Clinical trial NCT06577558: Efficacy and Safety of SR1375 in Adult Patients With CAP
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Community-acquired Pneumonia
Keywords: Community acquired Pneumonia
SR1375
Lead sponsor: Shanghai SIMR Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
timeFrame: Up to Day 28
Secondary outcomes:
measure: Proportion of subjects ≥ 2 points improvement in National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
timeFrame: Up to Day 28
measure: National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
timeFrame: Up to Day 14
measure: All-cause mortality rate
timeFrame: Up to Day 56
measure: Proportion of subjects with invasive mechanical ventilation, Extracorporeal Membrane Oxygenation(ECMO) or all-cause death.
timeFrame: Up to Day 56
measure: Partial Pressure of Oxygen(PaO2)/Fraction of Inspiration Oxygen(FiO2)
timeFrame: Up to Day 28
measure: Proportion of subjects admitted in ICU or all-cause death
timeFrame: Up to Day 56
measure: Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale
timeFrame: Up to Day 56
measure: Survival days without invasive mechanical ventilation or ECMO
timeFrame: Up to Day 56
measure: Survival days without ICU admission
timeFrame: Up to Day 56
measure: Days of hospitalization
timeFrame: Up to Day 56
measure: All-cause readmission rate
timeFrame: Up to Day 56
measure: Readmission rate due to pneumonia
timeFrame: Up to Day 56
Other outcomes:
measure: The item short from health survey (SF-36) score
timeFrame: Up to Day 56
measure: Adverse events and serious adverse events
timeFrame: Up to Day 70
measure: Pharmacokinetic (PK) parameter Cmax
timeFrame: Up to Day 56
measure: PK parameter Tmax
timeFrame: Up to Day 56
measure: PK parameter AUC0-t
timeFrame: Up to Day 56
measure: PK parameter t1/2
timeFrame: Up to Day 56
measure: PK parameter Vd/F
timeFrame: Up to Day 56
measure: Pharmacodynamic (PD) parameter lipoprotein associated phospholipase A2 (Lp-PLA2) activity
timeFrame: Up to Day 56
Locations:
city: Fuyang
country: China
facility: Fuyang People's Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Zhangzhou
country: China
facility: Zhangzhou Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Yulin
country: China
facility: Yulin First People's Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Daqing
country: China
facility: Daqing People's Hospital
state: Heilongjiang
city: Shangqiu
country: China
facility: Shangqiu People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Yueyang
country: China
facility: Yueyang Central Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yanbian
country: China
facility: Yanbian University Affiliated Hospital
state: Jilin
city: Dalian
country: China
facility: Dalian Central Hospital
state: Liaoning
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Weifang
country: China
facility: Weifang Second People's Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: The First Affiliated Hospital of Chengdu Medical College
state: Sichuan
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
Study officials:
affiliation: West China Hospital
name: Weimin Li, MD
role: PRINCIPAL_INVESTIGATOR
References: