EUCTR2020-002027-10-SE进行中（未招募）1 期
A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19) - COVIDENZA
orrlands universitetssjukhus0 个研究点目标入组 600 人开始时间: 2020年4月24日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Positive COVID-19 test
- •- Mild to severe symptoms of COVID-19
- •- Recent hospitalization due to COVID-19 (0-3 days)
- •- WHO performance status 0-3
- •- Age above or equal to 50 years
- •- Can understand all the requirements of the study, provide informed consent, and provide
- •authorization of use and disclosure of personal health information.
- •- Estimated expected survival of 1 year (excluding symptoms due to COVID-19)
- •- Women of Childbearing Capacity (WOCBC) must:
- •a) Comply to use of highly effective contraception methods from start of the trial until three months after the last dose of study medication. Acceptable methods according to CTFG guidelines are combined hormonal contraception (oral, dermal, intravaginal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), an intrauterine device, an intrauterine hormone-releasing system or by refraining from heterosexual intercourse during the entire period of risk. Women of Childbearing Capacity (WOCBC) must:
- •b) Have a negative pregnancy test
- •- Male patients included in the study that have fertile female partners must use adequate contraception within their relationship from start of the trial until three months after the last dose of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •oSevere allergy to enzalutamide
- •oPregnant or Breast-feeding women
- •oNeed of immediate mechanical ventilation
- •oCurrent hormonal therapy for prostate and breast cancer (finasteride or dutasteride is allowed)
- •oTreatment for HIV
- •oTreatment with warfarin or Clopidogrel
- •oTreatment with immunosuppressive agents. Allowed exceptions are: equivalent medication to prednisolone 10 mg/day or low dose methotrexate 15 mg/week. Any treatment initiated as standard of care for COVID-19 is allowed.
- •oSevere immunosuppressive disease
- •oOther serious illness or medical condition
- •oCurrent symptomatic unstable cardiovascular disease
- •oStroke in medical history
- •oEpileptic seizure in medical history
研究者
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