Proactive Protection With Azithromycin and Hydroxychloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 117
- 试验地点
- 8
- 主要终点
- Number of Days Alive and Discharged From Hospital Within 14 Days
研究概览
简要总结
This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
详细描述
In the ongoing coronavirus pandemic, COVID-19, that arose in Wuhan China, there is still sparse data in the course, risk of various complications, and in particular how patients who are hospitalized are best treated to ensure high survival and short hospitalization. Despite the rapid spread of the disease globally, there is no solid data yet to recommend any specific treatments, which is why symptomatic, organ supportive therapy including respiratory therapy in acute pulmonary failure is recommended. There has been reported a high incidence of bacterial super-infections in patients with COVID-19. Patients with COVID-19 also have a higher risk of dying because of septic shock. Thus, there is an urgent need for treatment that can improve the patient's chance of the shortest hospitalization possible, and treatment that can lower the risk of secondary infection and death.
This is a randomized, placebo-controlled, double-blinded multi-center trial evaluating the effect of azithromycin and hydroxychloroquine treatment in patients with COVID-19 during hospitalization. The aim of the study is to investigate whether the treatment can shorten hospitalization, reduce the risk of non-invasive ventilation, admittance to Intensive Care Units and death.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to a Danish emergency department, lung medical department or medical department
- •Age >18 years
- •Hospitalized <48 hours
- •Positive COVID-19 test/diagnosis during the hospitalization
- •Signs informed consent
排除标准
- •If the patient uses > 5 LO2/min at time of recruitment
- •Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinolinderivates
- •Pregnancy
- •Breastfeeding
- •Neurogenic hearing loss
- •Psoriasis
- •Retinopathy
- •Maculopathy
- •Changes in vision field
- •Severe liver disease other than amoebiases
- •Severe gastrointestinal, neurological or haematological disorders
- •eGFR < 45 ml/min/1.73m2
- •Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval
- •Myasthenia Gravis
- •Uses Digoxin
- •Glucose-6-phosphate dehydrogenase deficiency
- •Porphyria
- •Hypoglycemia at any time since hospitalization
- •Severe mental illness which significantly impedes cooperation
- •Severe linguistic problems that significantly impedes cooperation
- •Treatment with sickle alkaloids
研究组 & 干预措施
Control
This arm will receive standard care and placebo in 15 days.
Azithromycin placebo:
Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1
Hydroxychloroquine placebo:
Day 1-15: 200 mg x 2
干预措施: Placebo oral tablet (Drug)
Intervention
This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.
Azithromycin:
Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1
Hydroxychloroquine:
Day 1-15: 200 mg x 2
干预措施: Azithromycin (Drug)
Intervention
This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.
Azithromycin:
Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1
Hydroxychloroquine:
Day 1-15: 200 mg x 2
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Number of Days Alive and Discharged From Hospital Within 14 Days
时间窗: 14 days
次要结局
- Days Alive and Discharged From Hospital(30 days)
- Change of pH in Blood(4 days)
- Mortality(365 days)
- Length of Hospitalization(14 days)
- Number of Readmissions (All Causes)(30 days)
- Change in Patient's Carbondioxide Partial Pressure(4 days)
- Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")(14 days)
- Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization(14 days)
- Change in Patient's Oxygen Partial Pressure(4 days)
- Categorization of Hospitalization Status(14 days)
- Length of Stay in ICU(14 days)
- Number of Days Using Non-invasive Ventilation (NIV)(14 days)