NCT04350450撤回2 期
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to resolution of symptoms
研究概览
简要总结
Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect clinical symptoms)
- •Call into office within the first 7 days of illness
- •Have any of the following high risk conditions:
- •HTN, CAD, or chronic heart disease
- •Chronic kidney disease
- •Chronic lung disease
- •Active or recent chemotherapy for malignancy
- •Organ transplant
- •Taking Immune-suppressing medications
- •HIV with CD4 <200 cells/mm3
- •Experiencing at least one of the following high risk symptoms:
- •Severe cough
- •Fever 100.0F or greater
- •Shortness of Breath
排除标准
- •HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ
研究组 & 干预措施
Treatment Group
Experimental
Eligible participants will be offered the standard Montefiore HCQ dosing regimen of 400mg every 12 hours x 24 hours, then 400mg daily for remaining 4 days and complete a survey study
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Time to resolution of symptoms
时间窗: up to 4 weeks
Time that it takes for symptoms to be resolved in those who were treated vs untreated
次要结局
- Rate of hospital admission in treated and untreated healthcare workers(up to 4 weeks)
- Number of days from onset of illness to symptom resolution(up to 4 weeks)
- Number of days to return to work(up to 4 weeks)
- Adverse effect of HCQ during treatment(up to 5 days)
研究者
Priya Nori
Principal Investigator
Montefiore Medical Center
研究点 (1)
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