Coronavirus disease 2019 (COVID-19) is an infectious disease caused by coronavirus 2 (SARS-CoV-2) and, thus, being a novel cause of sepsis and the the poor outcome of patients with sepsis was related to systemic microvascular endothelial dysfunction in the vital organs of the body.
Conditions
Interventions
Trade Name: Vessel due F
Product Name: Vessel due F
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
Corporativo de Servicios Médicos Especializados S.A de C.V V (Centro Médico del Noroeste)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: NA;Primary end point(s): -Assess whether the use of sulodexide in convalescent COVID-19 patients affects serum thrombomodulin levels compared to placebo use. Evaluated at week 4 and week 8.;Timepoint(s) of evaluation of this end point: after 8 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluate whether the use of sulodexide in convalescent COVID-19 patients affects serum levels of endothelial inflammatory activation biomarkers compared to placebo use. Evaluated at week 4 and week 8. - Evaluate whether the use of sulodexide in convalescent COVID-19 patients affects serum levels of thrombogenic biomarkers compared to placebo use. Assessed at week 4 and week 8 ;Timepoint(s) of evaluation of this end point: after 8 weeks | — |
Countries
Hungary, Mexico, Russian Federation, United States
Contacts
Public ContactJudit Néma
AdWare Research Kft.
Outcome results
None listed