Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - SEVERE - Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 57
- 主要终点
- Evaluation of the clinical status
研究概览
简要总结
The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.
详细描述
The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract that is now spreading to several countries in the world, including Brazil. Mortality rates after infection are higher in adults over 60 and with a history of comorbidities. The most serious patients need care in intensive care units (ICU). Most of the time they depend on mechanical ventilation support due to acute respiratory distress syndrome (ARDS). Infection rates are higher than the capacity for intensive care, which represents a serious problem in medical care. Around 20% of those infected have severe pneumonia and so far it does not have a specific therapy, or even, an effective clinical management. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. A recent, small, non-randomized study with hydroxychloroquine in 36 patients infected with SARS-Cov-2 proved to be promising in the ability to reset the viral load in 6 days after starting treatment. Thus, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in the clinical evolution by the ordinal scale of 6 points in adult patients hospitalized with pneumonia caused by infection by the SARS-CoV2 virus in Brazil.
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
- •Males and females aged > 18 years;
- •Suspected or confirmed infection by SARS-CoV2;
- •Presenting with one of the following:
- •Need for oxygen supplementation > 4 L/min, or
- •Need for high-flow nasal canula, or
- •Need for non-invasive ventilation, or
- •Need for mechanical ventilation.
排除标准
- •Refusal to provide written informed consent (either the patient or a legal representative);
- •Hypersensitivity to any of the drugs used in the study (Azithromycin or Hydroxychloroquine);
- •Patients with more than 48 hours of prior study medication use;
- •Patients with onset of symptoms longer than 14 days;
- •Patients with long QT syndrome or severe ventricular arrhythmias, not protected by an implantable cardioverter defibrillators (ICD).;
- •QTc>= 480ms;
- •Do not resuscitate order or exclusive palliative care;
- •Patients with liver disease or cirrhosis or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase -ALT and aspartate aminotransferase - AST);
- •Patients with known retinopathy or macular degeneration;
- •Patients with history of pancreatitis;
- •Patients with concomitant use of medications that alter the absorption or excretion of azithromycin or hydroxychloroquine;
- •Breastfeeding women;
研究组 & 干预措施
Hydroxychloroquine + azithromycin
Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]
干预措施: Hydroxychloroquine + azithromycin (Drug)
Hydroxychloroquine
Hydroxychloroquine [400mg 2x/day, 12/12h]
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Evaluation of the clinical status
时间窗: 15 days after randomization
Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)
次要结局
- Time from treatment start to death(29 days after randomization)
- Number of days free from mechanical ventilation(29 days after randomization)
- Assess whether the tested therapies may be affected by leucocyte phenotype(Baseline)
- All-cause mortality(29 days after randomization)
- Evaluation of the clinical status(7 and 29 days after randomization)
- Duration of mechanical ventilation(29 days after randomization)
- Duration of hospitalization(29 days after randomization)
- Other secondary infections(29 days after randomization)
- Medium and long-term outcomes of SARS-CoV2 infection on morbimortality, daily life activities, mental health, and quality of life(3, 6, 9 and 12 months)