Community-acquired PneumoniaPhase 2CAPNCT06577558
Efficacy and Safety of SR1375 in Adult Patients With CAP
A Phase 2 study testing SR1375 capsule 3mg+regular treatments, SR1375 capsule 1mg+regular treatments and SR1375 capsule 0.3mg+regular treatments in people with Community-acquired Pneumonia, run by Shanghai SIMR Biotechnology Co., Ltd. at 29 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- SR1375 capsule 3mg+regular treatments, SR1375 capsule 1mg+regular treatments and SR1375 capsule 0.3mg+regular treatments
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 29 sitesChina
- Study dates
- 10 Sep 2024to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject or their legally acceptable representative (LAR) has voluntarily signed the informed consent form (ICF) prior to any study-related procedures, and the subject is willing and able to comply with all study requirements, restrictions, and procedures. If consent is provided by an LAR for a subject with limited or no capacity to consent, re-consenting may be performed if the subject regains capacity.
- Aged 18 to 85 years.
- Diagnosis of CAP
- Prior to screening, the subject has been receiving standard-of-care treatment for pneumonia in a medical institution, including at least 3 days of intravenous (IV) anti-infective therapy, with no clinical improvement.
- Chest CT showing multi-lobar infiltrates, and for subjects not receiving invasive mechanical ventilation, an oxygenation index (PaO2/FiO2 ratio) between 100 and 300 mmHg.
- Expected to require continued hospitalization for at least 7 days from the time of signing the ICF.
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- Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygen saturation ≤ 93% without oxygen inhalation, 6 points or 7points. (5 points refer to hospitalization with oxygen therapy; 6 points refer to hospitalization with high flow oxygen therapy or non-invasive mechanical ventilation. 7 points refer to hospitalization with 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.
Who cannot join
- Patients who are currently receiving or are expected to require ECMO treatment within 24 hours.
- Presence of active tuberculosis (TB) or severe asthma.
- History of unstable angina or acute myocardial infarction within 3 months prior to screening, or stroke within 4 weeks prior to screening.
- Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeks prior to randomization, or are planned to receive such treatment during the study period; presence of a hematological malignancy not in complete remission; or a lung tumor with concurrent obstructive pneumonia.
- Presence of any concomitant disease that is expected to result in death within 12 weeks after randomization.
- Prior use of JAK inhibitors (e.g., Baricitinib), interleukin receptor inhibitors (e.g., Tocilizumab), or any investigational drug in another clinical trial, where the last dose was administered less than 5 half-lives before the first dose of the study drug in this trial.
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- ALT) or AST > 3 times the upper limit of normal (ULN).
- eGFR < 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula); however, patients undergoing dialysis may be included upon the investigator's assessment of their suitability for the trial.
- Presence of clinically significant abnormalities on ECG that may seriously affect subject safety, e.g., QTcF > 480 ms.
- Female subjects who are pregnant, lactating, or have a positive serum β-HCG pregnancy test.
- Presence of any severe systemic disease or clinical condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
China29 sites, 27 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Dan Liu, Doctor
- Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610500
- Recruiting
Dalian Central Hospital
Dalian, Liaoning, 116021
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116021
- Recruiting
Daqing Longnan Hospital
Daqing, Heilongjiang, 163000
- Recruiting
Daqing People's Hospital
Daqing, Heilongjiang, 163000
- Recruiting
Fuyang People's Hospital
Fuyang, Anhui, 236001
- Recruiting
Gaozhou People's Hospital
Gaozhou, Guangdong, 525200
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
- Recruiting
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510630
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 515399
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang, 323000
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
- Withdrawn
Nanjing First Hospital
Nanjing, Jiangsu, 210006
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
- Recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200335
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
- Recruiting
Shangqiu People's Hospital
Shangqiu, Henan, 476100
- Recruiting
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050023
- Recruiting
Weifang Second People's Hospital
Weifang, Shandong, 261041
- Withdrawn
Yanbian University Affiliated Hospital
Yanbian, Jilin, 133000
- Recruiting
Yueyang Central Hospital
Yueyang, Hunan, 414000
- Recruiting
Yulin First People's Hospital
Yulin, Guangxi, 537000
- Recruiting
Zhangzhou Hospital
Zhangzhou, Fujian, 363000
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
- Recruiting
Zibo Municipal Hospital
Zibo, Shandong, 255100
About this study
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
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.
Read the 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- SR1375 capsule 3mg+regular treatments, SR1375 capsule 1mg+regular treatments, SR1375 capsule 0.3mg+regular treatments, Placebo capsule+regular treatments
- Keywords
- Community acquired Pneumonia, SR1375
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR1375 capsule 3mg+regular treatmentsDrug
Also called SR1375 capsule high dose+regular treatments
SR1375 capsule 3mg QD orally+CAP regular treatments
SR1375 capsule 1mg+regular treatmentsDrug
Also called SR1375 capsule medium dose+regular treatments
SR1375 capsule 1mg QD orally+CAP regular treatments
SR1375 capsule 0.3mg+regular treatmentsDrug
Also called SR1375 capsule low dose+regular treatments
SR1375 capsule 0.3mg QD orally+CAP regular treatments
Placebo capsule+regular treatmentsDrug
Placebo capsule QD orally+CAP regular treatments
| Study group | Role | What they receive |
|---|---|---|
| SR1375 capsule 3mg | Experimental | SR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks Receives: Drug: SR1375 capsule 3mg+regular treatments |
| SR1375 capsule 1mg | Experimental | SR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks Receives: Drug: SR1375 capsule 1mg+regular treatments |
| SR1375 capsule 0.3mg | Experimental | SR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks Receives: Drug: SR1375 capsule 0.3mg+regular treatments |
| placebo capsule | Placebo comparator | Placebo capsule QD orally with CAP regular treatments for 8 weeks Receives: Drug: Placebo capsule+regular treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 28
Secondary outcomes (12)
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
Measured: 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.
Measured: Up to Day 14
All-cause mortality rate
The all-cause mortality rate at Day 28 and Day 56
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to Day 56
Survival days without ICU admission
Survival days without ICU admission within 28 and 56 days
Measured: Up to Day 56
Days of hospitalization
Days of hospitalization within 28 and 56 days
Measured: Up to Day 56
All-cause readmission rate
All-cause readmission rate within 56 days
Measured: Up to Day 56
Readmission rate due to pneumonia
Readmission rate due to pneumonia within 56 days
Measured: Up to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start10 Sep 2024
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weimin Li, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577558
- Sponsor's protocol ID
- SR1375-204
- Acronym
- CAP
- Status last verified
- Jul 2025
- First submitted
- 19 Aug 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06577558
- Acronym / sponsor ID
- CAP / SR1375-204
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community acquired Pneumonia, SR1375
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SR1375 capsule 3mg | Experimental | Drug: SR1375 capsule 3mg+regular treatmentsSR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks |
| SR1375 capsule 1mg | Experimental | Drug: SR1375 capsule 1mg+regular treatmentsSR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks |
| SR1375 capsule 0.3mg | Experimental | Drug: SR1375 capsule 0.3mg+regular treatmentsSR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks |
| placebo capsule | Placebo comparator | Drug: Placebo capsule+regular treatmentsPlacebo capsule QD orally with CAP regular treatments for 8 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject or their legally acceptable representative (LAR) has voluntarily signed the informed consent form (ICF) prior to any study-related procedures, and the subject is willing and able to comply with all study requirements, restrictions, and procedures. If consent is provided by an LAR for a subject with limited or no capacity to consent, re-consenting may be performed if the subject regains capacity.
- Aged 18 to 85 years.
- Diagnosis of CAP
- Prior to screening, the subject has been receiving standard-of-care treatment for pneumonia in a medical institution, including at least 3 days of intravenous (IV) anti-infective therapy, with no clinical improvement.
- Chest CT showing multi-lobar infiltrates, and for subjects not receiving invasive mechanical ventilation, an oxygenation index (PaO2/FiO2 ratio) between 100 and 300 mmHg.
Key exclusion criteria (11 listed)
- Patients who are currently receiving or are expected to require ECMO treatment within 24 hours.
- Presence of active tuberculosis (TB) or severe asthma.
- History of unstable angina or acute myocardial infarction within 3 months prior to screening, or stroke within 4 weeks prior to screening.
- Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeks prior to randomization, or are planned to receive such treatment during the study period; presence of a hematological malignancy not in complete remission; or a lung tumor with concurrent obstructive pneumonia.
- Presence of any concomitant disease that is expected to result in death within 12 weeks after randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR1375 capsule 3mg+regular treatmentsAlso: SR1375 capsule high dose+regular treatmentsSR1375 capsule 3mg QD orally+CAP regular treatments | Drug | SR1375 capsule 3mg |
| SR1375 capsule 1mg+regular treatmentsAlso: SR1375 capsule medium dose+regular treatmentsSR1375 capsule 1mg QD orally+CAP regular treatments | Drug | SR1375 capsule 1mg |
| SR1375 capsule 0.3mg+regular treatmentsAlso: SR1375 capsule low dose+regular treatmentsSR1375 capsule 0.3mg QD orally+CAP regular treatments | Drug | SR1375 capsule 0.3mg |
| Placebo capsule+regular treatmentsPlacebo capsule QD orally+CAP regular treatments | Drug | placebo capsule |
Primary outcome
National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
Time frame: 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.
12 secondary outcomes
Proportion of subjects ≥ 2 points improvement in National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
Time frame: Up to Day 28
National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
Time frame: Up to Day 14
All-cause mortality rate
Time frame: Up to Day 56
Proportion of subjects with invasive mechanical ventilation, Extracorporeal Membrane Oxygenation(ECMO) or all-cause death.
Time frame: Up to Day 56
Partial Pressure of Oxygen(PaO2)/Fraction of Inspiration Oxygen(FiO2)
Time frame: Up to Day 28
Proportion of subjects admitted in ICU or all-cause death
Time frame: Up to Day 56
Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale
Time frame: Up to Day 56
Survival days without invasive mechanical ventilation or ECMO
Time frame: Up to Day 56
Survival days without ICU admission
Time frame: Up to Day 56
Days of hospitalization
Time frame: Up to Day 56
All-cause readmission rate
Time frame: Up to Day 56
Readmission rate due to pneumonia
Time frame: Up to Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weimin Li, MD principal investigator
West China Hospital
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR1375 capsule 3mg+regular treatments, SR1375 capsule 1mg+regular treatments and SR1375 capsule 0.3mg+regular treatments in people with Community-acquired Pneumonia, run by Shanghai SIMR Biotechnology Co., Ltd. at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang, PhD ((086)021-68161783, fwang@simrbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.