Phase 2 Study of SR1375 Capsules for Treatment of Adults Hospitalized with Community-acquired Pneumonia

What this Trial Is About

Researchers are studying the effects and safety of SR1375 in hospitalized adults with community-acquired pneumonia CAP. This phase 2, randomized, double-blind, placebo-controlled study aims to evaluate SR1375 compared to placebo in patients who have not improved after initial standard pneumonia treatment. The study includes adults aged 18 to 85 years and is sponsored by Shanghai SIMR Biotechnology Co., Ltd. Participants will be randomly assigned to one of four groups to receive either 0.3 mg, 1 mg, or 3 mg of SR1375 capsules or a placebo daily by mouth for 8 weeks, alongside their usual pneumonia treatments. The study includes a screening period, an 8-week double-blind treatment period, and a 14-day safety follow-up after treatment ends. During the study, participants will undergo assessments including the NIAID-OS 8-point scale to monitor pneumonia severity, oxygen levels, and other health measures up to 56 days. Researchers will track outcomes such as oxygenation, mortality, hospitalization duration, and readmission rates. The total participation time for each patient is up to 10 weeks, with close monitoring of safety and health status throughout the study.

Efficacy and Safety of SR1375 in Adult Patients With CAP