A prospective, randomised, placebo-controlled, investigator-initiated study of the effect of Sulodexide on endothelial protection in convalescent COVID-19 patients.
- Conditions
- 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.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2022-001958-36-HU
- Lead Sponsor
- Corporativo de Servicios Médicos Especializados S.A de C.V V (Centro Médico del Noroeste)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method