Endothelial Protection in Convalescent COVID-19 Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pirogov Russian National Research Medical University
• Treatments: Glucuronyl glucosamine glycan sulfate

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