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

NCT04528667 | Completed Phase 2

• 1 other identifier: BTK-COV-202BR
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects discharged from hospital

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

  Randomization through Day 29

Secondary Outcomes (11)

• Incidence of adverse events (safety)

  Randomization through study completion through Day 36

• Time to hospital admission, treatment, and discharge

  Randomization through study completion through Day 36

• Number of days hospitalized

  Randomization to Day 36

• Change in clinical status as assessed using a 0-8 ordinal scale

  Randomization to Day 3, Day 10, and Day 36

• Change in RT-PCR test results

  Randomization to Day 3, Day 10, and Day 36

Study Arms (2)

STI-5656

EXPERIMENTAL

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

Drug: STI-5656

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

STI-5656 DRUG

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

Also known as: abivertinib maleate, avitinib, AC0010, abivertinib

STI-5656

Placebo DRUG

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (1)

Hospital e Maternidade Christovão da Gama

Santo André, São Paulo, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

abivertinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 27, 2020
• Study Start: January 6, 2021
• Primary Completion: August 23, 2021
• Study Completion: October 7, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Locations

BR (1)