Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-11 @ 6:12 PM
Study NCT ID:
NCT05009732
Status:
TERMINATED
Last Update Posted:
2023-08-18
First Post:
2021-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
Sponsor:
Suzhou Kintor Pharmaceutical Inc,
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor's decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: