Post-exposure Prophylaxis or Preemptive Therapy 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
- 1,312
- 试验地点
- 5
- 主要终点
- Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline
研究概览
简要总结
Study Objective:
- To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.
- To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
详细描述
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care. Therapy is generally not given to persons who are not hospitalized. The doses of hydroxychloroquine being used are within the normal standard FDA-approved doses.
Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or early preemptive therapy may decrease disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis to prevent disease or preemptive therapy for those with early symptoms. People around the the United States and Canada can participate to help answer this critically important question. No in-person visits are needed.
This trial is targeting 5 groups of people NATIONWIDE to participate:
- If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR
- If you live with someone who has been diagnosed with COVID-19, with your last exposure within the last 4 days, and do not have any symptoms; OR
- If you live with someone who has been diagnosed with COVID-19, and your symptoms started within the last 4 days; OR
- If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days and do not have symptoms; OR
- If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days AND have compatible symptoms starting within the last 4 days;
You may participate if you live anywhere in the United States (including territories) or in the Canadian Provinces of Quebec, Manitoba, Alberta, or Ontario.
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
- •Provision of informed consent
- •Exposure to a COVID19 case within 4 days as either a household contact or occupational exposure, OR
- •Symptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR symptomatic high risk exposure with known COVID19 contact and within 4 days of symptom onset;
排除标准
- •Current hospitalization
- •Allergy to hydroxychloroquine
- •Retinal eye disease
- •Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- •Known chronic kidney disease, stage 4 or 5 or receiving dialysis
- •Structural or ischemic heart disease
- •Personal or Family History of Prolonged QT syndrome
- •Weight < 50 kg
- •Known Porphyria
- •Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal, sotalol;
- •Current use of medicines which prolong the QT interval including:
- •Antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, itraconazole, or mefloquine
- •Antidepressants: amitriptyline, citalopram, desipramine, escitalopram, imipramine, doxepin, fluoxetine, wellbutrin, or venlafaxine
- •Antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine, thioridazine, ziprasidone
- •Methadone
- •Sumatriptan, zolmitriptan
研究组 & 干预措施
Treatment
Participants in this arm will receive the study drug.
干预措施: Hydroxychloroquine (Drug)
Placebo
Participants in this arm will receive a placebo treatment.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline
时间窗: baseline and 14 days
Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline
时间窗: 14 days
Number of participants at 14 days post enrollment with active COVID19 disease among those who were asymptomatic at baseline.
次要结局
- Rate of Hospitalization(14 days)
- Rate of Death(Approximately 30 days)
- Rate of Confirmed SARS-CoV-2 Detection(14 days)
- Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)(14 days)
- Rate of All-Cause Study Medicine Discontinuation or Withdrawal(14 days)
- Overall Symptom Severity at 5 and 14 Days(5 and 14 days)
- Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry(14 days)