Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- COVID-19 Seroconversion rate
研究概览
简要总结
Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.
详细描述
Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be masked to study assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthcare worker at risk of Covid-19
排除标准
- •Known hypersensitivity or allergic reactions to 4-aminoquinoline compounds or its ingredients.
- •Current, or history of, ocular macular disease or retinal damage.
- •Current, or history of, subnormal glomerular filtration.
- •Current use of tamoxifen citrate.
- •Current, or history of, cardiomyopathy, atrial, nodal, or ventricular arrhythmias, torsades de pointes, conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy.
- •Subjects taking other drugs that have the potential to prolong QT interval if taken with HCQ.
研究组 & 干预措施
Hydroxychloroquine
Oral loading dose of 800 mg followed by once weekly oral hydroxychloroquine 400 mg for 3 months
干预措施: Hydroxychloroquine (Drug)
Vitamin C
Oral Vitamin C 1,000 mg daily for three months
干预措施: Vitamin C (Other)
结局指标
主要结局
COVID-19 Seroconversion rate
时间窗: 3 months
Percentage of healthcare worker who develop antibodies to SARS-CoV-2
次要结局
- Admission for Covid-19(3 months)
研究者
Adam Singer
Professor and Vice Chairman for Research
Stony Brook University