NCT04870606

Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 733 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of Proxalutamide (GT0918) in adult outpatients diagnosed with mild to moderate COVID-19. The study will be 2-arm comparison against matched placebo. The study will be conducted in around 100 sites in the USA and other countries. This study utilizes an adaptive design that maximizes our efficiency in identifying a safe and efficacious therapeutic agent for COVID-19 during the current outbreak. There will be an interim analysis after 334 subjects complete Day 28 after the first dose to allow early stopping for futility, efficacy, or safety. The study population will be subjects with mild to moderate COVID-19 illness chosen to evaluate if early intervention with anti-androgen therapy prior to respiratory compromise can effectively prevent progression to the severe form of COVID-19 illness. Randomization is essential for establishing efficacy of these new therapeutic agents. The blood samples for PK analysis need to be collected for at least 200 subjects, whom will also be randomized into the interventional treatment or placebo group with 1:1 ratio.

Conditions

• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	Proxalutamide (GT0918)	Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory
DRUG	Placebo	Placebo+Standard of care determined by PI and local regulatory

Timeline

• Start date: 2021-03-05
• Primary completion: 2022-01-24
• Completion: 2022-04-06
• First posted: 2021-05-03
• Last updated: 2024-01-02
• Results posted: 2024-01-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study