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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
STI-5656
Placebo
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital e Maternidade Christovão da Gama

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

STI-5656

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of subjects discharged from hospital
Proportion of subjects whoa re alive and discharged from the hospital by Day 29

Secondary Outcome Measures

Incidence of adverse events (safety)
Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events
Time to hospital admission, treatment, and discharge
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
Number of days hospitalized
Number of days hospitalized from randomization through Day 36
Change in clinical status as assessed using a 0-8 ordinal scale
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
Change in RT-PCR test results
Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36
Change in C-reactive protein levels
Change in C-reactive protein (CRP) levels at Day 3 and Day 10
AUC of STI-5656 (PK)
Area under the serum concentration-time curve (AUC) of STI-5656
Cmax of STI-5656 (PK)
Maximum observed serum concentration (Cmax) of STI-5656
t½ of STI-5656 (PK)
Apparent serum terminal elimination half life (t½) of STI-5656
Change in cytokine levels
Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10
Tmax of STI-5656 (PK)
Time to Cmax (Tmax) of STI-5656

Full Information

First Posted
August 20, 2020
Last Updated
November 1, 2021
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04528667
Brief Title
Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STI-5656
Arm Type
Experimental
Arm Description
STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules administered orally daily for 7 days, in addition to standard of care
Intervention Type
Drug
Intervention Name(s)
STI-5656
Other Intervention Name(s)
abivertinib maleate, avitinib, AC0010, abivertinib
Intervention Description
STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules
Primary Outcome Measure Information:
Title
Proportion of subjects discharged from hospital
Description
Proportion of subjects whoa re alive and discharged from the hospital by Day 29
Time Frame
Randomization through Day 29
Secondary Outcome Measure Information:
Title
Incidence of adverse events (safety)
Description
Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events
Time Frame
Randomization through study completion through Day 36
Title
Time to hospital admission, treatment, and discharge
Description
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
Time Frame
Randomization through study completion through Day 36
Title
Number of days hospitalized
Description
Number of days hospitalized from randomization through Day 36
Time Frame
Randomization to Day 36
Title
Change in clinical status as assessed using a 0-8 ordinal scale
Description
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
Time Frame
Randomization to Day 3, Day 10, and Day 36
Title
Change in RT-PCR test results
Description
Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36
Time Frame
Randomization to Day 3, Day 10, and Day 36
Title
Change in C-reactive protein levels
Description
Change in C-reactive protein (CRP) levels at Day 3 and Day 10
Time Frame
Randomization to Day 3 and Day 10
Title
AUC of STI-5656 (PK)
Description
Area under the serum concentration-time curve (AUC) of STI-5656
Time Frame
Randomization through Day 8
Title
Cmax of STI-5656 (PK)
Description
Maximum observed serum concentration (Cmax) of STI-5656
Time Frame
Randomization through Day 8
Title
t½ of STI-5656 (PK)
Description
Apparent serum terminal elimination half life (t½) of STI-5656
Time Frame
Randomization through Day 8
Title
Change in cytokine levels
Description
Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10
Time Frame
Randomization to Day 3 and Day 10
Title
Tmax of STI-5656 (PK)
Description
Time to Cmax (Tmax) of STI-5656
Time Frame
Randomization through Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital e Maternidade Christovão da Gama
City
Santo André
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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