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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
SR1375 capsule 3mg QD orally+CAP regular treatments
SR1375 capsule 1mg QD orally+CAP regular treatments
SR1375 capsule 0.3mg QD orally+CAP regular treatments
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.
Time frame: Up to Day 28
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
Time frame: Up to Day 28
National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
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.
Time frame: Up to Day 14
All-cause mortality rate
The all-cause mortality rate at Day 28 and Day 56
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 28
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Placebo capsule QD orally+CAP regular treatments
Fuyang People's Hospital
Fuyang, Anhui, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGZhangzhou Hospital
Zhangzhou, Fujian, China
RECRUITINGGaozhou People's Hospital
Gaozhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGNanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
RECRUITINGYulin First People's Hospital
Yulin, Guangxi, China
RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITING...and 19 more locations
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
Time frame: 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
Time frame: 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.
Time frame: Up to Day 56
Survival days without ICU admission
Survival days without ICU admission within 28 and 56 days
Time frame: Up to Day 56
Days of hospitalization
Days of hospitalization within 28 and 56 days
Time frame: Up to Day 56
All-cause readmission rate
All-cause readmission rate within 56 days
Time frame: Up to Day 56
Readmission rate due to pneumonia
Readmission rate due to pneumonia within 56 days
Time frame: Up to Day 56