Suloexide in the Treatment of Early Stages of COVID-19

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

Conditions

• Covid19

Interventions

DRUG

Sulodexide

an oral dose of 2 capsules each day for 21 days

DRUG

Placebo

an oral dose of 2 capsules each day for 21 days

Sponsors & Collaborators

• Alfasigma S.p.A.

  collaborator INDUSTRY

• Clinedem

  lead OTHER

Principal Investigators

• Alejandro j Gonzalez-Ochoa, md · Clinedem

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-05

Primary Completion

2020-08-06

Completion

2020-09-07

Countries

• Mexico

Study Locations