Endothelial protection in convalecent COVID-19 patients. The effect of Sulodexide on serum levels of biomarkers for endothelial dysfunction. A prospective, randomized, placebo-controlled, investigator-initiated trial.

Corporativo de Servicios Médicos Especializados S.A de C.V V (Centro Médico del Noroeste)0 sites200 target enrollmentJuly 11, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Corporativo de Servicios Médicos Especializados S.A de C.V V (Centro Médico del Noroeste)
Enrollment: 200
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

July 11, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Corporativo de Servicios Médicos Especializados S.A de C.V V (Centro Médico del Noroeste)

•\- over 18 years old
•\- male or female
•\*Candidate woman of childbearing age (18\-49 years). Animal studies do not suggest direct or indirect harmful effects in terms of reproductive toxicity, however, there is no suficient human data, so the use of some method of contraception during participation (with efficacy rate greater than 99%) will be a requirement, as well as negative pregnancy test prior to inclusion.
•\- A documented positive SARS\-CoV\-2 PCR test (only to confirm etiology of initial symptoms, given that at the time of recruitment it is expected that patients would already be in the non\-contagious stage given the time lapsed from first symptoms)
•\- 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
•Are the trial subjects under 18? no

•\- 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