨🇳Zhangzhou, Fujian, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Yulin First People's Hospital
🇨🇳Yulin, Guangxi, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Daqing People's Hospital
🇨🇳Daqing, Heilongjiang, China
Shangqiu People's Hospital
🇨🇳Shangqiu, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Yueyang Central Hospital
🇨🇳Yueyang, Hunan, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Yanbian University Affiliated Hospital
🇨🇳Yanbian, Jilin, China
Dalian Central Hospital
🇨🇳Dalian, Liaoning, China
Weifang Second People's Hospital
🇨🇳Weifang, Shandong, China
Zibo Municipal Hospital
🇨🇳Zibo, Shandong, China
Shanghai Tongren Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Chengdu Medical College
🇨🇳Chengdu, Sichuan, China
Lishui Central Hospital
🇨🇳Lishui, Zhejiang, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China