PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.
研究概览
简要总结
This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2).
The participants will be randomised to receive either:
Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).
详细描述
This is an open label, superiority, cluster-randomized Italian interventional clinical trial, evaluating the role of Hydroxychloroquine versus observation only in preventing infection to COVID-19 or treating early phase COVID-19 patients.
Each index case is randomised to either Arm A: Hydroxychloroquine or Arm B: observation in a 2:1 ratio on an open label basis. Participants in the same cluster receive the same intervention.
Study population is constituted by:
Group 1: Severe Acute Respiratory Syndrome (SARS) - Corona Virus (CoV)-2-exposed subjects , as household members/contacts of COVID-19 patients.
Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female, aged >= 18 years
- •SARS-CoV-2-exposed subjects, as household members and/or contacts of COVID-19 patients (Group 1). In this group are included Health care professionals in contact with COVID-19 patients.
- •COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (Group 2)
- •Absence of any COVID-19 symptom in last week before randomization (fever >37.5°C, cough, dyspnea) (only for group 1 subjects)
- •Paracetamol treatment is accepted only for group
- •Participant is willing and able to give informed consent for participation in the study (either recorded during a telephonic interview or signed in person) and agrees with the study and its conduct.
排除标准
- •Reported anamnesis for:
- •Intolerance or previous toxicity for hydroxychloroquine/chloroquine
- •Bradycardia or reduction rhythm of heart with arrythmias
- •Ischemic heart disease
- •Retinopathy
- •Congestive heart failure under/with use of diuretics
- •Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Diabetes type 1
- •Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy.
- •Severe neurological and mental illness
- •Any other contraindication to take hydroxychloroquine
- •Already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks
- •Use of other antiviral agents in the last 3 weeks
- •Subject with a positive test for SARS-CoV-2 (for Group 1)
- •Pregnant or lactating
- •Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6
- •Known prolonged QT syndrome or current use of drugs with known QT prolongation
- •Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
研究组 & 干预措施
Group 1: Hydroxychloroquine
A loading dose Hydroxychloroquine 400 mg twice daily at day 1, followed by a weekly dose of Hydroxychloroquine 200 mg twice daily on days 8, 15 and 22, covering a total of 1 month of treatment.
干预措施: Hydroxychloroquine (Drug)
Group 2: Hydroxycloroquine
A loading dose Hydroxychloroquine 400 mg twice daily at day 1 followed by 200 mg twice daily for a total of at least 5-7 days according to clinical evolution.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.
时间窗: within 14 days from randomization
Group 2: The primary endpoint/outcome measure is the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.
the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.
时间窗: within 1 month from randomization
Group 1:The primary endpoint/outcome measure is the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.
次要结局
- The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms(within 1 month from randomization)
- The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.(within 14 days from randomization)
- Absolute and relative frequencies of Serious Adverse Events(up to 10 months)
- The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization(within 1 month from randomization)
- The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population(within 1 month from randomization)
- Variation in Quality of Life scores in different time points(up to 10 months)