NCT04528667

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	STI-5656	STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
DRUG	Placebo	Placebo capsules

Timeline

• Start date: 2021-01-06
• Primary completion: 2021-08-23
• Completion: 2021-10-07
• First posted: 2020-08-27
• Last updated: 2021-11-03

Locations

1 site across 1 country: Brazil