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

Study Overview
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Brief Summary
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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

Detailed Description
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The subjects in the experimental group will receive GT0918 (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment. The subjects in the control group will receive placebo (200mg oral once-daily (QD) for 14 consecutive days) in addition to supportive treatment.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: GT0918 tablets or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males age ≥18 years of age at the time of randomization Are currently not hospitalized for acute respiratory symptoms (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China) The subject's first positive SARS-CoV-2 viral infection test result (using an approved molecular test, or other approved commercial or public health assay on any approved specimen) must be ≤3 days prior to randomization Subjects with adequate liver and renal function Agree to the collection of nasopharyngeal swabs and venous blood The participant or legally authorized representative signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19 or requires treatment with supplemental oxygen Have known allergies to any of the components used in the formulation of the study drug or placebo Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo Have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days Have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose Prior, current, or planned future use of any of the following treatments at screening: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening Are investigator site personnel directly affiliated with this study Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days prior to randomization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GT0918 in the treatment arm<br>GT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals | Drug: GT0918 tablets or placebo<br>* GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals<br>|
| Placebo Comparator: Placebo in the placebo arm<br>placebo : oral, 1 time / day, 2 tablets / time, after meals | Drug: GT0918 tablets or placebo<br>* GT0918 tablets or placebo: oral, 1 time / day, 2 tablets / time, after meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects requiring oxygen by Day 28 |  | 28days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who experience the events(such as hospitalization,Death etc.) by Day 28. (not applicable for subjects whose countries require mild to moderate COVID-19 patients to be hospitalised, such as COVID-19 patients in mainland China) |  | 28days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19