Endothelial Protection in Convalescent COVID-19 Patients

Pirogov Russian National Research Medical University

Status and phase

Terminated

Phase 4

Conditions

COVID-19

Inflammation

Endothelial Dysfunction

Thrombosis

Treatments

Drug: Sulodexide

Study type

Interventional

Funder types

Other

Identifiers

NCT05252923

SDXbioCOVID-19

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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