Endothelial Protection in Convalescent COVID-19 Patients

Phase 4TerminatedNCT05252923

Pirogov Russian National Research Medical University2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Endothelial Dysfunction Inflammation Thrombosis COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

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

Time frame: 8 weeks

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

Endothelial Protection in Convalescent COVID-19 Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes