Efficacy and Safety of SR1375 in Adult Patients With CAP

Launched by SHANGHAI SIMR BIOTECHNOLOGY CO., LTD. · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SR1375 to see how well it works and how safe it is for adult patients who have community-acquired pneumonia (CAP). Community-acquired pneumonia is an infection in the lungs that people can get outside of a hospital setting. The trial will involve patients who are hospitalized and will last for up to 10 weeks, with participants receiving either SR1375 or a placebo (a treatment that looks the same but has no active medication) for 8 weeks.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with CAP. They should also have a specific level of oxygen saturation and at least one high-risk health condition such as chronic lung disease, diabetes, or being over 65 years old. During the trial, participants can expect regular check-ins to monitor their health and any side effects. It’s important to note that certain people, like those needing immediate invasive breathing support or those with specific severe health issues, will not be able to join the study. This trial is currently recruiting participants, and both men and women are welcome to apply.

Gender

ALL

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.