Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Number patients developing severe infection or death
研究概览
简要总结
This is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.
详细描述
Inclusion criteria:
- Adult patients (>18 years)
- Confirmed COVID-19 infection by real-time PCR from a respiratory or other body sample within 48 hours of testing.
- Mild to moderate infection or asymptomatic patients with comorbidities: Symptomatic patients with fever >37.9ºC or cough or dyspnea or chest pain, not fulfilling severity exclusion criteria. We will include patients regardless of time since symptom onset. In addition, we will include asymptomatic patients with comorbidities including cardiac, pulmonary, diabetes, chronic renal failure or liver disease (definitions in Appendix 1) hospitalized for observation.
- Informed consent from patient or legal representative
Exclusion criteria:
- Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.
- Unable to take oral medication
- Known allergy to HCQ or chloroquine
- Prolonged QT, defined as QTc ≥450 milliseconds for men and as QTc ≥470 for women
- Severely reduced LV function (Ejection fraction<30%)
- Retinopathy
- Pregnancy or breast feeding
- Concomitant treatment with azithromycin, flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, pimozide.
- Chronic chloroquine/ HCQ treatment (within 1 month)
- Need for hemodialysis
- Participating in another RCT for treatment of COVID-19 Patients who meet eligibility criteria will be randomized in a 1:1 ration. Randomization will be done using a computer-generated list of random numbers allocated centrally through a web site, stratified by hospital. The random sequence will include random permuted blocks of 4 The intervention group will receive oral hydroxychloroquine. In the first day 400 mg twice daily, followed by 200mg twice daily on days 2-10 (continued after discharge if discharged before day 10).
The control group will not receive hydroxychloroquine. Physicians will be allowed to provide other medications at their discretion. For patients in the control group who develop severe disease (as defined), the physician will be allowed to use HCQ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Adult patients (>18 years)
- •Confirmed COVID-19 infection by real-time PCR from a respiratory or other body sample within 48 hours of testing.
- •Mild to moderate infection or asymptomatic patients with comorbidities: Symptomatic patients with fever >37.9ºC or cough or dyspnea or chest pain, not fulfilling severity exclusion criteria. We will include patients regardless of time since symptom onset. In addition, we will include asymptomatic patients with comorbidities including cardiac, pulmonary, diabetes, chronic renal failure or liver disease hospitalized for observation.
- •Informed consent from patient or legal representative.
排除标准
- •Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.
- •Unable to take oral medication
- •Known allergy to HCQ or chloroquine
- •Prolonged QT, defined as QTc ≥450 milliseconds for men and as QTc ≥470 for women
- •Severely reduced LV function (Ejection fraction<30%)
- •Retinopathy
- •Pregnancy or breast feeding
- •Concomitant treatment with azithromycin, flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, pimozide.
- •Chronic chloroquine/ HCQ treatment (within 1 month)
- •Need for hemodialysis
- •Participating in another RCT for treatment of COVID-19
研究组 & 干预措施
The intervention group
The intervention group will receive oral hydroxychloroquine. In the first day 400 mg twice daily, followed by 200mg twice daily on days 2-10 (continued after discharge if discharged before day 10).
干预措施: Hydroxychloroquine (Drug)
The control group
The control group will not receive hydroxychloroquine.
干预措施: The control group will not receive hydroxychloroquine (Other)
结局指标
主要结局
Number patients developing severe infection or death
时间窗: within 28 days
Number patients developing severe infection or death
次要结局
未报告次要终点