Endothelial Protection in Convalescent COVID-19 Patients. The Effect of Sulodexide on Serum Levels of Biomarkers for Endothelial Dysfunction. A Pilot Prospective, Randomized, Open-label, Investigator-initiated Trial.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Serum level of soluble Thrombomodulin
研究概览
简要总结
This pilot open-label randomized controlled trial aims to assess if treatment with sulodexide may improve the endothelial status and inflammatory response in post-COVID-19 patients. Survived inpatients with severe-to-critical COVID-19 within 14 days after discharge are randomized to receive sulodexide 250 LSU 1 oral capsule twice daily or no treatment for 8 weeks. Biomarkers of endothelial dysfunction, inflammation, and prothrombotic changes are assessed at 0, 4, and 8 weeks. The hypothesis is that affected endothelial function, pro-inflammatory, and pro-thrombotic changes could be improved with sulodexide treatment in convalescent COVID-19 patients who suffered a severe-to-critical clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.
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
- Single (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
- •over 18 years old
- •male or female
- •documented PCR SARS-CoV-2 positive test
- •COVID-19 convalescence (define as at least 10 days after the onset of symptoms, no fever for at least 24 hours without the use of antipyretics and improvement of respiratory symptoms)
- •informed consent signed
- •clinical severity presentation of
- •Severe the disease is classified as severe if one of the following conditions is met:
- •Respiratory distress, respiratory rate ≥30/min Oxygen saturation on room air at rest ≤93%. Partial pressure of oxygen in arterial blood/FiO2 ≤300 mm Hg. Or
- •Critical if one of the following conditions is met. Respiratory failure and mechanical ventilation are required. Shock occurs Another organ dysfunction is present
- •risk of health complication >50% according to the health risk calculator
- •less than 14 days of hospital discharge.
排除标准
- •concomitant use of another anticoagulant
- •known pregnancy
- •known hypersensitivity to sulodexide
- •need for hospital care at screening
- •renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- •blood platelet count < 30 000/µL
- •other conditions that are judged to carry an increased risk of bleeding as judged by the Investigator
- •more than 30 days of clinical onset
研究组 & 干预措施
Sulodexide
Standard treatment plus oral sulodexide
干预措施: Sulodexide (Drug)
结局指标
主要结局
Serum level of soluble Thrombomodulin
时间窗: 8 weeks
The level of serum soluble Thrombomodulin will be measured at 0, 4, and 8 weeks by ELISA test to detect endothelial dysfunction and its improvement.
次要结局
- Serum level of Interleukine-6(8 weeks)
- Serum level of Von Willebrand factor(8 weeks)
- Serum level of VCAM-1(8 weeks)
- Serum level of ICAM-1(8 weeks)
- Serum level of soluble P-selectin(8 weeks)
- Serum level of circulating endothelial cells(8 weeks)
- Serum level of high sensitive C reactive protein(8 weeks)