Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
试验速览
- 阶段
- 早期 1 期
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Clinical Condition
研究概览
简要总结
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.
详细描述
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.
We aim to demonstrate decrease in hospital related complications among ambulatory patients with mild COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.
Ambulatory patients on day 3 of symptoms and with confirmed diagnosis of COVID-19 will receive the treatment.
Patients that do not fulfill the inclusion/exclusion criteria or that is not willing to participate in the study will be invited to consent the use of their data as part of a "control" group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Informed consent from patient or legal representative.
- •Male or female, and:
- •aged ≥ 70 years; or
- •aged < 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension)
- •One or more mild symptoms characteristic of COVID-19 for 3 days, such as fever, cough and signs of respiratory distress, which do not require hospitalization.
排除标准
- •Participating in another RCT in the past 12 months;
- •Known allergy to HCQ or chloroquine
- •Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
- •Severely reduced LV function
- •Severely reduced renal function;
- •Pregnancy or breast feeding
- •Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
研究组 & 干预措施
HCQ + AZT
All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (00 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care.
干预措施: Hydroxychloroquine Sulfate (Drug)
HCQ + AZT
All patients included in the study will receive hydroxychloroquine (HCQ) 400 mg (00 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (AZT) (500 mg/ 5 days) on top of standard care.
干预措施: Azithromycin Tablets (Drug)
结局指标
主要结局
Change in Clinical Condition
时间窗: 28 days
Ordinal scale (7 points ordinal scale that measures illness severity over time)
次要结局
- Change in Clinical Condition(28 days)
- Rate of mortality within 28-days(28 days)
- Change in Clinical Condition related to comorbidity(28 days)
- Hospitalization(28 days)