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NCT05009732 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects
A Phase 3 study, sponsored by Suzhou Kintor Pharmaceutical Inc,.
- Terminated
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
NCT05009732: Clinical Trial Phase 3 study, sponsored by Suzhou Kintor Pharmaceutical Inc,.
NCT05009732 is a Phase 3 study that was terminated before completion, run by Suzhou Kintor Pharmaceutical Inc,. The registered enrollment target is 139 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05009732, a Phase 3 study, was terminated before completion, sponsored by Suzhou Kintor Pharmaceutical Inc,.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical deterioration is defined as the need for intensive care unit level care (ICU) or invasive mechanical ventilation/ECMO or all-cause mortality by Day 30.
Interventions
- DRUG Matching placebo
- DRUG Standard of care
- DRUG GT0918
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2023-07-14 |
| Phase | Phase 3 |
Why NCT05009732 stopped before completion
NCT05009732 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Matching placebo is the first listed.
NCT05009732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05009732 about?
NCT05009732 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects". 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 stan...
What is the current status of trial NCT05009732?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2021-09-30. Estimated completion is 2023-07-14.
What interventions are being tested in trial NCT05009732?
The interventions under investigation include: Matching placebo (DRUG), Standard of care (DRUG), GT0918 (DRUG).
Who is sponsoring clinical trial NCT05009732?
This trial is sponsored by Suzhou Kintor Pharmaceutical Inc,, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05009732's enrollment target sits among peer trials
139 1577th of 2000 higher than 424 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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