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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR1375 capsule 3mg | Experimental | SR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks |
|
| SR1375 capsule 1mg | Experimental | SR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks |
|
| SR1375 capsule 0.3mg | Experimental | SR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks |
|
| placebo capsule | Placebo Comparator | Placebo capsule QD orally with CAP regular treatments for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR1375 capsule 3mg+regular treatments | Drug | SR1375 capsule 3mg QD orally+CAP regular treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score | 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. | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects ≥ 2 points improvement in National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score | Subject proportion of ≥ 2 points improvement in NIAID-OS 8-point scale at Day 14 and Day 28 | Up to Day 28 |
| National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score |
| Measure | Description | Time Frame |
|---|---|---|
| The item short from health survey (SF-36) score | Change from baseline to Day 28 and Day 56 in SF-36 score. SF-36 scores range from 0 to 100 and the higher score means the better condition. | Up to Day 56 |
| Adverse events and serious adverse events |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang, PhD | Contact | (086)021-68161783 | fwang@simrbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Weimin Li, MD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang People's Hospital | Recruiting | Fuyang | Anhui | 236001 | China | |
| Peking University Third Hospital |
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| SR1375 capsule 1mg+regular treatments | Drug | SR1375 capsule 1mg QD orally+CAP regular treatments |
|
|
| SR1375 capsule 0.3mg+regular treatments | Drug | SR1375 capsule 0.3mg QD orally+CAP regular treatments |
|
|
| Placebo capsule+regular treatments | Drug | Placebo capsule QD orally+CAP regular treatments |
|
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. |
| Up to Day 14 |
| All-cause mortality rate | The all-cause mortality rate at Day 28 and Day 56 | Up to Day 56 |
| Proportion of subjects with invasive mechanical ventilation, Extracorporeal Membrane Oxygenation(ECMO) or all-cause death. | Subjects proportions with invasive mechanical ventilation, ECMO or all-cause death at Day 28 and Day 56. | Up to Day 56 |
| Partial Pressure of Oxygen(PaO2)/Fraction of Inspiration Oxygen(FiO2) | Change from baseline to Day 7 and Day 28 in PaO2/FiO2. | Up to Day 28 |
| Proportion of subjects admitted in ICU or all-cause death | Proportion of subjects admitted in ICU or all-cause death at Day 28 and Day 56 | Up to Day 56 |
| Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale | Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale at Day 28 and Day 56 | Up to Day 56 |
| Survival days without invasive mechanical ventilation or ECMO | Survival days without invasive mechanical ventilation or ECMO within 28 and 56 days. | Up to Day 56 |
| Survival days without ICU admission | Survival days without ICU admission within 28 and 56 days | Up to Day 56 |
| Days of hospitalization | Days of hospitalization within 28 and 56 days | Up to Day 56 |
| All-cause readmission rate | All-cause readmission rate within 56 days | Up to Day 56 |
| Readmission rate due to pneumonia | Readmission rate due to pneumonia within 56 days | Up to Day 56 |
AE and SAE occurence and severity during the study
| Up to Day 70 |
| Pharmacokinetic (PK) parameter Cmax | Maximum plasma concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | Up to Day 56 |
| PK parameter Tmax | Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) . | Up to Day 56 |
| PK parameter AUC0-t | Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | Up to Day 56 |
| PK parameter t1/2 | Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | Up to Day 56 |
| PK parameter Vd/F | Apparent volume of distribution (Vd/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | Up to Day 56 |
| Pharmacodynamic (PD) parameter lipoprotein associated phospholipase A2 (Lp-PLA2) activity | PD parameter Lp-PLA2 activity will be tested in central laboratory. | Up to Day 56 |
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Zhangzhou Hospital | Recruiting | Zhangzhou | Fujian | 363000 | China |
| Gaozhou People's Hospital | Recruiting | Gaozhou | Guangdong | 525200 | China |
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
| The Third Affiliated Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510630 | China |
| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | 515399 | China |
| The First Affiliated Hospital of Shantou University Medical College | Recruiting | Shantou | Guangdong | 515041 | China |
| Yulin First People's Hospital | Recruiting | Yulin | Guangxi | 537000 | China |
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050023 | China |
| Daqing Longnan Hospital | Recruiting | Daqing | Heilongjiang | 163000 | China |
| Daqing People's Hospital | Recruiting | Daqing | Heilongjiang | 163000 | China |
| Shangqiu People's Hospital | Recruiting | Shangqiu | Henan | 476100 | China |
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
| Yueyang Central Hospital | Recruiting | Yueyang | Hunan | 414000 | China |
| Nanjing First Hospital | Withdrawn | Nanjing | Jiangsu | 210006 | China |
| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | Jiangxi | 330006 | China |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
| Yanbian University Affiliated Hospital | Withdrawn | Yanbian | Jilin | 133000 | China |
| Dalian Central Hospital | Recruiting | Dalian | Liaoning | 116021 | China |
| The Second Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116021 | China |
| Weifang Second People's Hospital | Recruiting | Weifang | Shandong | 261041 | China |
| Zibo Municipal Hospital | Recruiting | Zibo | Shandong | 255100 | China |
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Tongren Hospital | Recruiting | Shanghai | Shanghai Municipality | 200335 | China |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| The First Affiliated Hospital of Chengdu Medical College | Recruiting | Chengdu | Sichuan | 610500 | China |
| Lishui Central Hospital | Recruiting | Lishui | Zhejiang | 323000 | China |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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