Efficacy and Safety of SR1375 in Adult Patients With CAP
ConditionCommunity-acquired Pneumonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai SIMR Biotechnology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
SR1375 capsule 3mg+regular treatments
DrugSR1375 capsule 3mg QD orally+CAP regular treatments
SR1375 capsule 1mg+regular treatments
DrugSR1375 capsule 1mg QD orally+CAP regular treatments
SR1375 capsule 0.3mg+regular treatments
DrugSR1375 capsule 0.3mg QD orally+CAP regular treatments
Placebo capsule+regular treatments
DrugPlacebo capsule QD orally+CAP regular treatments
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: SR1375 capsule 3mgExperimental treatment 1 intervention
Group B: SR1375 capsule 1mgExperimental treatment 1 intervention
Group C: SR1375 capsule 0.3mgExperimental treatment 1 intervention
Group D: placebo capsulePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 28Secondary outcomes
1
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 282
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 143
All-cause mortality rate
The all-cause mortality rate at Day 28 and Day 56
Time frame
Up to Day 564
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 56Other outcomes
1
The item short from health survey (SF-36) score
Change from baseline to Day 28 and Day 56 in SF-36 score. SF-36 scores range from 0 to 100 and the higher score means the better condition.
Time frame
Up to Day 562
Adverse events and serious adverse events
AE and SAE occurence and severity during the study
Time frame
Up to Day 703
Pharmacokinetic (PK) parameter Cmax
Maximum plasma concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Time frame
Up to Day 564
PK parameter Tmax
Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) .
Time frame
Up to Day 56Sponsors and contacts
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Source ClinicalTrials.gov