Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,652
- 试验地点
- 25
- 主要终点
- Number of symptomatic COVID-19 infections
研究概览
简要总结
The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites.
The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months.
If the participant is diagnosed with COVID-19, they will take continue to take the study medication until:
- 90 days after enrolment (i.e., completion of kit)
- hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or
- advised to stop by their healthcare professional for other reasons
Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.
This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines
- •Contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance < 10 ml/min
- •Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines, or history of these medications within the previous 7 days
- •Taking prohibited medications
- •Known retinal disease
- •Inability to be followed up for the trial period
- •Known prolonged QT syndrome (however ECG is not required at baseline)
- •Known pregnancy or women who are actively trying to become pregnant
- •Prior diagnosis of porphyria
- •Previously received any dose of COVID-19 vaccine
- •The investigator may consult the physician's guidance documents for any further questions regarding eligibility of potential participants.
- •Prohibited medications for the purpose of study enrollment include:
- •Antiarrhythmic medications: digoxin, amiodarone, sotalol, flecainide
- •Antiparasitic/malarial agents: mefloquine, halofantrine, praziquantel
- •Antibiotics: levofloxacin, moxifloxacin, ciprofloxacin, azithromycin, clarithromycin, erythromycin
- •Antifungal drugs: fluconazole, ketoconazole, itraconazole, terfenadine
- •Psychoactive drugs: lithium, quetiapine, chlorpromazine, thioridazine, ziprasidone, haloperidol, droperidol, methadone
- •Migraine treatment: sumatriptan
- •Antihistamines: astemizole
- •Antiemetics: prochlorperazine, metoclopramide
- •Cancer treatments: abiraterone, dabrafenib, dacomitinib, enzalutamide, idelalisib, mitotane
- •Other specific drugs: ciclosporin, conivaptan, agalsidase alfa or beta, mifepristone, stiripentol
- •PrincipaI Investigators will also be directed to crediblemeds.org to check other agents that may prolong QT interval
研究组 & 干预措施
Chloroquine or Hydroxychloroquine
In Asia, the participant will receive chloroquine.
In Europe, the participant will receive hydroxychloroquine
Specific drug allocation will be determined by country prior to activation based upon factors such as inventory availability and importation requirements
干预措施: Chloroquine or Hydroxychloroquine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of symptomatic COVID-19 infections
时间窗: Approximately 90 days
Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
次要结局
- Number of symptomatic acute respiratory illnesses(Approximately 90 days)
- Symptoms severity of COVID-19(Approximately 90 days)
- Number of asymptomatic cases of COVID-19(Approximately 90 days)
- Severity of symptomatic acute respiratory illnesses(Approximately 90 days)