ACTRN12620000501943招募中2 期
Effectiveness of Prophylactic Hydroxychloroquine on incidence of COVID-19 infection in Front-line Health and Allied Health Care Workers: The COVID-SHIELD Trial
Walter and Eliza Hall Institute of Medical Research0 个研究点目标入组 650 人开始时间: 2020年4月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Study participant is willing to provide informed consent
- •2. Be aged 18-70 years at the time of consent and in good overall health
- •3. Health care worker at high risk of COVID-19 exposure including doctors, nurses and other allied health care workers (such as physiotherapist, radiographer, speech/occupational therapists, personal services assistants, dentist/dental nurse/dental hygienists, aged care workers, optometrist, in general practice or other health care services or paramedic (ambulance) in the following settings:
- •Emergency department
- •COVID-19 management teams: Outpatient Clinic
- •Inpatient Ward
- •Intensive care unit/ High Dependency Unit (HDU) /Operating Theatre/ Recovery
- •Groups exposed to aerosol generating procedures: eg. anaesthetics/intubation teams
- •Dental Services
- •Aged Care Homes
- •Optometry Services
- •Otolaryngology Services (ENT)
- •Occupational & Speech Therapy
- •Physiotherapy
- •Paramedicine/Ambulatory
- •General Practice
- •Other Health Care Services Worker
- •4. Anticipated to be performing clinical duties as a front-line health care worker during the trial period
- •5. Willing to adhere to study procedures including daily use of mobile electronic portal to report outcomes and adverse events
- •6. Willing to take drug/placebo as directed and to not take additional hydroxychloroquine or chloroquine during the trial period
- •7. Willing to provide COVID-19 test results and permission to use the COVID-19 registry at the end of the study to confirm COVID-19 status
- •8. Willing to report hospitalisations to the study nurse and to have review of medical records and receive follow-up phone calls to determine outcomes of hospitalisations
排除标准
- •1.Prior COVID-19
- •2.Presence of any respiratory illness inclusive of fever, cough, dyspnoea, sore throat, rhinorrhoea, nasal stuffiness, headache, myalgia and fatigue
- •3.Any cardiac arrhythmias, retinal eye disease, liver or kidney disease
- •4.Any contra-indication to hydroxychloroquine or chloroquine including allergy or hypersensitivity
- •5.Any concurrent medication which can prolong QT interval
- •6.Currently taking or planning to self-treat with hydroxychloroquine or chloroquine
- •7.Immunosuppressive conditions or medications
- •8.Pregnancy or breast feeding
- •9.Concurrent participation in other COVID-19 clinical trials
- •10.Inability to follow study procedures during the trial period
- •11.Inability to provide informed consent
- •12.Lack of fluency in the English language as this will impede the ability of the participant to interact with the web-based data collection platform
研究者
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