Study of the Efficacy and Safety of STI-5656 (Abivertinib... | NCT04440007

NCT04440007

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abivertinib with Standard of Care	Experimental	STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care	Drug: Abivertinib Other: Standard of Care
Standard of Care	Active Comparator	Standard of care treatments for COVID-19 as determined appropriate by the Investigator	Other: Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abivertinib	Drug	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.	Abivertinib with Standard of Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Randomization to Day 28

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events	Number of Participants with Treatment-emergent Adverse Events	Randomization through study completion to 94 days
Percentage of Subjects Alive and Free of Respiratory Failure at Day 60

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed infection with SARS-CoV-2 per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization
Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen saturation <94% on room air or subject requires supplemental oxygen
Able to swallow capsules
Willing to follow contraception guidelines
Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used

Exclusion Criteria:

Known cardio-pulmonary resuscitation within 14 days prior to randomization
Pregnant or breast feeding
Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN) and total bilirubin > 2x ULN
QTcF prolongation >480 milliseconds
Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
Treatment with a strong cytochrome P450 (CYP3A4 inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug)
Received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, BTK inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Any condition that confounds the ability to interpret data from the study
Relevant renal impairment (eGFR <60 mL/min)
Any significant medical condition, laboratory abnormality or psychiatric illness that would interfere or prevent the subject from participating in the study

Name	Affiliation	Role
Mike Royal, MD JD	Sorrento Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
MedStar Washington Hospital Center		Washington D.C.	District of Columbia	20010	United States
Teradan Clinical Trials

Arm/Group Information

ID	Title	Description
FG000	Abivertinib With Standard of Care	STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: 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: Standard of Care as determined by the Investigator
FG001	Placebo With Standard of Care	Oral placebo capsule administered orally QD up to 28 days or until hospital discharge, in addition to standard of care of care treatment for COVID-19 as determined appropriate by the Investigator Standard of Care: Standard of Care as determined by the Investigator

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Abivertinib With Standard of Care	STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: 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: Standard of Care as determined by the Investigator

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

A total of 48 subjects in the STI-5656 group and 48 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.

Posted

Count of Participants

Participants

Randomization to Day 28

ID	Title	Description
OG000	Abivertinib With Standard of Care

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Abivertinib With Standard of Care	STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Abivertinib: 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: Standard of Care as determined by the Investigator

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v23.0	Systematic Assessment

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 7, 2020	Sep 8, 2022	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jan 4, 2020	Sep 15, 2022	SAP_001.pdf

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Term
C000630672	abivertinib
D059039	Standard of Care