Endothelial Protection in Convalescent COVID-19 Patients

NCT ID: NCT05252923

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sulodexide

Standard treatment plus oral sulodexide

Group Type: EXPERIMENTAL

Sulodexide

Intervention Type: DRUG

Sulodexide 250 LSU 1 oral capsule twice daily for 8 weeks

Control

Standard treatment only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sulodexide

Sulodexide 250 LSU 1 oral capsule twice daily for 8 weeks

Intervention Type: DRUG

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

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

2. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirill Lobastov, PhD

Role: PRINCIPAL_INVESTIGATOR

Pirogov Russian National Research Medical University

Locations

Moscow Clinical Hospital no.24

Moscow, , Russia

Countries

Russia

Other Identifiers

SDXbioCOVID-19

Identifier Type: -

Identifier Source: org_study_id