Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2
研究概览
简要总结
The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical, and auxiliary staff.
- •Negative rapid serologic and molecular testing for SARS-CoV-
- •Written informed consent.
排除标准
- •Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste.
- •Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin.
- •Known cardiac disease or a history of prolonged QT syndrome.
- •Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
- •Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.
- •Other reported medical conditions, such as glucose-6-phosphate dehydrogenase deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances, that make study participation not in the individual's best interest.
研究组 & 干预措施
Hydroxychloroquine
Hydroxychloroquine prophylaxis plus standard measures of personal protection.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2
时间窗: Eight weeks
Safety: Proportion of participants with grade 3 or more adverse events
时间窗: Eight weeks
次要结局
- Tolerability: Proportion of participants that discontinue prophylactic treatment due to grade 1 or 2 adverse events(Eight weeks)