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

NCT ID: NCT04528667

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2021-10-07

Brief Summary

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A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19

Detailed Description

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This is a phase 2, randomized, double-blind, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19 in Brazil. Subjects are randomized 3:1 STI-5656 to placebo. Subjects receive either 100 mg of STI-5656 or placebo daily for 7 days. Standard of care will be maintained for all subjects throughout the study.

Conditions

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Covid19

Keywords

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covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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STI-5656

STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care

Group Type EXPERIMENTAL

STI-5656

Intervention Type DRUG

STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.

Placebo

Placebo capsules administered orally daily for 7 days, in addition to standard of care

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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STI-5656

STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Other Intervention Names

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abivertinib maleate avitinib AC0010 abivertinib

Eligibility Criteria

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Inclusion Criteria

* Confirmed positive for COVID-19 by RT-PCR assay or equivalent
* Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board (IRB) or independent ethics committee (IEC) 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 27, 2020 (Updated on July 2, 2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used
* Able to swallow capsules
* Willing to follow contraception guidelines

Exclusion Criteria

* Pregnant or breast feeding
* Suspected uncontrolled active bacterial, fungal, viral, or other infection other than COVID-19
* Treatment with a strong cytochrome p450 3A4 inhibitor or inducer within 7 days prior to Day 1
* Received anti-rejection or immunomodulatory drugs within 14 days prior to Day 1
* Concurrent participation in another clinical trial involving therapeutic interventions (observation studies are acceptable)
* Any condition that confounds the ability to interpret data from the study
* Any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere with or prevent the subject from participating in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorrento Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mike Royal, MD

Role: STUDY_DIRECTOR

Sorrento Therapeutics, Inc.

Locations

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Hospital e Maternidade Christovão da Gama

Santo André, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BTK-COV-202BR

Identifier Type: -

Identifier Source: org_study_id