Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19
This is a Phase 2, open-label, randomized 2-arm multicenter study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) administered orally plus Standard of Care (SOC) versus SOC in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 infection and COVID-19 pneumonia (documented radiographically). Only hospitalized patients are eligible for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.
Standard of Care as determined by the Investigator
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Teradan Clinical Trials
Brandon, Florida, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States
Clinical Trials of SWLA
Lake Charles, Louisiana, United States
Percentage of Subjects Alive and Free of Respiratory Failure at Day 28
Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities: * Noninvasive positive pressure ventilation or continuous positive airway pressure * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥ 0.5) * Extracorporeal membrane oxygenation
Time frame: Randomization to Day 28
Number of Participants With Treatment-emergent Adverse Events
Number of Participants with Treatment-emergent Adverse Events
Time frame: Randomization through study completion to 94 days
Percentage of Subjects Alive and Free of Respiratory Failure at Day 60
Percentage of subjects alive and free of respiratory failure at Day 60
Time frame: Randomization to Day 60
Change in C-Reactive Protein (CRP)
Mean change in CRP on Day 7
Time frame: Day 7
Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)
PaO2/FiO2 at Day 1
Time frame: Day 1
All-cause Mortality at Day 60 and Day 90
All-cause mortality at Day 60 and Day 90
Time frame: Day 60 and Day 90
Number of Days Alive Outside of Hospital up to Day 28
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Quality Clinical Research
Omaha, Nebraska, United States
Memorial Hermann Memorial City Hospital
Houston, Texas, United States
Number of days alive outside of hospital up to Day 28
Time frame: Randomization up to Day 28