Endothelial Protection in Post COVID-19 Patients With Sulodexide

• Status: Not yet recruiting
• Trial end date: 2022-11-12
• Target enrollment: 0
• Participant gender: All

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 dysfunction on convalescent COVID-19 patients who suffered a moderate (or more severe) clinical presentation and have chronic comorbidities of high risk for endothelial dysfunction.

The recruitment period is estimated at 6 months. The follow-up period of all participants will be 8 weeks.

The participant will receive according to group allocation after randomization

1. study group: sulodexide oral dose of 250LRU capsule bid for 8 weeks.

2. control group: placebo oral dose of 1 capsule bid for 8 weeks.

Participants in both groups will continue the standard of care recommended by national healthcare guidelines for each Country, including any concomitant medication indicated by their primary physician.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Medico del Noroeste
• Collaborator: Alfasigma S.p.A.
• Treatments: Glucuronyl glucosamine glycan sulfate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.