Endothelial Protection in Convalescent COVID-19 Patients

Sponsor
Pirogov Russian National Research Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05252923
Collaborator
(none)
30
1
2
9
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sulodexide

Standard treatment plus oral sulodexide

Drug: Sulodexide
Sulodexide 250 LSU 1 oral capsule twice daily for 8 weeks

No Intervention: Control

Standard treatment only

Outcome Measures

Primary Outcome Measures

  1. Serum level of soluble Thrombomodulin [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.

Secondary Outcome Measures

  1. Serum level of Von Willebrand factor [8 weeks]

    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.

  2. Serum level of ICAM-1 [8 weeks]

    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.

  3. Serum level of VCAM-1 [8 weeks]

    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.

  4. Serum level of soluble P-selectin [8 weeks]

    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.

  5. Serum level of circulating endothelial cells [8 weeks]

    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

  6. Serum level of high sensitive C reactive protein [8 weeks]

    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.

  7. Serum level of Interleukine-6 [8 weeks]

    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.

Other Outcome Measures

  1. Serum level of D-dimer [8 weeks]

    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.

  2. Serum level of fibrinogen [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.

  3. Platelets count in peripheral blood [8 weeks]

    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.

  4. Post-COVID-19 functional status [8 weeks]

    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).

  5. Clinical progression of COVID-19 [8 weeks]

    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).

  6. Thrombotic complications [8 weeks]

    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).

  7. Major bleeding as defined by International Society on Thrombosis and Haemostasis (ISTH) criteria [8 weeks]

    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. Clinically relevant non-major bleedingas defined by International Society on Thrombosis and Haemostasis (ISTH) criteria [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moscow Clinical Hospital no.24 Moscow Russian Federation 127015

Sponsors and Collaborators

  • Pirogov Russian National Research Medical University

Investigators

  • Principal Investigator: Kirill Lobastov, PhD, Pirogov Russian National Research Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pirogov Russian National Research Medical University
ClinicalTrials.gov Identifier:
NCT05252923
Other Study ID Numbers:
  • SDXbioCOVID-19
First Posted:
Feb 23, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022