EUCTR2020-001331-26-GB进行中（未招募）1 期
ChemoPROphyLaxIs For covId-19 infeCtious disease (the PROLIFIC trial) - PROLIFIC Trial (COVID-19)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •To be included in the trial the participant MUST:
- •1)Have given written informed consent to participate
- •2)Be aged 18 years to 70 years
- •3)Not previously have been diagnosed with COVID-19
- •4)Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care
- •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 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •The presence of any of the following will mean participants are ineligible:
- •1)Known COVID-19 positive test at baseline (if available)
- •2)Symptomatic for possible COVID-19 at baseline
- •3)Known hypersensitivity reaction to HCQ, chloroquine or 4-aminoquinolines
- •4)Known retinal disease
- •5)Known porphyria
- •6)Known chronic kidney disease (CKD; eGFR<30ml/min)
- •7)Known epilepsy
- •8)Known heart failure or conduction problems
- •9)Known significant liver disease (Gilbert’s syndrome is permitted)
- •10)Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •11)Currently taking any of the following contraindicated medications:
- •b.Chloroquine
- •c.Halofantrine
- •d.Amiodarone
- •e.Moxifloxacin
- •f.Cyclosporin
- •g.Mefloquine
- •h.Praziquantel
- •i.Ciprofloxacin
- •j.Clarithromycin
- •k.Prochlorperazine
- •l.Fluconazole
- •12)Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine
- •13)Currently breastfeeding
- •14)Unable to be followed-up during the trial
- •15)Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit
- •16)Not able to use or have access to a modern phone device/web-based technology
- •17)Any other clinical reason which may preclude entry in the opinion of the investigator
研究者
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