Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19

Covid-19 Clinical Trial

— SOC  

Official title:

A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440007
• Other study ID #: STI-5656-2001
• Status: Completed
• Phase: Phase 2
• Start date: October 9, 2020
• Est. completion date: August 23, 2021

Study information

• Verified date: December 2022
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 23, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19

Intervention

Drug:
• 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.

Other:
• Standard of Care
Standard of Care as determined by the Investigator

Locations

Country	Name	City	State
United States	Alexandria Cardiology Clinic	Alexandria	Louisiana
United States	Teradan Clinical Trials	Brandon	Florida
United States	Memorial Hermann Memorial City Hospital	Houston	Texas
United States	Clinical Trials of SWLA	Lake Charles	Louisiana
United States	Quality Clinical Research	Omaha	Nebraska
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Randomization to Day 28
Secondary	Number of Participants With Treatment-emergent Adverse Events	Number of Participants with Treatment-emergent Adverse Events	Randomization through study completion to 94 days
Secondary	Percentage of Subjects Alive and Free of Respiratory Failure at Day 60	Percentage of subjects alive and free of respiratory failure at Day 60	Randomization to Day 60
Secondary	Change in C-Reactive Protein (CRP)	Mean change in CRP on Day 7	Day 7
Secondary	Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)	PaO2/FiO2 at Day 1	Day 1
Secondary	All-cause Mortality at Day 60 and Day 90	All-cause mortality at Day 60 and Day 90	Day 60 and Day 90
Secondary	Number of Days Alive Outside of Hospital up to Day 28	Number of days alive outside of hospital up to Day 28	Randomization up to Day 28