NCT04869228终止3 期
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
Suzhou Kintor Pharmaceutical Inc,1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2021年8月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Percentage of subjects requiring oxygen by Day 28
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GT0918 in the treatment arm
Experimental
GT0918 tablets : oral, 1 time / day, 2 tablets / time, after meals
干预措施: GT0918 tablets or placebo (Drug)
Placebo in the placebo arm
Placebo Comparator
placebo : oral, 1 time / day, 2 tablets / time, after meals
干预措施: GT0918 tablets or placebo (Drug)
结局指标
主要结局
Percentage of subjects requiring oxygen by Day 28
时间窗: 28days
次要结局
- 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)
研究者
研究点 (1)
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