Sulodexide in the Treatment of Early Stages of COVID-19
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 243
- Locations
- 1
- Primary Endpoint
- days of need suplemental oxigen
Study Overview
Brief Summary
Problem:
The COVID- 19 pandemic has not only affected our healthcare system, but the impact on the worldwide financial systems and our "normal" way of life is still to be determined.
Although the percentage of patients infected with COVID-19 that need hospital care is low, Its high rate of contagiousness makes the total number of patients in need of hospital care cripple any healthcare system, limiting the space available for other patients in need of critical care, who cannot be admitted or even prefer not to attend the hospital in fear of infection.
Early investigations report an Increase risk of thromboembolic complications, and a systemic inflammatory response not clearly understood. There is a possible vascular endothelial dysfunction due to chronic comorbidities (Hypertension, diabetes, obesity, chronic kidney disease, lung disease) as a risk factor for a more severe presentation.
Justification:
Sulodexide is a two-compound drug, each of them with different endothelial action that can be beneficial in COVID-19 patients.
Glycosaminoglycans: Can help restore venous and arterial endothelial glycocalyx which can downregulate or limit the response to inflammatory molecules, by maintaining the integrity lost in certain chronic diseases (high blood pressure, diabetes).
Heparin compound: It has an antithrombotic effect that could help reduce the incidence of thromboembolic complications, and also add to the anti-inflammatory response due to it anti-thrombin action (similar or a bit less to that of low molecular weight heparin) with less risk of major bleeding.
It's a medication that can be used orally with minimal adverse effects and is less expensive than low molecular weight heparin.
Hypothesis:
We hypothesize that sulodexide instituted early in populations at significant risk and symptomatic patients affected with COVID-19 (shortness of breath, fever, weakness, diarrhoea) and risk factors of diabetes, hypertension, COPD, atherosclerosis, chronic kidney disease, will provide improvement in endothelial integrity, decrease inflammatory responses, and improved clinical outcomes with decreased hospital admission, decrease VTE and arterial complications, morbidity, and mortality.
Objective:
To use sulodexide in patients that have early onset of COVID-19 symptoms to mitigate the progression of the disease process that can allow them to recover at home, and limit the need of hospital care and a more severe clinical manifestation
Detailed Description
Objective:
To use sulodexide in patients that have early onset of COVID-19 symptoms to mitigate the progression of the disease process that can allow them to recover at home, and limit the need for hospital care and the more severe manifestation which includes fulminant respiratory failure, acute kidney injury, cardiomyopathy, and thrombosis.
Target study population:
COVID-19 positives in the early but symptomatic stages of the disease (fever, cough, shortness of breath, malaise, diarrhoea, nausea, vomiting, anosmia). High risk of developing a severe presentation of the disease (due to chronic comorbidities).
Research methodology Prospectively, information collection will be carried out in COVID-19 patients, who are in early stages of the disease, defined as a beginning of symptoms of 3 days or less, who attend the CLINEDEM medical unit, located in San Luis Rio Colorado, Sonora, Mexico, in the period from June 15, 2020, to 30 August 2020. Demographic and clinical data will be collected digitally and physically and kept in the clinical record individually the researcher.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
placebo control
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •3 days or less with clinical COVID-19 symptoms (fever, cough, sour throat, headache, body ache, anosmia, diarrhoea, vomiting).
- •sign inform consent.
- •>50% risk developing a severe clinical presentation of COVID-19 according to risk calculator
Exclusion Criteria
- •COVID-19 negative test
- •known pregnancy
- •chronic use of steroid medication
- •deep vein thrombosis in the last 6 months
- •extended anticoagulation in the last 3 months.
- •known allergy to sulodexide.
- •severe symptoms that warrant hospital care at initial screening
Arms & Interventions
group A
patient with the early stages of COVID-19 to received an oral dose of placebo twice a day for 21 days
Intervention: Placebo (Drug)
group B
patient in the early stages of COVID-19 to received an oral dose of 500LRU of sulodexide twice a day for 21 days.
Intervention: Sulodexide (Drug)
Outcomes
Primary Outcomes
days of need suplemental oxigen
Time Frame: 21 days since the start of trial participation
total days in need of supplemental oxigen via facial mask or nasal
serum level of d-dimmer
Time Frame: change betwen basal level and at 14 day follow-up
total value in ng/dl of d-dimmer
days of hospital care
Time Frame: 21 days since start of trial participation
number of total days in hospital care
hospital care
Time Frame: 21 days since start of trial participation
need for hospital care admission
serum level of creatinine
Time Frame: change between basal level ans at 14 day followup
total value in mg/dl
Secondary Outcomes
- need for mechanical ventilation(21 days from the start of the trial)
- thromboembolic event(21 days from start of trial)
Investigators
alejandro jose gonzalez ochoa
Vascular and endovascular surgery
Clinedem