Atorvastatin in Hospitalized COVID-19 Patients: A Randomized, Double-blinded, Placebo-Controlled, Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
This randomized placebo-controlled double-blinded clinical trial aims to test the efficacy of administering atorvastatin 40 mg to hospitalized COVID-19 patients for 28 days on the all-cause 28-day mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients, caregivers, data collectors, and data analysts will be blinded for the study group. The Delta Pharma company (Egypt) will provide the atorvastatin and a similar placebo. The company will not participate in any step of the study including participant recruitment, data collection, data analysis, or results reporting. The company will prepare a similar package of drug and placebo (labeled as A and B). Even the pharmacist involved in treatment allocation will not know what is the treatment group, just A or B. For emergency unmasking, one of the directors of the COVID19 research council, who will not participate in the study, will know the true labels and the randomization table.
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
- •We will include adult patients (≥18 years old) with severe and critical COVID19 admitted to the COVID19 Mansoura University isolation hospital. We will include patients who are PCR-confirmed, clinically or radiologically diagnosed with COVID
- •Cases are defined as severe or critical according to the WHO definition (19); where critical cases have ARDS, or sepsis, septic shock or pulmonary embolism, acute coronary syndrome, or acute stroke, while severe cases have the clinical signs of severe pneumonia and SpO2 <90% on room air, or RR <30 breaths/min without any critical criteria.
排除标准
- •chronic statin use, serum creatine kinase (sr CK) > 5 times the upper limit of normal (ULN), serum transaminases > 5 times ULN, acute hepatic failure, chronic liver disease (Child-Pugh Classification C), history of rhabdomyolysis or myopathies, severe renal impairment not receiving renal replacement therapy (estimated Cr cl< 30 ml\min ), pregnant and lactating women, patients who are expected to die within 48 hours, or patients on chronic colchicine, cyclosporines, or ritonavir.
研究组 & 干预措施
Atorvastatin
All patients will be randomized to receive atorvastatin 40 mg once daily orally for a maximum of 28 days. All patients will receive the standard of care according to recent local hospital protocol. Antiviral treatment will be allowed and will be reported.
Administration in unconscious or ventilated patients: The patients will receive the drug (divided into 4 quadrants) through a nasogastric tube.
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
Control
All patients will be randomized to receive the placebo once daily orally for a maximum of 28 days. All patients will receive the standard of care according to recent local hospital protocol. Antiviral treatment will be allowed and will be reported.
Administration in unconscious or ventilated patients: The patients will receive the drug through a nasogastric tube.
Placebo will resemble the original drug as regards the drug package, the tablet color, consistency, and size.
干预措施: Placebo (Other)
结局指标
主要结局
mortality
时间窗: 6 months after randomization
all-cause mortality
次要结局
- Intensive Care length of stay(28 days or primary hospital stay)
- acute kidney injury(28 days or primary hospital stay)
- incidence of invasive mechanical ventilation (IMV)(28 days or primary hospital stay)
- duration of invasive mechanical ventilation (IMV)(28 days or primary hospital stay)
- Time to clinical improvement(28 days or primary hospital stay)
- Hospital length of stay(through study completion, an average of 9 months)
- serious adverse effects(28 days after start of the drug)
- status at hospital discharge(through study completion, an average of 9 months)