Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Ordinal Scale of COVID19 Disease Severity at 14 days
研究概览
简要总结
Study Objective:
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. Therapy is generally not given to persons who are not hospitalized.
Hydroxychloroquine may have antiviral effects against SARS-CoV2 which may decrease disease severity when given early. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide preemptive therapy for those with early symptoms.
This study is a continuation of NCT04308668 which looked at post-exposure prophylaxis (now closed) and early treatment in the USA (now closed, data to be pooled) and Canada (which continues in this study). On April 28, 2020 NCT04308668 changed its primary outcome to symptomatic improvement in the preemptive therapy arm. This study continues enrollment for the primary ordinal outcome of hospitalization; hospitalization with intensive care stay; or death.
People in the participating Canadian provinces can help answer this critically important question. No in-person visits are needed.
The doses of hydroxychloroquine being used have been approved by Health Canada.
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
- •Age 18 years of age or older AND provision of informed consent
- •Symptomatic COVID-19 disease with confirmed diagnosis with PCR+ SARS-CoV-2 within <= 4 days of symptoms
- •Healthcare worker with compatible symptoms with exposure to known PCR+ case <= 14 days (and no available/pending testing for the individual).
排除标准
- •Current hospitalization
- •Allergy to chloroquine or hydroxychloroquine
- •Severe diarrhea and/or vomiting
- •Significant hepatic impairment defined as known cirrhosis with history of hepatic encephalopathy or ascites.
- •Prior retinal eye disease
- •Concurrent malignancy requiring chemotherapy
- •Known Chronic Kidney disease, Stage 4 or 5 or dialysis.
- •Known glucose-6 phosphate dehydrogenase (G6PD) deficiency.
- •Known ventricular arrythmia, known prolonged QTc interval, or any known episode of sudden cardiac death
- •Known Porphyria
- •Weight <40 kg
- •Known Pregnancy of Breastfeeding
- •Current use of chloroquine or hydroxychloroquine
- •Current use of Artemether, Dapsone, Lumefantrine or Mefloquine
- •Current use of Cardiac medicines: amiodarone, digoxin, dofetilide, flecainide, procainamide, sotalol, or propafenone
- •Current use of the following antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, or itraconazole
- •Current use of the following antidepressants: amitriptyline, citalopram, desipramine, escitalopram, imipramine, doxepin, fluoxetine, sertraline, bupropion (Wellbutrin), or venlafaxine
- •Current use of the following antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine, thioridazine, ziprasidone
- •Current use of methadone
- •Current use of Sumatriptan, Zolmitriptan other than "as needed"
- •Current use of systemic chemotherapy
研究组 & 干预措施
Treatment
Participants in this arm will receive the study drug, hydroxychloroquine.
干预措施: Hydroxychloroquine (Drug)
Placebo
Participants in this arm will receive a placebo treatment.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Ordinal Scale of COVID19 Disease Severity at 14 days
时间窗: 14 days
Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
次要结局
- Incidence of All-Cause Study Medicine Discontinuation or Withdrawal(14 days)
- Overall change in disease severity over 14 days among those who are symptomatic at baseline(14 days)
- Overall symptom severity at 5 and 14 days(5 and 14 days)
- Incidence of Hospitalization(14 days)
- Incidence of COVID-19 related Death(90 days)
- Incidence of all-cause Death(90 days)
研究者
Todd C. Lee MD MPH FIDSA
Associate Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre