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

November 1, 2021 updated by: Sorrento Therapeutics, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Santo André, SP, Brazil
        • Hospital e Maternidade Christóvão da Gama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: STI-5656
STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care
Drug: STI-5656
STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
Other Names:
  • AC0010
  • abivertinib maleate
  • avitinib
  • abivertinib
Placebo Comparator: Placebo
Placebo capsules administered orally daily for 7 days, in addition to standard of care
Drug: Placebo
Placebo capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects discharged from hospital
Time Frame: Randomization through Day 29
Proportion of subjects whoa re alive and discharged from the hospital by Day 29
Randomization through Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (safety)
Time Frame: Randomization through study completion through Day 36
Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events
Randomization through study completion through Day 36
Time to hospital admission, treatment, and discharge
Time Frame: Randomization through study completion through Day 36
Time from onset of COVID-19 symptoms to hospital admission, time from hospitalization to start of treatment (D1), and time from D1 to hospital discharge
Randomization through study completion through Day 36
Number of days hospitalized
Time Frame: Randomization to Day 36
Number of days hospitalized from randomization through Day 36
Randomization to Day 36
Change in clinical status as assessed using a 0-8 ordinal scale
Time Frame: Randomization to Day 3, Day 10, and Day 36
Change in clinical status as assessed using a 0-8 ordinal scale, where a lower score equals better outcome, at Days 3, 10, and 36
Randomization to Day 3, Day 10, and Day 36
Change in RT-PCR test results
Time Frame: Randomization to Day 3, Day 10, and Day 36
Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36
Randomization to Day 3, Day 10, and Day 36
Change in C-reactive protein levels
Time Frame: Randomization to Day 3 and Day 10
Change in C-reactive protein (CRP) levels at Day 3 and Day 10
Randomization to Day 3 and Day 10
AUC of STI-5656 (PK)
Time Frame: Randomization through Day 8
Area under the serum concentration-time curve (AUC) of STI-5656
Randomization through Day 8
Cmax of STI-5656 (PK)
Time Frame: Randomization through Day 8
Maximum observed serum concentration (Cmax) of STI-5656
Randomization through Day 8
t½ of STI-5656 (PK)
Time Frame: Randomization through Day 8
Apparent serum terminal elimination half life (t½) of STI-5656
Randomization through Day 8
Change in cytokine levels
Time Frame: Randomization to Day 3 and Day 10
Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10
Randomization to Day 3 and Day 10
Tmax of STI-5656 (PK)
Time Frame: Randomization through Day 8
Time to Cmax (Tmax) of STI-5656
Randomization through Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sorrento Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTK-COV-202BR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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