Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
研究概览
简要总结
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
详细描述
This study will utilize a randomized, placebo-controlled, double-blinded design. Patients admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on CT/CXR, age >65, diabetes, hypertension, BMI > 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.
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
- Double (Participant, Investigator)
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
- •Admitted to Wellstar Kennestone Hospital
- •Age 18 years or older
- •Laboratory-confirmed COVID-19
- •At least 1 of the following:
- •Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
- •Bilateral infiltrates on CXR or CT of chest
- •Age 65 or older
- •Hypertension
- •Chronic lung disease
- •Cardiovascular disease
- •Chronic kidney disease
- •Cancer (hematologic malignancies, lung cancer, and metastatic disease)
排除标准
- •Unable to provide informed consent
- •Unable to take oral medication
- •Severe/critical COVID-19 disease at presentation
- •Intensive care or intermediate care required at admission or within 48 hours
- •Requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours
- •Likelihood of survival <48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission
- •Inability to take hydroxychloroquine due to allergy, QTc > 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions
- •Pregnant or breastfeeding
- •Severe liver disease (Child-Pugh Class C)
研究组 & 干预措施
Hydroxychloroquine
干预措施: Hydroxychloroquine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
时间窗: 30 Days
The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.
次要结局
- Incidence of QTc >500ms after initiation of therapy(30 Days)
- Incidence of discontinuation of therapy(30 Days)
- Resolution of Symptoms(14 Days)
- 30-Day Mortality(30 Days)
- Hospital length of stay(30 Days)