NCT05009732

A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an adaptive Phase III randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of Proxalutamide (GT0918) in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted globally. The study will compare GT0918 plus standard of care (SOC) with the placebo plus SOC. Approximately 762 subjects will be randomized in a 1:1 ratio to either GT0918 plus SOC or placebo plus SOC group.

Detailed description

Coronavirus disease 2019 (COVID-19) emerged in late 2019 and spread rapidly, resulting in a global pandemic.SARS-CoV-2 encodes nonstructural and structural proteins required for its viral life cycle. Among them, the spike glycoprotein plays a pivotal role in SARS-CoV-2 infection by recognizing and attaching to ACE2 transmembrane protein on host cells. Kintor protocol has been designed to evaluate efficacy and safety of GT0918 in hospitalized subjects with COVID-19 illness. The target population of this study are hospitalized subjects with COVID-19 illness with positive SARS-CoV-2 virus test within 72 hours of randomization. The study will evaluate anti-androgen therapy may effectively prevent progression to the more severe form of COVID-19 illness and death, shorten the time to sustained recovery and decrease the mortality rate. Subject will receive either GT0918 plus standard of care or matched placebo plus standard of care. GT0918/placebo will be given 300mg orally once a day around 30 minutes after meal for 7 days and can be extended up to 14 days per investigator discretion

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	GT0918	300mg once daily orally
DRUG	Standard of care	Local standard of care per written policies or guidelines
DRUG	Matching placebo	Matching placebo

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-02-06
• Completion: 2023-07-14
• First posted: 2021-08-17
• Last updated: 2023-08-18

Locations

30 sites across 5 countries: United States, China, Philippines, South Africa, Ukraine

Regulatory

• FDA-regulated drug study