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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04528667
• Other study ID #: BTK-COV-202BR
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2021
• Est. completion date: October 7, 2021

Study information

• Verified date: November 2021
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: October 7, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• STI-5656
STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
• Placebo
Placebo capsules

Locations

Country	Name	City	State
Brazil	Hospital e Maternidade Christovão da Gama	Santo André	SP

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of adverse events (safety)	Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events	Randomization through study completion through Day 36
Secondary	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	Randomization through study completion through Day 36
Secondary	Number of days hospitalized	Number of days hospitalized from randomization through Day 36	Randomization to Day 36
Secondary	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	Randomization to Day 3, Day 10, and Day 36
Secondary	Change in RT-PCR test results	Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36	Randomization to Day 3, Day 10, and Day 36
Secondary	Change in C-reactive protein levels	Change in C-reactive protein (CRP) levels at Day 3 and Day 10	Randomization to Day 3 and Day 10
Secondary	AUC of STI-5656 (PK)	Area under the serum concentration-time curve (AUC) of STI-5656	Randomization through Day 8
Secondary	Cmax of STI-5656 (PK)	Maximum observed serum concentration (Cmax) of STI-5656	Randomization through Day 8
Secondary	t½ of STI-5656 (PK)	Apparent serum terminal elimination half life (t½) of STI-5656	Randomization through Day 8
Secondary	Change in cytokine levels	Change in cytokine levels (including IL-6, TNF-a, IFN?, IL1ß) at Day 3 and Day 10	Randomization to Day 3 and Day 10
Secondary	Tmax of STI-5656 (PK)	Time to Cmax (Tmax) of STI-5656	Randomization through Day 8