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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-09

Study Completion Date

2021-08-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Abivertinib

Intervention Type 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.

Standard of Care

Intervention Type OTHER

Standard of Care as determined by the Investigator

Standard of Care

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

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard of Care as determined by the Investigator

Interventions

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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.

Intervention Type DRUG

Standard of Care

Standard of Care as determined by the Investigator

Intervention Type OTHER

Other Intervention Names

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abivertinib maleate avitinib AC0010 STI-5656

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No