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Completed

NCT Number: NCT04528667

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital e Maternidade Christovão da Gama

Santo André, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STI-5656

Drug

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

Other names: abivertinib maleate, avitinib, AC0010, abivertinib

Placebo

Drug

Placebo capsules

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sorrento Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2020
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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