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Completed

NCT Number: NCT04440007

Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) 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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abivertinib

Drug

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

Standard of care

Other

Standard of Care as determined by the Investigator

Primary outcomes

  1. Percentage of Subjects Alive and Free of Respiratory Failure at Day 28

    Time frame: Randomization to 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 outcomes

  1. Number of Participants With Treatment-emergent Adverse Events

    Time frame: Randomization through study completion to 94 days

    Number of Participants with Treatment-emergent Adverse Events

  2. Percentage of Subjects Alive and Free of Respiratory Failure at Day 60

    Time frame: Randomization to Day 60

    Percentage of subjects alive and free of respiratory failure at Day 60

  3. Change in C-Reactive Protein (CRP)

    Time frame: Day 7

    Mean change in CRP on Day 7

  4. Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)

    Time frame: Day 1

    PaO2/FiO2 at Day 1

  5. All-cause Mortality at Day 60 and Day 90

    Time frame: Day 60 and Day 90

    All-cause mortality at Day 60 and Day 90

  6. Number of Days Alive Outside of Hospital up to Day 28

    Time frame: Randomization up to Day 28

    Number of days alive outside of hospital up to Day 28

Sponsors and collaborators

Lead sponsor

Sorrento Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: SOC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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