SOC: Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19

Sponsor

Sorrento Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04440007

Collaborator

(none)

Enrollment

Locations

Arms

10.4

Actual Duration (Months)

15.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19

Condition or Disease	Intervention/Treatment	Phase
Covid-19	Drug: Abivertinib Other: Standard of Care	Phase 2

Detailed Description

This is a Phase 2, open-label, randomized 2-arm multicenter study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) administered orally plus Standard of Care (SOC) versus SOC in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 infection and COVID-19 pneumonia (documented radiographically). Only hospitalized patients are eligible for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19

Actual Study Start Date :

Oct 9, 2020

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Aug 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abivertinib with Standard of Care STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care	Drug: Abivertinib Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. Other Names: abivertinib maleate avitinib AC0010 STI-5656 Other: Standard of Care Standard of Care as determined by the Investigator
Active Comparator: Standard of Care Standard of care treatments for COVID-19 as determined appropriate by the Investigator	Other: Standard of Care Standard of Care as determined by the Investigator

Arm

Intervention/Treatment

Experimental: Abivertinib with Standard of Care

STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care

Drug: Abivertinib

Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.

Other Names:

abivertinib maleate

avitinib

AC0010

STI-5656

Other: Standard of Care

Standard of Care as determined by the Investigator

Active Comparator: Standard of Care

Standard of care treatments for COVID-19 as determined appropriate by the Investigator

Other: Standard of Care

Standard of Care as determined by the Investigator

Outcome Measures

Primary Outcome Measures

Proportion of subjects alive and free of respiratory failure at Day 28 [Randomization to Day 28]
Proportion of subjects alive and free of respiratory failure at Day 28

Secondary Outcome Measures

Incidence of treatment-emergent adverse events (safety and tolerability of STI-5656) [Randomization through study completion to 90 days]
Types, frequencies, and severities of adverse events and their relationships to STI-5656
Proportion of subjects alive and free of respiratory failure at Day 60 [Randomization to Day 60]
Proportion of subjects alive and free of respiratory failure at Day 60
Change in clinical status [Randomization to Day 7, Day 14, and Day 28]
Change in clinical status on a 0-8-point ordinal scale (lower score means better outcome; 0=uninfected, 8=dead)
Discharge from ICU [Randomization to Day 14 and Day 28]
Proportion of subjects alive and discharged from ICU at Days 14 and 28
Time to respiratory failure or death [Randomization to Day 28]
Time from randomization to first occurrence of respiratory failure or death on study due to any cause up to Day 28
Change in CRP [Randomization to Day 28]
Percent change from baseline in CRP at Days 3, 5, 7, 10, 14, 28
Change from baseline in oxygenation index [Randomization to Day 5]
Relative change from baseline in PaO2/FiO2 up to Day 5
All-cause mortality at Day 60 and Day 90 [Ranomization through Day 90]
All-cause mortality at Day 60 and Day 90
Number of days alive and free of respiratory failure at Day 28 [Randomization to Day 28]
Number of days alive and free of respiratory failure at Day 28
Number of days with respiratory failure up to Day 28 [Randomization to Day 28]
Number of days with respiratory failure up to Day 28
Number of days hospitalized up to Day 28 [Randomization to Day 28]
Number of days hospitalized up to Day 28
Number of days in ICU (length of stay) up to Day 90 [Randomization to Day 28]
Number of days in ICU (length of stay) up to Day 90
Number of days alive outside of hospital up to Day 28 [Randomization to Day 28]
Number of days alive outside of hospital up to Day 28
Number of days alive outside of hospital up to Day 90 [Randomization to Day 90]
Number of days alive outside of hospital up to Day 90

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed infection with SARS-CoV-2 per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization
Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen saturation <94% on room air or subject requires supplemental oxygen
Able to swallow capsules
Willing to follow contraception guidelines
Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board 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 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used

Exclusion Criteria:

Known cardio-pulmonary resuscitation within 14 days prior to randomization
Pregnant or breast feeding
Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN) and total bilirubin > 2x ULN
QTcF prolongation >480 milliseconds
Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
Treatment with a strong cytochrome P450 (CYP3A4 inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug)
Received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, BTK inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Any condition that confounds the ability to interpret data from the study
Relevant renal impairment (eGFR <60 mL/min)
Any significant medical condition, laboratory abnormality or psychiatric illness that would interfere or prevent the subject from participating in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
2	Teradan Clinical Trials	Brandon	Florida	United States	33511
3	Alexandria Cardiology Clinic	Alexandria	Louisiana	United States	71301
4	Clinical Trials of SWLA	Lake Charles	Louisiana	United States	70601
5	Quality Clinical Research	Omaha	Nebraska	United States	68114
6	Memorial Hermann Memorial City Hospital	Houston	Texas	United States	77024

Sponsors and Collaborators

Sorrento Therapeutics, Inc.

Investigators

Study Director: Mike Royal, MD JD, Sorrento Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sorrento Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT04440007

Other Study ID Numbers:

STI-5656-2001

First Posted:

Jun 19, 2020

Last Update Posted:

Nov 3, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Abivertinib

Study Results

No Results Posted as of Nov 3, 2021