Suloexide in the Treatment of Early Stages of COVID-19

NCT04483830 | Completed Phase 2 DMC

• 1 other identifier: Clidm/Vas/2020-05-01
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (5)

• hospital care

  need for hospital care admission

  21 days since start of trial participation

• days of hospital care

  number of total days in hospital care

  21 days since start of trial participation

• days of need suplemental oxigen

  total days in need of supplemental oxigen via facial mask or nasal

  21 days since the start of trial participation

• serum level of d-dimmer

  total value in ng/dl of d-dimmer

  change betwen basal level and at 14 day follow-up

• serum level of creatinine

  total value in mg/dl

  change between basal level ans at 14 day followup

Secondary Outcomes (2)

• thromboembolic event

  21 days from start of trial

• need for mechanical ventilation

  21 days from the start of the trial

Study Arms (2)

group A

PLACEBO COMPARATOR

patient with the early stages of COVID-19 to received an oral dose of placebo twice a day for 21 days

Drug: Placebo

group B

ACTIVE COMPARATOR

patient in the early stages of COVID-19 to received an oral dose of 500LRU of sulodexide twice a day for 21 days.

Drug: Sulodexide

Interventions

Sulodexide DRUG

an oral dose of 2 capsules each day for 21 days

Also known as: vessel due f

group B

Placebo DRUG

an oral dose of 2 capsules each day for 21 days

Also known as: vessel due f -placebo

group A

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinedem: lead
• Alfasigma S.p.A.: collaborator

Study Sites (1)

Clinedem

San Luis Río Colorado, Sonora, 83449, Mexico

Location

Related Publications (1)

• Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

  PMID: 35244208 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alejandro j Gonzalez-Ochoa, md

  Clinedem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: placebo control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular and endovascular surgery

Model Details: prospective, single centre, randomized, placebo-control trial

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 23, 2020
• Study Start: June 5, 2020
• Primary Completion: August 6, 2020
• Study Completion: September 7, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)