Clinical trial NCT04440007: Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Alive and Free of Respiratory Failure at Day 28
timeFrame: Randomization to Day 28
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: Randomization through study completion to 94 days
measure: Percentage of Subjects Alive and Free of Respiratory Failure at Day 60
timeFrame: Randomization to Day 60
measure: Change in C-Reactive Protein (CRP)
timeFrame: Day 7
measure: Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)
timeFrame: Day 1
measure: All-cause Mortality at Day 60 and Day 90
timeFrame: Day 60 and Day 90
measure: Number of Days Alive Outside of Hospital up to Day 28
timeFrame: Randomization up to Day 28
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Brandon
country: United States
facility: Teradan Clinical Trials
state: Florida
city: Alexandria
country: United States
facility: Alexandria Cardiology Clinic
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA
state: Louisiana
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Houston
country: United States
facility: Memorial Hermann Memorial City Hospital
state: Texas
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD JD
role: STUDY_DIRECTOR
References: