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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • abivertinib maleate
    • avitinib
    • AC0010
    • 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
  • 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:
    • abivertinib maleate
    • avitinib
    • AC0010
    • STI-5656
  • Other: Standard of Care
    Standard of Care as determined by the Investigator

Recruiting Locations

More Details

NCT ID
NCT04440007
Status
Completed
Sponsor
Sorrento Therapeutics, Inc.

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.