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

Sorrento Therapeutics

Status and phase: Completed; Phase 2

Conditions: Covid19

Treatments: Drug: Placebo; Drug: STI-5656

Study type: Interventional

Funder types: Industry

Identifiers

NCT04528667

BTK-COV-202BR

Details and patient eligibility

About

A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19

Full description

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.

Enrollment: 396 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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396 participants in 2 patient groups, including a placebo group

STI-5656

Experimental group

Description:

STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care

Treatment:

Drug: STI-5656

Placebo

Placebo Comparator group

Description:

Placebo capsules administered orally daily for 7 days, in addition to standard of care

Treatment:

Drug: Placebo