Endothelial Protection in Convalescent COVID-19 Patients

Phase 4

• Conditions: COVID-19; Endothelial Dysfunction; Inflammation; Thrombosis
• Interventions: Drug: Sulodexide

• Registration Number: NCT05252923
• Lead Sponsor: Pirogov Russian National Research Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-02-23
• Study Start: 2022-04-01
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulodexide	Sulodexide	Standard treatment plus oral sulodexide

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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.
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
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.

Trial Locations

Locations (1)

Moscow Clinical Hospital no.24; 🇷🇺 Moscow, Russian Federation