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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 : Active, not recruiting
First Posted : June 19, 2020
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Abivertinib Other: Standard of Care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : May 5, 2021
Estimated Study Completion Date : July 2021

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. Change in CRP [ Time Frame: Randomization to Day 28 ]
    Percent change from baseline in CRP at Days 3, 5, 7, 10, 14, 28

  7. Change from baseline in oxygenation index [ Time Frame: Randomization to Day 5 ]
    Relative change from baseline in PaO2/FiO2 up to Day 5

  8. All-cause mortality at Day 60 and Day 90 [ Time Frame: Ranomization through Day 90 ]
    All-cause mortality at Day 60 and Day 90

  9. 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

  10. 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

  11. Number of days hospitalized up to Day 28 [ Time Frame: Randomization to Day 28 ]
    Number of days hospitalized up to Day 28

  12. 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

  13. 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

  14. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440007


Locations
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United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Teradan Clinical Trials
Brandon, Florida, United States, 33511
United States, Louisiana
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States, 71301
Clinical Trials of SWLA
Lake Charles, Louisiana, United States, 70601
United States, Nebraska
Quality Clinical Research
Omaha, Nebraska, United States, 68114
United States, Texas
Memorial Hermann Memorial City Hospital
Houston, Texas, United States, 77024
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD JD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04440007    
Other Study ID Numbers: STI-5656-2001
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Abivertinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors