Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Symptomatic COVID(+) infection rate
研究概览
简要总结
Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study
详细描述
Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo
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
- Single (Outcomes Assessor)
盲法说明
As the trial is open-label and to preserve the validity of the trial, the measurement of the endpoint must be blinded by a third party (i.e., an evaluator who is not aware of the arm to which the patient has been assigned or the treatment the patient is receiving) using the PROBE ("Prospective Randomized Open Blinded Endpoint") method.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of COVID-19 (-)
- •Works in a medical intensive care unit exposed to COVID-19 infection
- •18 years old < age < 65 years old
- •Having given written consent for their participation in the study.
排除标准
- •Diagnosis of COVID-19+
- •Retinopathies,
- •Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study.
- •Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug,
- •Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance < 30 ml/min.
- •Inability to be monitored during the trial period
- •Pregnancy and breastfeeding
- •Psoriasis
研究组 & 干预措施
Hydroxychloroquine (HCQ)
Exposed health care professionals working in the intensive care unit
干预措施: Hydroxychloroquine (HCQ) (Drug)
Placebo
Exposed health care professionals working in the intensive care unit
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Symptomatic COVID(+) infection rate
时间窗: 60 days
* Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: * Cough * Dyspnea * Fever * Myalgia * Arthralgia * Rhinorrhea * Anosmia * Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. * Biological Examination : * Measurement of viral load * Ion, liver, kidney, haematological assessment * Electrical Examination: ECG
次要结局
未报告次要终点
研究者
Dr Jalila Ben Khelil
Head of department
Abderrahmane Mami Hospital