EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Rate of patients reaching a significant hypoxemia, in each arms.
研究概览
简要总结
Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia
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 > 18 years old
- •Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab
- •CT scan suggestive of Sars-CoV-2 pneumonia
排除标准
- •Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab
- •Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family member
- •Long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin)
- •Retinopathy or maculopathy
- •Porphyria
- •Severe renal failure (GFR less than 30 mL/min/m²)
- •Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L)
- •Hypomagnesiemia, ie less than 0,7 mmol/L
- •Severe cholestasis, cirrhosis or severe hepatic failure
- •Known cardiac medical history of congestive heart failure or myocardial infarction
- •Bradycardia less than 50 beats per minute
- •Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders
- •Blood disorders with history of hematopoietic stem cells allograft
- •Known history of G6PD deficiency
- •Pregnancy
- •Breastfeeding
- •Subject protected by law under guardianship of curatorship
- •Inability to take oral medications
研究组 & 干预措施
Control
The patient is given antibiotics only. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc).
干预措施: Control arm (Drug)
Hydroxychloroquine
Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5).
Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc)
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine and Azithromycin
Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5).
Azithromycin is given for 5 days, with a loading dose of 500 mg at D1, and 250 mg for the next 4 days.
Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc) In case of moderate renal failure (glomerular filtration rate between 30 and 60 mL/min/m²), hydroxychloroquine dosage are lowered by half.
干预措施: Hydroxychloroquine and azithromycin treatment arm. (Drug)
结局指标
主要结局
Rate of patients reaching a significant hypoxemia, in each arms.
时间窗: From day 0 to day 7
A significant hypoxemia is an arterial partial pressure of oxygen of less than 60 mmHg despite an oxygen flow of more than 6 L/min, patient at rest.
次要结局
未报告次要终点