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

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

Purpose of Study

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.

Eligibility

Age:
18 +
Sex:
All

Key Inclusion / Exclusion Criteria

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

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

Conditions:

COVID-19

Status:

Completed

Phase:

Phase 2

Study ID

NCT04528667

Read Detailed Summary

Start Date / End Date:

06/01/2021 -

Enrollment:

396

Full Details:

https://clinicaltrials.gov/ct2/show/NCT04528667

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1 Study Locations

Brazil

Hospital e Maternidade Christovão da Gama
Santo André, SP,
Brazil


Study Locations Map: