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Trial record 30 of 875 for:    Not yet recruiting, Available Studies | Covid19 | Adult

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528667
Recruitment Status : Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Covid19 Drug: STI-5656 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
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:
  • abivertinib maleate
  • avitinib
  • AC0010
  • abivertinib

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Number of days hospitalized [ Time Frame: Randomization to Day 36 ]
    Number of days hospitalized from randomization through Day 36

  4. 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

  5. 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

  6. 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

  7. AUC of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Area under the serum concentration-time curve (AUC) of STI-5656

  8. Cmax of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Maximum observed serum concentration (Cmax) of STI-5656

  9. t½ of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Apparent serum terminal elimination half life (t½) of STI-5656

  10. 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

  11. Tmax of STI-5656 (PK) [ Time Frame: Randomization through Day 8 ]
    Time to Cmax (Tmax) of STI-5656



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528667


Contacts
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Contact: Mike Royal, MD 858-203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Chair: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04528667    
Other Study ID Numbers: BTK-COV-202BR
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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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
Keywords provided by Sorrento Therapeutics, Inc.:
covid-19
Additional relevant MeSH terms:
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Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action