Status:
COMPLETED
Endothelial Protection in Post COVID-19 Patients With Sulodexide
Lead Sponsor:
Centro Medico del Noroeste
Collaborating Sponsors:
Alfasigma S.p.A.
Conditions:
Post COVID-19
Endothelial Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Prospective, multicenter, randomized (1:1, placebo use) trial with a parallel-group design to assess if the use of sulodexide influences serum levels of biomarkers for endothelial dysfunctio...
Detailed Description
Background Endothelial cells play an important role in SARS-CoV-2 infection, not only as target organs but also as effectors, with several pathways possibly involved, all more widely analyzed in the a...
Eligibility Criteria
Inclusion
- over 18 years old
- male or female
- Patients with documented PCR SARS-CoV-2 positive test obtained during the course of the disease
- Convalescent COVID-19 patient (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 according to the quick COVID-19 Severity Index (qCSI).
- Signature of informed consent.
- moderate or worst clinical severity presentations of COVID-19. (According to the World Health Organization Clinical progression scale)
- Risk of health complication \>50% according to the Health risk calculator
Exclusion
- concomitant use of another anticoagulant.
- known pregnancy.
- known hypersensitivity to sulodexide
- the 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
- Elimination criteria:
- A patient randomized in error (monitoring shows that in- or exclusion criteria have been violated) who never received the trial medication, will be excluded from all analyses
- The investigator must discontinue study treatment for a given patient at any time for the following reasons:
- • In case of intolerable serious adverse reactions/events, which are clinically relevant, suspected to be related to trial intervention, and affect the patient´s safety. This will be at the discretion of the investigator.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT05371925
Start Date
June 1 2023
End Date
April 19 2024
Last Update
August 9 2024
Active Locations (1)
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1
Centro Medico del Noroeste
San Luis Río Colorado, Sonora, Mexico, 83448