Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).
研究概览
简要总结
Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.
详细描述
The multi-centre COVIDOC study will evaluate the efficacy and safety of the use of hydroxychloroquine (10 days) combined with azithromycin (5 days) compared to hydroxychloroquine (10 days) in the the clinical evolution by the ordinal scale of 7 points in adults hospitalized outside Intensive care unit with pneumonia caused by infection by the SARS-CoV2 virus in France.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised in the 96 h before randomization
- •Beginning of COVID-19 symptoms < 10 days at the time of randomization
- •Presence of symptom(s) of COVID-19 : fever (température > or = 37,5°C) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia
- •Presence of TDM/radiographic signs or pneumonia
- •Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy)
排除标准
- •Absence of signed informed consent
- •SpO2 < 90 % ambient air or < 94 % with oxygenotherapy > or = 3l/min
- •Need of oxygenotherapy > 6 l/min or mechanical ventilation
- •Need of hospitalization in ICU
- •ALAT/ASAT > 5 LSN
- •Renal failure (eGFR < 40 ml/min ) or dialysis
- •Pregnancy or breastfeeding
- •Retinopathy
- •Known deficit in G6PD
- •Cardiac rythm / lengthening QT disorders
- •QT space lengthening on ECG with QTc > 450 ms
- •Concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine, anti-arhythmic class IA & III, antidepressive drugs,..
研究组 & 干预措施
monotherapy hydroxychloroquine
Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5
干预措施: Hydroxychloroquine + placebo (Drug)
combination hydroxychloroquine + azithromycin
Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) and azithromycin 500mg (Day 1 ), 250 mg (from day 2 to Day 5)
干预措施: hydroxychloroquine + azithromycin (Drug)
结局指标
主要结局
Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).
时间窗: up to Day 11
Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)
次要结局
- Occurence of grade 3-4 adverse event(up to Day 29)
- Length of hospital day(up to Day 29)
- Hospital Mortality(Day 29)
- Need to Mechanical Ventilation(up to Day 29)
- Clinical status assessed by ordinal scale(up to Day 29)
- transfer to ICU(up to Day 29)
- QTc Lengthening(up to Day 11)
- Evolution of pulmonary CT scan images(up to Day 11)