A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19
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.
Drug: STI-5656
STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
Other Name: Array
Drug: Placebo
Placebo capsules
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
Hospital e Maternidade Christovão da Gama
Santo André, SP, Brazil
Mike Royal, MD, Study Director
Sorrento Therapeutics, Inc.