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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulodexide | Experimental | Standard treatment plus oral sulodexide |
|
| Control | No Intervention | Standard treatment only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulodexide | Drug | Sulodexide 250 LSU 1 oral capsule twice daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of soluble Thrombomodulin | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of Von Willebrand factor | The level of serum Von Willebrand factor will be measured at 0, and 8 weeks by ELISA test to detect pro-thrombotic status, endothelial dysfunction, and their improvement. | 8 weeks |
| Serum level of ICAM-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of D-dimer | The level of serum D-dimer will be measured at 0, 4, and 8 weeks by ELISA test to detect pro-inflammatory status, pro-thrombotic changes, endothelial dysfunction, and their improvement. | 8 weeks |
| Serum level of fibrinogen |
Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirill Lobastov, PhD | Pirogov Russian National Research Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Clinical Hospital no.24 | Moscow | 127015 | Russia |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D013927 | Thrombosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C007858 | glucuronyl glucosamine glycan sulfate |
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The level of serum ICAM-1 will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement.
| 8 weeks |
| Serum level of VCAM-1 | The level of serum VCAM-1 will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement. | 8 weeks |
| Serum level of soluble P-selectin | The level of serum soluble P-selectin will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, pro-thrombotic changes, endothelial dysfunction, and their improvement. | 8 weeks |
| Serum level of circulating endothelial cells | The level of circulating endothelial cells will be measured at 0, and 8 weeks by standardized flow cytometry to detect endothelial dysfunction and its improvement | 8 weeks |
| Serum level of high sensitive C reactive protein | The level of high sensitive C reactive protein will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement. | 8 weeks |
| Serum level of Interleukine-6 | The level of serum Interleukine-6 will be measured at 0, and 8 weeks by ELISA test to detect pro-inflammatory status, endothelial dysfunction, and their improvement. | 8 weeks |
The level of serum fibrinogen will be measured at 0, 4, and 8 weeks by ELISA test to detect pro-inflammatory status, pro-thrombotic changes, endothelial dysfunction, and their improvement.
| 8 weeks |
| Platelets count in peripheral blood | Platelets count in peripheral blood will be measured at 0, 4, and 8 weeks by standard automatic analyzer for complete blood count to detect pro-inflammatory status, pro-thrombotic changes, endothelial dysfunction, and their improvement. | 8 weeks |
| Post-COVID-19 functional status | Post-COVID-19 functional status will be assessed at 0, 4, and 8 weeks by a specific questionnaire "Post-COVID-19 Functional Status (PCFS)" scale that ranges from 0 (no limitations) to 4 (severe limitations). | 8 weeks |
| Clinical progression of COVID-19 | Clinical progression of COVID-19 will be assessed at 0, 4, and 8 weeks by a specific World Health Organization Clinical progression scale that ranges from 0 (no infection) to 10 (death due to infection). | 8 weeks |
| Thrombotic complications | Venous (deep vein thrombosis, superficial vein thrombosis, pulmonary embolism) and arterial (myocardial infarction, stroke, acute limb ischemia) thrombosis will be assessed on a clinical basis and should be confirmed by appropriate imaging (duplex ultrasound scan, computed tomography scan with contrast, arterial and venous angiography). | 8 weeks |
| Major bleeding as defined by International Society on Thrombosis and Haemostasis (ISTH) criteria | Major bleeding as defined by the International Society on Thrombosis and Haemostasis (fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells) will be assessed on a clinical basis and should be confirmed by appropriate laboratory and instrumental tests. | 8 weeks |
| Clinically relevant non-major bleedingas defined by International Society on Thrombosis and Haemostasis (ISTH) criteria | Clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis (requiring medical intervention by a healthcare professional, and/or leading to hospitalization, and/or increased level of care prompting a face to face [i.e., not just a telephone or electronic communication] evaluation) will be assessed on a clinical basis and should be confirmed by appropriate laboratory and instrumental tests. | 8 weeks |
| D002318 | Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |