Clinical trial NCT05252923: Endothelial Protection in Convalescent COVID-19 Patients
Official title: Endothelial Protection in Convalescent COVID-19 Patients. The Effect of Sulodexide on Serum Levels of Biomarkers for Endothelial Dysfunction. A Pilot Prospective, Randomized, Open-label, Investigator-initiated Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Endothelial Dysfunction
Inflammation
Thrombosis
COVID-19
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Serum level of soluble Thrombomodulin
timeFrame: 8 weeks
Secondary outcomes:
measure: Serum level of Von Willebrand factor
timeFrame: 8 weeks
measure: Serum level of ICAM-1
timeFrame: 8 weeks
measure: Serum level of VCAM-1
timeFrame: 8 weeks
measure: Serum level of soluble P-selectin
timeFrame: 8 weeks
measure: Serum level of circulating endothelial cells
timeFrame: 8 weeks
measure: Serum level of high sensitive C reactive protein
timeFrame: 8 weeks
measure: Serum level of Interleukine-6
timeFrame: 8 weeks
Other outcomes:
measure: Serum level of D-dimer
timeFrame: 8 weeks
measure: Serum level of fibrinogen
timeFrame: 8 weeks
measure: Platelets count in peripheral blood
timeFrame: 8 weeks
measure: Post-COVID-19 functional status
timeFrame: 8 weeks
measure: Clinical progression of COVID-19
timeFrame: 8 weeks
measure: Thrombotic complications
timeFrame: 8 weeks
measure: Major bleeding as defined by International Society on Thrombosis and Haemostasis (ISTH) criteria
timeFrame: 8 weeks
measure: Clinically relevant non-major bleedingas defined by International Society on Thrombosis and Haemostasis (ISTH) criteria
timeFrame: 8 weeks
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital no.24
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Kirill Lobastov, PhD
role: PRINCIPAL_INVESTIGATOR
References: