A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
NCT04869228 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380
Last updated 2023-08-18
Summary
The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease
Conditions
Interventions
- DRUG
-
GT0918 tablets or placebo
GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals
Sponsors & Collaborators
-
Suzhou Kintor Pharmaceutical Inc,
lead INDUSTRY
Principal Investigators
-
Cristhieni Rodrigues · Hospital Santa Paula
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-04
- Primary Completion
- 2022-09-02
- Completion
- 2023-08-02
Countries
- Brazil
Study Locations
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