Taiwan Phase II Study of Silmitasertib (CX-4945) in Hospitalized Adults with COVID-19
Study Focus
Taiwan Phase II Study of Silmitasertib (CX-4945) in Hospitalized Adults with COVID-19
Protocol Number
CX-4945-AV06-phase II
Requestor
Senhwa Biosciences, Inc.
Estimated Enrollment
40 patients
Objective
Primary Objective:
To evaluate the safety and tolerability of CX-4945 in adult COVID-19 patients hospitalized with positive SARS-CoV-2
Safety variables include but are not limited to vital assessment, physical examinations, clinical laboratory assessments (hematology, biochemistry, coagulation, urinalysis, etc.), 12-lead electrocardiogram (ECG), chest X-ray (CXR), and adverse events (AEs) by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
The proportion of subjects with treatment-emergent AEs (TEAEs) leading to study drug discontinuation.
Secondary Objectives:
To evaluate the efficacy of CX-4945 in adult COVID-19 patients hospitalized with positive SARS-CoV-2
Baseline change in the World Health Organization (WHO) Ordinal Scale on Days 2, 3, 4, 5, 7, 14, 30 and discharge day when applicable.
Time to COVID-19 clinical improvement on Days 2, 3, 4, 5, 7, 14, 30, and discharge day when applicable. Clinical improvement is defined as a positive baseline change in the WHO Ordinal Scale by 2 points or higher.
Baseline change in the cycle threshold (Ct) values in SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) testing on Days 3, 5, 14, 30, and discharge day when applicable.
Time to SARS-CoV-2 clearance, defined by time from randomization to the first 2 consecutive negative RT-PCR test results (sampling interval ≥24 hours).
Percentage of subjects requiring critical care unit admission within 30 days.
Proportion of subjects alive and free of respiratory failure, determined by the Investigator, on Day 30.
Exploratory endpoints:
Baseline change in ferritin, C-reactive protein (CRP), D-dimer, lactate dehydrogenase (LDH), neutrophil to lymphocyte ratio (NLR), neutrophil to CD4+ T lymphocyte ratio (N4R), neutrophil to CD3+ T lymphocyte ratio (N3R), granulocyte colony-stimulating factor (G-CSF), and granulocyte-macrophage colony-stimulating factor (GM-CSF) on Days 3, 5, 7, 14 and 30.
Baseline change in IL-1b, IL-2, IL-6, IL-7, IL-8, IL-10, IL-18, monocyte chemoattractant protein-1 (MCP-1), plasminogen activator inhibitor-1 (PAI-1) on Days 3, 5, 7, 14 and 30.
