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

Primary Purpose

Covid-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abivertinib
Standard of Care
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MedStar Washington Hospital Center
  • Teradan Clinical Trials
  • Alexandria Cardiology Clinic
  • Clinical Trials of SWLA
  • Quality Clinical Research
  • Memorial Hermann Memorial City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abivertinib with Standard of Care

Standard of Care

Arm Description

STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care

Standard of care treatments for COVID-19 as determined appropriate by the Investigator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events
Number of Participants with Treatment-emergent Adverse Events
Percentage of Subjects Alive and Free of Respiratory Failure at Day 60
Percentage of subjects alive and free of respiratory failure at Day 60
Change in C-Reactive Protein (CRP)
Mean change in CRP on Day 7
Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)
PaO2/FiO2 at Day 1
All-cause Mortality at Day 60 and Day 90
All-cause mortality at 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

Full Information

First Posted
June 17, 2020
Last Updated
December 21, 2022
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04440007
Brief Title
Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abivertinib with Standard of Care
Arm Type
Experimental
Arm Description
STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care treatments for COVID-19 as determined appropriate by the Investigator
Intervention Type
Drug
Intervention Name(s)
Abivertinib
Other Intervention Name(s)
abivertinib maleate, avitinib, AC0010, STI-5656
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care as determined by the Investigator
Primary Outcome Measure Information:
Title
Percentage of Subjects Alive and Free of Respiratory Failure at Day 28
Description
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
Time Frame
Randomization to Day 28
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events
Description
Number of Participants with Treatment-emergent Adverse Events
Time Frame
Randomization through study completion to 94 days
Title
Percentage of Subjects Alive and Free of Respiratory Failure at Day 60
Description
Percentage of subjects alive and free of respiratory failure at Day 60
Time Frame
Randomization to Day 60
Title
Change in C-Reactive Protein (CRP)
Description
Mean change in CRP on Day 7
Time Frame
Day 7
Title
Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)
Description
PaO2/FiO2 at Day 1
Time Frame
Day 1
Title
All-cause Mortality at Day 60 and Day 90
Description
All-cause mortality at Day 60 and Day 90
Time Frame
Day 60 and Day 90
Title
Number of Days Alive Outside of Hospital up to Day 28
Description
Number of days alive outside of hospital up to Day 28
Time Frame
Randomization up to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD JD
Organizational Affiliation
Sorrento Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Teradan Clinical Trials
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Alexandria Cardiology Clinic
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Clinical Trials of SWLA
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Memorial Hermann Memorial City Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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