Endothelial Protection in Post COVID-19 Patients. The Effect of Sulodexide on Serum Levels of Biomarkers for Endothelial Dysfunction. A Prospective, Randomized, Placebo-controlled, Investigator-initiated Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- thrombomodulin
研究概览
简要总结
This is a Prospective, multicenter, randomized (1:1, placebo use) trial with a parallel-group design to assess if the use of sulodexide influences serum levels of biomarkers for endothelial dysfunction on convalescent COVID-19 patients who suffered a moderate (or more severe) clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.
The recruitment period is estimated at 6 months. The follow-up period of all participants will be 8 weeks.
The participant will receive according to group allocation after randomization
- study group: sulodexide oral dose of 250LRU capsule bid for 8 weeks.
- control group: placebo oral dose of 1 capsule bid for 8 weeks.
Participants in both groups will continue the standard of care recommended by national healthcare guidelines for each Country, including any concomitant medication indicated by their primary physician.
详细描述
Background Endothelial cells play an important role in SARS-CoV-2 infection, not only as target organs but also as effectors, with several pathways possibly involved, all more widely analyzed in the acute phase. However, the exact mechanism of post-COVID-19 cardiovascular events is not fully understood nor is its involvement in perpetuating a chronic proinflammatory and prothrombotic state. Sulodexide has many useful pleitropic properties where the restoration of a proper functional endothelium should be a paramount objective to achieve when possible.
Design This is a Prospective, multicenter, randomized (1:1, placebo use) trial with a parallel-group design to assess if the use of sulodexide influences serum levels of biomarkers for endothelial dysfunction on convalescent COVID-19 patients who suffered a moderate (or more severe) clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.
The recruitment period is estimated at 6 months. The follow-up period of all participants will be 8 weeks.
The participant will receive according to group allocation after randomization
- study group: sulodexide oral dose of 250LRU capsule bid for 8 weeks.
- control group: placebo oral dose of 1 capsule bid for 8 weeks. Participants in both groups will continue the standard of care recommended by national healthcare guidelines for each Country, including any concomitant medication indicated by their primary physician.
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, Investigator)
盲法说明
participants will be randomly distributed to received either IMP or placebo at the Research site pharmacy under the same blister format and capsule appearance.
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
- •Patients with documented PCR SARS-CoV-2 positive test obtained during the course of the disease
- •Convalescent COVID-19 patient (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 according to the quick COVID-19 Severity Index (qCSI).
- •Signature of informed consent.
- •moderate or worst clinical severity presentations of COVID-
- •(According to the World Health Organization Clinical progression scale)
- •Risk of health complication >50% according to the Health risk calculator
排除标准
- •concomitant use of another anticoagulant.
- •known pregnancy.
- •known hypersensitivity to sulodexide
- •the 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
- •Elimination criteria:
- •A patient randomized in error (monitoring shows that in- or exclusion criteria have been violated) who never received the trial medication, will be excluded from all analyses
- •The investigator must discontinue study treatment for a given patient at any time for the following reasons:
- •In case of intolerable serious adverse reactions/events, which are clinically relevant, suspected to be related to trial intervention, and affect the patient´s safety. This will be at the discretion of the investigator.
研究组 & 干预措施
Sulodexide group
the participant will receive one Sulodexide capsule of 250LRU twice a day for 8 weeks
干预措施: Sulodexide (Drug)
control group
the participant will receive on placebo capsule twice a day for 8 weeks of same appearance as IMP
干预措施: Sulodexide (Drug)
结局指标
主要结局
thrombomodulin
时间窗: compare baseline level at 8 weeks of treatment
Assess whether the use of sulodexide in convalescent COVID-19 patients affects serum thrombomodulin levels compared to placebo use.
次要结局
- P-Selectin(compare baseline level to the ones at 8 weeks of treatment)
- Troponin I(compare baseline level to the ones at 8 weeks of treatment)
- Von Willebrand factor(compare baseline level to the ones at 8 weeks of treatment)
- ICAM-1(compare baseline level to the ones at 4 week and 8 week of treatment)
- VCAM-1(compare baseline level to the ones at 4 week and 8 week of treatment)
- D-dimer(compare baseline level to the ones at 4 week and 8 week of treatment)
- C reactive protein(compare baseline level to the ones at 4 week and 8 week of treatment)