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

NCT04440007 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STI-5656-2001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Alive and Free of Respiratory Failure at Day 28

  Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities: * Noninvasive positive pressure ventilation or continuous positive airway pressure * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥ 0.5) * Extracorporeal membrane oxygenation

  Randomization to Day 28

Secondary Outcomes (6)

• Number of Participants With Treatment-emergent Adverse Events

  Randomization through study completion to 94 days

• Percentage of Subjects Alive and Free of Respiratory Failure at Day 60

  Randomization to Day 60

• Change in C-Reactive Protein (CRP)

  Day 7

• Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)

  Day 1

• All-cause Mortality at Day 60 and Day 90

  Day 60 and Day 90

Study Arms (2)

Abivertinib with Standard of Care

EXPERIMENTAL

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; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Abivertinib DRUG

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.

Also known as: abivertinib maleate, avitinib, AC0010, STI-5656

Abivertinib with Standard of Care

Standard of Care OTHER

Standard of Care as determined by the Investigator

Abivertinib with Standard of Care; Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (6)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Teradan Clinical Trials

Brandon, Florida, 33511, United States

Location

Alexandria Cardiology Clinic

Alexandria, Louisiana, 71301, United States

Location

Clinical Trials of SWLA

Lake Charles, Louisiana, 70601, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Memorial Hermann Memorial City Hospital

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

abivertinib; Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Mike Royal, MD
• Organization: Sorrento Therapeutics, Inc.

mroyal@sorrentotherapeutics.com

858-203-4100

Study Officials

• Mike Royal, MD JD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: October 9, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 23, 2021
• Last Updated: January 18, 2023
• Results First Posted: January 18, 2023

Record last verified: 2022-12

Locations

US (6)