PROLIFIC ChemoprophylaxisTrial (COVID-19)
ChemoPROphyLaxIs For covId-19 Infectious Disease (the PROLIFIC Trial)
研究概览
地位
条件
详细说明
The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2 coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability of the entire National Health Service (NHS) to cope with the increased demand. The availability of personal protective equipment is limited and reports of high risk procedures such as aerosol generating procedures (e.g. intubation for the sickest patients) is a source of great concern for infection transmission. Frontline NHS staff with direct patient contact have the highest likelihood of exposure to SARS-CoV-2 and development of COVID-19 disease. Efforts to protect these workers from development of COVID-19, using drugs to prevent the disease, require urgent evaluation.
This trial will be a double-blind, randomized, placebo-controlled trial in a cohort of frontline healthcare workers, who will potentially be exposed to SARS-CoV-2. Eligible participants will be frontline NHS workers aged 18 to 70 years who work in a healthcare setting with direct patient care. Participants will be randomised to one of 3 arms and receive either: (1) Hydroxychloroquine Daily (loading phase: 800mg for first 2 days; maintenance phase: 1 x 200mg tablet every day) + weekly placebo; (2) Hydroxychloroquine weekly (loading phase: 800mg for first 2 days; maintenance phase: 2 x 200mg tablets every 7th day/weekly) + daily placebo, or (3) placebo (daily and weekly).
Participants will be reviewed at an interim visit 6 weeks after baseline and again and the end of the study treatment in 90 days (approximately 3 months) after randomization. Participants will also complete brief questions about their health weekly while on treatment (remotely, via app/web/phone-based interface).
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
-
Cambridge、英国、CB2 0QQ
- 招聘中
- Cambridge University Hospitals NHS Foundation Trust
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
To be included in the trial the participant MUST:
- Have given written informed consent to participate
- Be aged 18 years to 70 years
- Not previously have been diagnosed with COVID-19
- Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care
Exclusion Criteria:The presence of any of the following will mean participants are ineligible:
- Known COVID-19 positive test at baseline (if available)
- Symptomatic for possible COVID-19 at baseline
- Known hypersensitivity reaction to HCQ, chloroquine or 4-aminoquinolines
- Known retinal disease
- Known porphyria
- Known chronic kidney disease (CKD; eGFR<30ml/min)
- Known epilepsy
- Known heart failure or conduction problems
- Known significant liver disease (Gilbert's syndrome is permitted)
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Currently taking any of the following contraindicated medications:
- Digoxin
- Chloroquine
- Halofantrine
- Amiodarone
- Moxifloxacin
- Cyclosporin
- Mefloquine
- Praziquantel
- Ciprofloxacin
- Clarithromycin
- Prochlorperazine
- Fluconazole
- Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine
- Currently breastfeeding
- Unable to be followed-up during the trial
- Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit
- Not able to use or have access to a modern phone device/web-based technology
- Any other clinical reason which may preclude entry in the opinion of the investigator
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Hydroxychloroquine - Daily dosing
Hydroxychloroquine Daily (loading phase: 800mg for first 2 days; maintenance phase: 1 x 200mg tablet every day) + weekly placebo, for approximately 90 days. Route: Oral. Pharmaceutical form: Tablet |
Active HCQ: Days 1-2: Loading phase - 400mg (2 x 200mg capsules) taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 200mg (1 x 200mg capsule) taken ONCE A DAY, every day for 90 days (~3 months), Matched Placebo HCQ: Days 3 onwards: Maintenance Phase - 2 capsules taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (~3 months) |
|
有源比较器：Hydroxychloroquine - Weekly dosing
Hydroxychloroquine weekly (loading phase: 800mg for first 2 days; maintenance phase: 2 x 200mg tablets every 7th day/weekly) + daily placebo, for approximately 90 days. Route: Oral. Pharmaceutical form: Tablet |
Active HCQ: Days 1-2: Loading Phase - 400mg (2 x 200mg capsules) taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 400mg (2 x 200mg capsules) taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (~3 months) Matched Placebo HCQ: Days 3 onwards: Maintenance Phase - 1 capsule taken ONCE A DAY for 90 days (~3 months) |
|
安慰剂比较：Placebo
Placebo arm - 2 tablets twice daily for first 2 days (loading phase), followed by 1 tablet every day for 90 days plus 2 tablets every 7th day, for approximately 90 days. Route: Oral. Pharmaceutical form: Tablet |
Matched placebo HCQ - daily dosing: Days 1-2: Loading Phase - 2 capsules taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 1 capsule taken ONCE A DAY for 90 days (~3 months) Matched placebo HCQ - weekly dosing Days 3 onwards: Maintenance Phase - 2 capsules taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (~3 months) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to positive COVID-19 disease
大体时间：Assessed up to 90 days
|
Time taken for incidence of COVID-19 disease between Hydroxychloroquine and placebo arms
|
Assessed up to 90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of COVID-19 test positive cases
大体时间：Assessed up to 90 days
|
Number of COVID-19 symptoms based on clinical guidelines and test positive infections per study arm
|
Assessed up to 90 days
|
|
Number of COVID-19 serological test positive cases
大体时间：Assessed up to 90 days
|
Number of test positive COVID-19 serological test positive cases per study arm
|
Assessed up to 90 days
|
|
Severity of COVID-19 disease between each arm
大体时间：Assessed up to 90 days
|
Severity based on hospitalisation
|
Assessed up to 90 days
|
|
Number of common COVID-19 complications between each arm
大体时间：Assessed up to 90 days
|
Number of common COVID-19 complications between arms
|
Assessed up to 90 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.