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Trial record 3 of 12 for:    abivertinib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528667
Recruitment Status : Completed
First Posted : August 27, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 20, 2020
First Posted Date  ICMJE August 27, 2020
Last Update Posted Date November 3, 2021
Actual Study Start Date  ICMJE January 6, 2021
Actual Primary Completion Date August 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • 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
  • 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
  • Number of days hospitalized [ Time Frame: Randomization to Day 36 ]
    Number of days hospitalized from randomization through 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
  • 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
  • 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
  • AUC of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Area under the serum concentration-time curve (AUC) of STI-5656
  • Cmax of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Maximum observed serum concentration (Cmax) of STI-5656
  • t½ of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Apparent serum terminal elimination half life (t½) of STI-5656
  • 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
  • Tmax of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Time to Cmax (Tmax) of STI-5656
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: STI-5656
    STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
    Other Names:
    • abivertinib maleate
    • avitinib
    • AC0010
    • abivertinib
  • Drug: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Experimental: STI-5656
    STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care
    Intervention: Drug: STI-5656
  • Placebo Comparator: Placebo
    Placebo capsules administered orally daily for 7 days, in addition to standard of care
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2021)
396
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2020)
400
Actual Study Completion Date  ICMJE October 7, 2021
Actual Primary Completion Date August 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04528667
Other Study ID Numbers  ICMJE BTK-COV-202BR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sorrento Therapeutics, Inc.
Study Sponsor  ICMJE Sorrento Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
PRS Account Sorrento Therapeutics, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP