Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19: the Randomized, Double-blind, Phase III IMPACT-SIRIO 5 Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Death from any cause or need for intubation
研究概览
简要总结
The IMPACT-SIRIO 5 is a randomized, double-blind, phase III clinical trial aimed to evaluate safety and efficacy of PCSK9 inhibition on clinical outcome in patients during the inflammatory stage of the COVID-19. During the hospitalization participants will be randomized in a 1:1 ratio to either receive PCSK9 inhibitor (evolocumab) or to receive placebo (saline solution). Furthermore, all people included in the study will be treated in accordance to the latest recommendations on the treatment of patients infected with SARS-CoV-2.
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)
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
- •Written informed consent for participation in the study
- •Male and female age 18 or more at the time of signing the informed consent
- •SARS-CoV-2 infection confirmed by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
- •COVID-19 pneumonia with a typical radiological changes
- •PaO2/FIO2 ratio less than or equal to 300
- •COVID-19 Pneumonia in cytokine storm with elevated serum level of interleukin-6
排除标准
- •Use of fibrates other than fenofibrate or fenofibric acid
- •Known active infections or other clinical condition that contraindicate PCSK9 inhibitors
- •Known systemic hypersensitivity to PCSK9 inhibitors
- •Estimated glomerular filtration rate <30 ml/min/1.73 m2
- •Absolute neutrophil count (ANC) less than 2000/mm3
- •A platelet count less than 50000/mm3
- •Creatine kinase (CK) greater than 3x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3x upper limit of normal (ULN)
- •Not expected to survive for more than 48 hours from screening
- •Unrelated co-morbidity with life expectancy <3 months.
- •Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
- •Patient being treated with other immunomodulators (except for glucocorticoids).
- •Patient included in any other interventional trial.
研究组 & 干预措施
PCSK9 inhibitor (evolocumab)
140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations
干预措施: Evolocumab (Drug)
Usual Care
1 ml of 0,9% saline solution as a single subcutaneous injection. Patients will be treated in accordance to the latest recommendations on caring for patients infected with SARS-CoV-2.
干预措施: Saline solution (Drug)
结局指标
主要结局
Death from any cause or need for intubation
时间窗: during hospitalization, up to 30 days
Indication for intubation determined individually for each patient and clinical status
次要结局
- Days of intubation(during hospitalization, up to 30 days)
- Change in serum interleukin-6 concentration from day 0 to day 7 and day 30(7 and 30 days from randomization)
- Duration of hospital stay(during hospitalization, up to 30 days)
- Time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)(during hospitalization, up to 30 days)
- Death from any cause(during hospitalization, up to 30 days)
- Need for intubation(during hospitalization, up to 30 days)
- Duration of oxygen therapy(during hospitalization, up to 30 days)
研究者
Jacek Kubica
Head of Department of Cardiology and Internal Medicine
Collegium Medicum w Bydgoszczy