The Use of a Mineralocorticoid Receptor Antagonist (Spironolactone) in the Treatment of Pulmonary Fibrosis Associated With SARS-CoV-2 Infection
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mechanical ventilation
研究概览
简要总结
In December 2019 SARS-CoV-2 virus appeared in the world, mainly appearing as an acute infection of the lower respiratory tract. In March 2020, the World Health Organization (WHO) announced a pandemic in relation to the disease caused by the SARS-CoV-2 virus, known as COronaVIrus Disease 2019 (COVID-19). Since then, the efforts of scientists from around the world have focused on finding the right treatment and vaccine for the new disease. COVID-19 has spread rapidly in a few months, affecting patients in all ages. The disease has a varied course, patients can be 80% asymptomatic, but many develop respiratory failure, complicated by sepsis and ultimately death. One of the possible complications associated with COVID-19 lung involvement is pulmonary fibrosis, leading to chronic breathing difficulties and prolonged disability. No specific mechanisms leading to this phenomenon have been identified in COVID-19, but some information is derived from previous studies on the SARS and MERS epidemic. There have been several reports that the use of spironolactone may be important in preventing pulmonary fibrosis.
The aim of the study is to evaluate the effectiveness of intravenous form of mineralocorticoid receptor antagonist canrenoate potassium (an aldosterone antagonist of the spirolactone group) in the treatment of COVID-19-associated pulmonary fibrosis based on the mechanisms of the immune response.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, 18-90 years of age.
- •Patient requiring oxygen therapy, SpO2 <94%.
- •Confirmed COVID-19 infection.
- •At least one risk factor for increased mortality in the course of COVID-19: currently published in the literature e.g. smoking, hypertension, diabetes, cardiovascular disease.
- •Documented informed consent according to ICH-GCP and national regulations.
排除标准
- •Chronic bronchitis, emphysema, interstitial lung disease, or other history of lung disease.
- •Contraindications to the use of spironolactone.
- •Hypersensitivity to spironolactone or any of the excipients.
- •Pregnant patients (pregnancy test will be performed in every patient of reproductive age) and during lactation.
- •Patients with mental illness or dementia who are unable to give informed consent to the examination.
- •ARDS caused by another viral infection (SARS-CoV-2 negative).
- •ARDS from other causes/trauma.
- •Ionic disorders: hyperkalemia, hyponatraemia.
- •Adrenal crisis.
- •Acute and chronic renal failure, creatinine clearance less than 30 ml/min.
研究组 & 干预措施
Canrenoate potassium
Administration of 200 mg of potassium Canrenoate potassium dissolved in 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
干预措施: Canrenoate Potassium (Drug)
Placebo
Administration of 100 ml of 0.9% sodium chloride intravenously twice a day for 7 days.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Mechanical ventilation
时间窗: 30 days
Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy
Passive oxygen therapy
时间窗: 30 days
Duration of passive oxygen therapy
次要结局
- Lung ultrasound_7(7 days)
- Chest CT(90 days)
- Lung ultrasound_30(30 days)
- Mortality_30(30 days)
- IL-1β level change.(7 days)
- Mortality_90(90 days)
- ICU LOS(30 days)
- IL-2 level change.(7 days)
- IL-6 level change.(7 days)
- IL-33 level change.(7 days)
- TNFα level change.(7 days)
- 6MWT(30 days)
- Hospital LOS(90 days)
研究者
Katarzyna Kotfis
Primary Investigator
Pomeranian Medical University Szczecin