Back to resultsEndothelial Protection in Convalescent COVID-19 Patients
Primary Purpose
Endothelial Dysfunction, Inflammation, Thrombosis
Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Sulodexide
Sponsored by
About this trial
This is an interventional treatment trial for Endothelial Dysfunction
Eligibility Criteria
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:
- 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
Sites / Locations
- Moscow Clinical Hospital no.24Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sulodexide
Control
Arm Description
Standard treatment plus oral sulodexide
Standard treatment only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Serum level of ICAM-1
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.
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.
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.
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
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.
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.
Full Information
NCT ID
NCT05252923
First Posted
February 21, 2022
Last Updated
April 21, 2022
Sponsor
Pirogov Russian National Research Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05252923
Brief Title
Endothelial Protection in Convalescent COVID-19 Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pirogov Russian National Research Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Inflammation, Thrombosis, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sulodexide
Arm Type
Experimental
Arm Description
Standard treatment plus oral sulodexide
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment only
Intervention Type
Drug
Intervention Name(s)
Sulodexide
Intervention Description
Sulodexide 250 LSU 1 oral capsule twice daily for 8 weeks
Primary Outcome Measure Information:
Title
Serum level of soluble Thrombomodulin
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Serum level of Von Willebrand factor
Description
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.
Time Frame
8 weeks
Title
Serum level of ICAM-1
Description
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.
Time Frame
8 weeks
Title
Serum level of VCAM-1
Description
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.
Time Frame
8 weeks
Title
Serum level of soluble P-selectin
Description
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.
Time Frame
8 weeks
Title
Serum level of circulating endothelial cells
Description
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
Time Frame
8 weeks
Title
Serum level of high sensitive C reactive protein
Description
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.
Time Frame
8 weeks
Title
Serum level of Interleukine-6
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Serum level of D-dimer
Description
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.
Time Frame
8 weeks
Title
Serum level of fibrinogen
Description
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.
Time Frame
8 weeks
Title
Platelets count in peripheral blood
Description
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.
Time Frame
8 weeks
Title
Post-COVID-19 functional status
Description
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).
Time Frame
8 weeks
Title
Clinical progression of COVID-19
Description
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).
Time Frame
8 weeks
Title
Thrombotic complications
Description
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).
Time Frame
8 weeks
Title
Major bleeding as defined by International Society on Thrombosis and Haemostasis (ISTH) criteria
Description
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.
Time Frame
8 weeks
Title
Clinically relevant non-major bleedingas defined by International Society on Thrombosis and Haemostasis (ISTH) criteria
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirill Lobastov, PhD
Phone
+79852116331
Email
lobastov_kv@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirill Lobastov, PhD
Organizational Affiliation
Pirogov Russian National Research Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moscow Clinical Hospital no.24
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirill Lobastov, PhD
Phone
+7-985-211-63-31
Email
lobastov_kv@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Endothelial Protection in Convalescent COVID-19 Patients
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