Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19
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.
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 Name: Array
Other: Standard of Care
Standard of Care as determined by the Investigator
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
MedStar Washington Hospital Center
Washington, District of Columbia, United States
Teradan Clinical Trials
Brandon, Florida, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States
Clinical Trials of SWLA
Lake Charles, Louisiana, United States
Quality Clinical Research
Omaha, Nebraska, United States
Memorial Hermann Memorial City Hospital
Houston, Texas, United States
Mike Royal, MD JD, Study Director
Sorrento Therapeutics, Inc.