Prospective Randomized Open-label Trial of Atorvastatin as Adjunctive Treatment of COVID-19
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death
研究概览
简要总结
Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.
详细描述
COVID-19 is caused by SARS-CoV-2, a β-coronavirus that binds to the zinc peptidase angiotensin-converting enzyme 2 (ACE2). No drug is licensed to treat COVID-19, but adjunctive pharmacologic interventions have been proposed for their immunomodulatory effects, including statins. About 5% of cases are considered critical, with severe respiratory failure as well as myocarditis, and thromboses, and are associated with high fatality rate. Statins affect endothelial dysfunction and have anti-inflammatory and immunomodulatory effects.
This prospective, randomized, open-label trial of atorvastatin as adjunctive treatment of COVID-19 in hospitalized patients aims to study:
- Will atorvastatin reduce progression to severe or critical COVID-19 disease and death compared to standard care?
- Will atorvastatin lead to improved clinical outcome of COVID-19 disease at 30 days compared to standard care?
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18-85 years, admitted with suspected COVID-19 disease based on clinical criteria (typical upper respiratory symptoms, e.g. runny nose, sore throat, dry cough, associated with COVID-19 infection).
排除标准
- •already on chronic statin therapy, known hypersensitivity or adverse events to statins, negative nasopharyngeal (NP) swab for SARS-CoV-2, pregnancy and lactation, need for ICU admission, ALT or AST >2X upper limit of normal; CPK > 5x upper limit of normal; and creatinine clearance <50%, chronic treatment with colchicine, cyclosporin, digoxin, fusidic acid, azole antifungals, niacin.
研究组 & 干预措施
Treatment
40 mg
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death
时间窗: 30 days
Proportion of patients in each arm that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death, as described by WHO Ordinal Scale for Clinical Improvement scores 5-8 with higher being worse.
次要结局
- Overall score of patients in each arm on Day 7 based on WHO Ordinal Scale for Clinical Improvement(7 days)
- Overall score of patients in each arm on Day 30 based on WHO Ordinal Scale for Clinical Improvement(30 days)
- Proportions of patients in each arm who test negative for SARS-CoV-2 on Day 7(7 days)