Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 in A Two Staged, Multicenter, Open Label and Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- change in virus duration (viral shedding)
研究概览
简要总结
19 COVID (Coronavirus disease 2019 ) is a deadly viral disease that has been spreading around the world for several months, and is caused by a CORONA family virus (COVID-19). Following IN-VITRO evidence of the antiviral effect of CHLOROQUINE in CORONA viruses, this drug has been used empirically for COVID-19 patients and is currently recommended in Israel for the treatment of intermediate and severity disease.
The mechanism of action of chloroquine is in part by inhibiting the virus distribution, and changing the intracellular acidity, the virus distribution site. The intracellular chloroquine concentration is determined by a pump called PGP (permeability glycoprotein) that removes the drug from the cell and is activated by the drug. In the treatment of malaria, the benefit of low dosage of the drug has been shown to be effective due to the fact that the intracellular concentration of the drug is probably higher, and therefore the logic to examine this issue in COVID-19 treatment.
The purpose of this study is to test whether a low dose of Chloroquine will reduce the duration of the viral shedding and prevent the disease from worsening.
详细描述
19 COVID is a deadly viral disease that has been spreading around the world for several months, and is caused by a CORONA family virus (COVID-19). This virus family causes upper respiratory tract disease and sometimes severe and fatal lung disease, as in the past: SARS-CoV (severe acute respiratory syndrome) and -MERS-CoV.
Since the outbreak of the pandemic there has been a constant search for effective drug treatment for the disease. Following IN-VITRO evidence of the antiviral effect of CHLOROQUINE in CORONA viruses, this drug has been used empirically for COVID-19 patients and is currently recommended in Israel for the treatment of intermediate and severity disease.
Currently, it is not common to treat patients with mild illness or asymptomatic carriers. In these situations, isolation is recommended until upper respiratory tract surfaces no longer show the presence of the virus, a period of approximately 20 days. .
The mechanism of action of chloroquine is in part by inhibiting the virus distribution, and changing the intracellular acidity, the virus distribution site. The intracellular chloroquine concentration is determined by a pump called PGP that removes the drug from the cell and is activated by the drug. In the treatment of malaria, the benefit of low dosage of the drug has been shown to be effective due to the fact that the intracellular concentration of the drug is probably higher, and therefore the logic to examine this issue in COVID-19 treatment.
The purpose of this study is to test whether a low dose of Chloroquine will reduce the duration of the viral shedding and prevent the disease from worsening. Reducing the duration of viral shedding, shortens the time when there is a risk that the person will spread the disease, and the time when the person is in isolation and cannot return to his normal life.
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
- 否
入选标准
- •Age over 18
- •A person diagnosed with COVID-19 in the past 48 hours
- •Asymptomatic
排除标准
- •chronic lung disease with chronic hypoxia
- •Sleep apnea requiring BIPAP / continuous positive airway pressure
- •Retinal disease
- •Porphyria
- •Myastenia gravis
- •immunodeficiency disorders
- •Hearing Disorders
- •Scheduled for general anesthesia
- •treatment with antibiotics or antiretroviral for any reason
- •Pulse <50
- •Known Ventricular arrhythmias
- •Heart Failure: Systolic or Diastolic
- •kown QT prolongation
- •Taking medicines that increase the risk of QT prolongation in combination with CHLOROQUINE.
研究组 & 干预措施
low dose chloroquine
oral chloroquine 125mg daily for 7 days (or until the condition worsens, whichever comes first)
干预措施: chloroquine (Drug)
Regular dose chloroquine
oral chloroquine 500 mg twice daily for 7 days (or until the condition worsens, whichever comes first)
干预措施: chloroquine (Drug)
Standard of care
The treatment is mostly supportive in character and is given, based on patient's clinical state. Antibiotics do not help patients fight novel coronavirus.
干预措施: standard care (Other)
结局指标
主要结局
change in virus duration (viral shedding)
时间窗: 23 days
change in the extent and duration of virus shedding.
change in the number of patients going from asymptomatic to moderately disease
时间窗: 1 month
change in the number of patients going from asymptomatic to moderately disease
次要结局
未报告次要终点
