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

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

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

Study Overview

• Status: Completed
• Conditions: Covid-19
• Intervention / Treatment: Drug: Abivertinib; Other: Standard of Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Brandon, Florida, United States, 33511
      • Teradan Clinical Trials
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Alexandria Cardiology Clinic
    • Lake Charles, Louisiana, United States, 70601
      • Clinical Trials of SWLA
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • Texas
    • Houston, Texas, United States, 77024
      • Memorial Hermann Memorial City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 Names: AC0010; abivertinib maleate; avitinib; STI-5656; Other: Standard of Care; Standard of Care as determined by the Investigator
Active Comparator: Standard of Care; Standard of care treatments for COVID-19 as determined appropriate by the Investigator	Other: Standard of Care; Standard of Care as determined by the Investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Percentage of subjects alive and free of respiratory failure at Day 60	Randomization to Day 60
Change in C-Reactive Protein (CRP)	Mean change in CRP on Day 7	Day 7
Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)	PaO2/FiO2 at Day 1	Day 1
All-cause Mortality at Day 60 and Day 90	All-cause mortality at Day 60 and Day 90	Day 60 and Day 90
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

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abivertinib
• Other Study ID Numbers: STI-5656-2001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No