Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,483
- 试验地点
- 2
- 主要终点
- COVID-19-free Survival
研究概览
简要总结
Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
详细描述
The current standard of care is observation and quarantine after exposure to COVID-19. There is no approved treatment or prophylaxis for COVID-19.
As of March 6, 2020, the CDC estimates that the transmission of SARS-CoV2 after a U.S. household close contract is 10.5% (95%CI, 2.9 to 31.4%). Among all close contacts, the SARS-CoV2 transmission rate is estimated at 0.45% (95%CI, 0.12 to 1.6%) by the CDC. These estimates are based on monitoring of travel-associated COVID19 cases. Conversely, in a setting with community transmission, the secondary attack rate in China was 35% (95%CI, 27-44%) based on 48 transmissions among 137 persons in 9 index patients.
Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or reduce disease severity. It is not known at what dosing hydroxychloroquine may be effective for pre-exposure prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A healthcare worker at high risk for COVID-19 exposure (defined below):
- •Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
- •Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
- •Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
- •First responders (i.e. EMTs, paramedics)
排除标准
- •Active COVID-19 disease
- •Prior COVID-19 disease
- •Current fever, cough, shortness of breath
- •Allergy to chloroquine or hydroxychloroquine
- •Prior retinal eye disease
- •Known Chronic Kidney disease, Stage 4 or 5 or dialysis
- •Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- •Weight <40 kg
- •Prolonged QT syndrome
- •Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
- •Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.
研究组 & 干预措施
Intervention Once Weekly
400 mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg weekly for the duration of follow up, up to 12 weeks
干预措施: Hydroxychloroquine (Drug)
Intervention Twice Weekly
400mg orally once, followed by 400mg 6 to 8 hours later, thereafter 400mg twice weekly for the duration of follow up, up to 12 weeks
干预措施: Hydroxychloroquine (Drug)
Control Group
Placebo 2 tabs once, followed by 2 tabs 6 to 8 hours later, thereafter two tabs weekly or twice weekly for the duration of follow up, up to 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
COVID-19-free Survival
时间窗: up to 12 weeks
Outcome reported as the number of participants in each arm who are COVID-19-free at the end of study treatment.
次要结局
- Incidence of Possible COVID-19 Symptoms(up to 12 weeks)
- Incidence of All-cause Study Medicine Discontinuation(up to 12 weeks)
- Ordinal Scale of COVID-19 Disease Maximum Severity if COVID-19 Diagnosed at Study End(up to 12 weeks)
- Number of Confirmed SARS-CoV-2 Detection(up to 12 weeks)
- Incidence of Hospitalization for COVID-19 or Death(up to 12 weeks)
- Incidence of Possible Study Medication-related Side Effects(up to 12 weeks)