Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Hospitalization
研究概览
简要总结
Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.
详细描述
In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines.
To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
- •Signed informed consent
排除标准
- •Retinal degeneration.
- •Congenital or acquired long QT syndrome.
- •Advanced liver failure.
- •Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute).
- •Allergic to hydroxychloroquine or azithromycin.
- •Serious interaction with the drugs used.
- •Pregnant or breastfeeding.
- •Men and women in fertile and sexually active periods, who do not accept a highly effective contraceptive method.
- •Inability to follow study procedures.
研究组 & 干预措施
Hydroxychloroquine + Azithromycin
Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0
Oral intake in all cases. Pills will be taken simultaneously.
干预措施: Hydroxychloroquine Pill + Azithromycin Pill (Drug)
SOC (Standard of Care)
SOC for symptoms treatment
Acetaminophen or Metamizole, 1-1-1 Antitussives if needed
干预措施: SOC (Drug)
结局指标
主要结局
Hospitalization
时间窗: From randomization until patient's hospitalization happens, assessed up to 28 days.
ICU admission
时间窗: From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
Death
时间窗: From randomization until death by any cause related to COVID19, assessed up to 28 days.
次要结局
- Clinical Evolution(From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.)