CTRI/2021/12/038850尚未招募3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 668
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy in terms of clinical status following treatment with GT0918 compared to placebo
研究概览
简要总结
This is a Phase 3 Study to Evaluate the Efficacy and Safety of GT0918 inOutpatiThis is a Phase 3 Study to Evaluate the Efficacy and Safety of GT0918 inOutpatients with Mild to Moderate COVID-19 Illness ents with Mild to Moderate COVID-19 Illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be considered eligible for the study based on the following criteria:
- •The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Understand and agree to comply with planned study procedures.
- •Male and non-pregnant female subjects with age greater than or equal to 18 years of age at the time of randomization
- •Are currently not hospitalized.
- •Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) less than or equal to 3 days prior to start of the first dose.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception, as shown below, throughout the study and for 3 months after stopping GT0918 treatment.
- •Highly effective contraception methods include: Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient.
- •Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or Use of one of the following combinations (a+b or a+c or b+c): a.Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1%), for example hormone vaginal ring or transdermal hormone contraception.
- •b.Placement of an intrauterine device or intrauterine system; c.Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or vaginal suppository; Female sterilization (have had prior surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
- •In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment; Male sterilization (at least 6 months prior to screening).
- •For female subjects on the study, the vasectomized male partner should be the sole partner for that subject; In case of use of oral contraception women should have been stable for a minimum of 3 months before taking study treatment.
- •Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago.
- •In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, is she considered not of childbearing potential;
- •Regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1 percent failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose.
- •Agree to the collection of nasopharyngeal swabs and venous blood.
排除标准
- •Subjects will be excluded from the study based on the following criteria: Have SpO2 less than or equal to 93% on room air at sea level or PaO2 or FiO2 less than300, respiratory rate greater than or equal to30 per minute, heart rate greater than or equal to125 per minute (FDA resource page, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (fda.gov)).
- •Estimated glomerular filtration rate (eGFR) less than30 ml per min Serum total bilirubin greater than 1.5 x ULN (upper limit of normal) and AST and ALT greater than3 x ULN Subjects with significant cardiovascular disease as following: i.
- •heart failure NYHA class greater than or equal to3 ii.
- •left ventricular ejection fraction less than 50 percent iii.
- •those with a history of cardiac arrhythmias, including long QT syndrome.
- •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 interventions.
- •Have hemodynamic instability requiring use of vasopressors within 24 hours of randomization.
- •Suspected or proven serious, active bacterial, fungal, viral, or other infection (except COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention (i.e. known history of human immunodeficiency virus [HIV]).
- •Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 30 days.
- •Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
- •Subjects with myopathy.
- •Prior, current, or planned future use of any of the following treatments: 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.
- •Have participated, within the last 30 days, in a clinical study involving an investigational intervention.
- •If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- •Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Subject taking an anti-androgen of any type including androgen depravation therapy, 5-alpha reductase inhibitors, etc.
- •within 3 months before dosing.
- •Are investigator site personnel directly affiliated with this study.
结局指标
主要结局
To evaluate the efficacy in terms of clinical status following treatment with GT0918 compared to placebo
时间窗: Study Duration: 42 Days
次要结局
- 1.To evaluate the clinical efficacy of GT0918 compared to placebo using the NIAID 8- point scoring scale(2.To evaluate the clinical efficacy of GT0918 compared to placebo based on clinical status)
研究者
研究点 (2)
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