Multicenter Phase Ⅱ Study of Silmitasertib (CX-4945) in Patients with CAP Associated with Viral Infections.
Study Focus
Multicenter Phase Ⅱ Study of Silmitasertib (CX-4945) in Patients with CAP Associated with Viral Infections.
Protocol Number
CX-4945-011
Sponsor
Senhwa
Estimated Enrollment
120 subjects (evaluable)
Objective
Primary Objective:
To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared to placebo plus SOC, in preventing the progression of CAP associated with SARS-CoV-2 and influenza virus infection
The percentage of subjects requiring hospitalization, including emergency room visits, due to progression of CAP related to SARS-CoV-2 or influenza
Secondary Objectives:
To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in enhancing the subject's clinical condition
The percentage of subjects with all cause hospitalization during study period
The percentage of subjects with improved pulmonary X-ray findings for pneumonia, relative to baseline or showing a return to normalcy
Time to symptom resolution for fever
Change from baseline in SpO2/FiO2 ratio ;
The percentage of subjects exhibiting disease progression in health status (evaluated using the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale/6-point ordinal scale)
The percentage of subjects exhibiting disease improvement in health status (evaluated using the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale/6-point ordinal scale)
To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, in reducing viral load.Change from baseline in viral load/Ct values in nasal secretions by qRT-PCR. (only for SARS-CoV-2 domain)
Time to FilmArray confirmed resolution of viral infection
To evaluate the safety and tolerability of Silmitasertib (CX-4945)TEAEs and SAEs
Exploratory Objective:
To evaluate the effect of intervention with Silmitasertib (CX-4945) in addition to SOC, compared with placebo plus SOC, on inflammatory status and on moderating the elevated cytokine release associated with SARS-CoV-2 and influenza virus infection
The percentage of subjects achieving normalized CRP levels.
Change from baseline in ferritin, C-reactive protein (CRP), CRP to albumin ratio (CAR), D-dimer, lactate dehydrogenase (LDH)...etc.
Changes from baseline in serum cytokine levels: Cytokines to be quantified; IL-6, IL-1β, tumor necrosis factor alpha (TNF-α)...etc.
