EUCTR2020-001449-38-GB进行中（未招募）1 期
A Randomised Controlled Trial of Early Intervention in Patients HospItalised with COVID-19: Favipiravir verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe - PIONEER
Chelsea and Westminster Hospital NHS Foundation Trust0 个研究点目标入组 450 人开始时间: 2020年4月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- •he participant may enter the study if the following apply:
- •1.Adult participants: Signed informed consent
- •2.New admission to hospital for period expected to last = 1 night
- •3.Suspected or confirmed COVID-19 infection
- •Patients are suspected of COVID-19 infection if they have one of the following:
- •·Influenza like illness (fever =37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing).
- •·Acute respiratory distress syndrome
- •·Radiological evidence of pneumonia
- •4.For women to be eligible to enter and participate in the study they should be: of non-child-bearing
- •-potential defined as either post-menopausal (12 months of spontaneous amenorrhea and = 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- •-or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of < 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method.
- •5.Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •1.Pregnant or breast feeding, due to potential teratogenicity
- •2.Hepatic impairment – (AST or ALT > 3.5 x upper limit of normal)
- •3.Renal impairment – (eGFR <10ml/ minute)
- •4.Known history of retinopathy
- •5.Known history of G6PD deficiency
- •6.Known history of Myasthenia gravis
- •7.QT-prolongation (>430ms in males or >450ms in females, calculated as per investigators discretion)
- •8.Presently enrolled in an interventional drug study or on hydroxychloroquine or azithromycin for other therapeutic reasons
- •9.Unable to take medication via the oral or nasogastric route
- •10.Immunocompromised patients (see Appendix C)
- •11.Known sensitivity to Azithromycin (or other macrolide drugs), Hydroxychloroquine, zinc or Favipiravir
- •NB See Section 9.1 for dose reduction guidance for patients with eGFR <50ml/ minute
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