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A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of SR1375 in Hospitalized Patients with Pneumonia

A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of SR1375 in Hospitalized Patients With Pneumonia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067741
Enrollment
Unknown
Registered
2023-01-19
Start date
2023-01-19
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Interventions

Group 1:standard treatment + SR1375 3mg
Group 2:standard treatment + SR1375 10mg
Group 3:standard treatment + placebo

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The subject or his legal representative guardian is willing to participate in the study and sign the informed consent form; 2. Male or female, the age is >= 18 years old; 3. Patients who have been hospitalized or are scheduled to be hospitalized before enrollment during screening; 4. Those who meet the clinical diagnosis of any of the following pneumonia during screening: (1) Moderate or severe COVID-19 infection; (2) Community-acquired pneumonia; (3) Hospital-acquired pneumonia; 5. Female subjects and male subjects whose partners are childbearing potential (WOCBP) must agree to use one or more effective contraceptive methods during the whole study period to 30 days (female) or 90 days (male) after the last dose, and must not donate eggs or sperm; 6. WOCBP and blood ß-HCG of female subjects with natural menopause < 12 months must be negative.

Exclusion criteria

Exclusion criteria: 1. Have serious systemic diseases or clinical issues, are not suitable for participating in the study in the judgement of the investigator; 2. Have diseases that may seriously affect gastrointestinal absorption before screening; 3. Female subjects who are pregnant or lactating; 4. The laboratory test results of the subject are abnormal with clinical significance, and are suitable for participating the trial in the judgement of the investigator; 5. ECG value at screening shows the presence of clinically relevant abnormalities that may affect the safety of the subject or the judgment of the test results; 6. The subject was not suitable for the study in the judgement of the investigator.

Design outcomes

Secondary

MeasureTime frame
time to the need of high flow oxygen;time to noninvasive mechanical ventilation;time to invasive mechanical ventilation;time to use ECMO;death proportion;

Primary

MeasureTime frame
vital signs;physical examination;hematology;blood biochemistry;coagulation function;arterial blood gas analysis;urine analysis;Blood/urine ß-HCG was test;ECG;Adverse events;Serious Adverse events;concomitant medication;WHO 7 rating scale;

Countries

China

Contacts

Public ContactLi Weimin

West China Hospital, Sichuan University

Weimin003@163.com+86 28 8542 3998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026