Status:
TERMINATED
Endothelial Protection in Convalescent COVID-19 Patients
Lead Sponsor:
Pirogov Russian National Research Medical University
Conditions:
Endothelial Dysfunction
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 inpatient...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05252923
Start Date
April 1 2022
End Date
December 31 2022
Last Update
June 13 2025
Active Locations (1)
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1
Moscow Clinical Hospital no.24
Moscow, Russia, 127015