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

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ClinicalTrials.gov Identifier: NCT04440007
Recruitment Status : Completed
First Posted : June 19, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 17, 2020
First Posted Date  ICMJE June 19, 2020
Last Update Posted Date November 3, 2021
Actual Study Start Date  ICMJE October 9, 2020
Actual Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2021)
Proportion of subjects alive and free of respiratory failure at Day 28 [ Time Frame: Randomization to Day 28 ]
Proportion of subjects alive and free of respiratory failure at Day 28
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
Proportion of subjects alive and free of respiratory failure at Day 14 [ Time Frame: Randomization to Day 14 ]
Proportion of subjects alive and free of respiratory failure at Day 14
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2021)
  • Incidence of treatment-emergent adverse events (safety and tolerability of STI-5656) [ Time Frame: Randomization through study completion to 90 days ]
    Types, frequencies, and severities of adverse events and their relationships to STI-5656
  • Proportion of subjects alive and free of respiratory failure at Day 60 [ Time Frame: Randomization to Day 60 ]
    Proportion of subjects alive and free of respiratory failure at Day 60
  • Change in clinical status [ Time Frame: Randomization to Day 7, Day 14, and Day 28 ]
    Change in clinical status on a 0-8-point ordinal scale (lower score means better outcome; 0=uninfected, 8=dead)
  • Discharge from ICU [ Time Frame: Randomization to Day 14 and Day 28 ]
    Proportion of subjects alive and discharged from ICU at Days 14 and 28
  • Time to respiratory failure or death [ Time Frame: Randomization to Day 28 ]
    Time from randomization to first occurrence of respiratory failure or death on study due to any cause up to Day 28
  • Change in CRP [ Time Frame: Randomization to Day 28 ]
    Percent change from baseline in CRP at Days 3, 5, 7, 10, 14, 28
  • Change from baseline in oxygenation index [ Time Frame: Randomization to Day 5 ]
    Relative change from baseline in PaO2/FiO2 up to Day 5
  • All-cause mortality at Day 60 and Day 90 [ Time Frame: Ranomization through Day 90 ]
    All-cause mortality at Day 60 and Day 90
  • Number of days alive and free of respiratory failure at Day 28 [ Time Frame: Randomization to Day 28 ]
    Number of days alive and free of respiratory failure at Day 28
  • Number of days with respiratory failure up to Day 28 [ Time Frame: Randomization to Day 28 ]
    Number of days with respiratory failure up to Day 28
  • Number of days hospitalized up to Day 28 [ Time Frame: Randomization to Day 28 ]
    Number of days hospitalized up to Day 28
  • Number of days in ICU (length of stay) up to Day 90 [ Time Frame: Randomization to Day 28 ]
    Number of days in ICU (length of stay) up to Day 90
  • Number of days alive outside of hospital up to Day 28 [ Time Frame: Randomization to Day 28 ]
    Number of days alive outside of hospital up to Day 28
  • Number of days alive outside of hospital up to Day 90 [ Time Frame: Randomization to Day 90 ]
    Number of days alive outside of hospital up to Day 90
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Safety and tolerability of STI-5656 [ Time Frame: Randomization through study completion to 90 days ]
    Types, frequencies, and severities of adverse events and their relationships to STI-5656
  • Proportion of subjects alive and free of respiratory failure at Day 28 [ Time Frame: Randomization to Day 28 ]
    Proportion of subjects alive and free of respiratory failure at Day 28
  • Change in clinical status [ Time Frame: Randomization to Day 7, Day 14, and Day 28 ]
    Change in clinical status on a 0-8-point ordinal scale (lower score means better outcome; 0=uninfected, 8=dead)
  • Discharge from ICU [ Time Frame: Randomization to Day 14 and Day 28 ]
    Proportion of subjects alive and discharged from ICU at Days 14 and 28
  • Time to respiratory failure or death [ Time Frame: Randomization to Day 28 ]
    Time from randomization to first occurrence of respiratory failure or death on study due to any cause up to Day 28
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19
Official Title  ICMJE 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
Brief Summary Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid-19
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Abivertinib
    • Other: Standard of Care
  • Active Comparator: Standard of Care
    Standard of care treatments for COVID-19 as determined appropriate by the Investigator
    Intervention: Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2021)
92
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2020)
80
Actual Study Completion Date  ICMJE August 23, 2021
Actual Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04440007
Other Study ID Numbers  ICMJE STI-5656-2001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sorrento Therapeutics, Inc.
Study Sponsor  ICMJE Sorrento Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike Royal, MD JD Sorrento Therapeutics, Inc.
PRS Account Sorrento Therapeutics, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP