Endothelial Protection in Convalescent COVID-19 Patients

NCT05252923 | Terminated Phase 4

• 1 other identifier: SDXbioCOVID-19
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Inflammation; Thrombosis; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Serum level of Von Willebrand factor

  8 weeks

• Serum level of ICAM-1

  8 weeks

• Serum level of VCAM-1

  8 weeks

• Serum level of soluble P-selectin

  8 weeks

• Serum level of circulating endothelial cells

  8 weeks

Other Outcomes (8)

• Serum level of D-dimer

  8 weeks

• Serum level of fibrinogen

  8 weeks

• Platelets count in peripheral blood

  8 weeks

Study Arms (2)

Sulodexide

EXPERIMENTAL

Standard treatment plus oral sulodexide

Drug: Sulodexide

Control

NO INTERVENTION

Standard treatment only

Interventions

Sulodexide DRUG

Sulodexide 250 LSU 1 oral capsule twice daily for 8 weeks

Sulodexide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Moscow Clinical Hospital no.24

Moscow, 127015, Russia

Location

MeSH Terms

Conditions

Inflammation; Thrombosis; COVID-19

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kirill Lobastov, PhD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: February 23, 2022
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2022
• Last Updated: June 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)