PACTR202009642148520招募中3 期
Malaria as a risk factor for COVID-19 in western Kenya and Burkina Faso
STM Liverpool School of Tropical Medicine0 个研究点目标入组 142 人开始时间: 2020年9月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)(—)
- 性别
- All
入选标准
- •Laboratory confirmed SARS-CoV-2 infection, with positive molecular test results within the past 72 hours*
- •Aged >=6 months **
- •Resident in the study area
- •The participant or caretaker is willing and able to give informed consent or assent with parent/guardian informed consent for participation in the study
- •Agrees not to self-medicate with chloroquine, hydroxychloroquine or other antimalarials with potential anti-SARS-CoV-2 properties
- •Not previously diagnosed with COVID-19
- •Contactable by phone for follow-up permitting real-time, reliable information
- •Uncomplicated malaria, defined as able to take oral medication
- •Bodyweight =5kg
- •Confirmed malaria infection by RDT (pLDH) or microscopy
排除标准
- •Unwilling or unable to provide informed consent/assent
- •The participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results
- •Inability/unlikely to be in the study area for the duration of the 28-day follow-up period
- •Pregnant or lactating women
- •Severe disease requiring parenteral treatment
- •Currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine
- •Received chloroquine in the last three days
- •Inability/unlikely to be in the study area for the duration of the 42-day follow-up period
- •Known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms
- •Known chronic kidney disease (signs or symptoms of stage IV renal impairment or receiving dialysis)
- •Known liver cirrhosis (Child-Pugh Class B or greater) or signs or symptoms of severe hepatotoxicity
研究者
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