Endothelial Protection in Post COVID-19 Patients With Sulodexide

NCT05371925 | Completed Phase 3 DMC

• 1 other identifier: CMN-01-2021
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Prospective, multicenter, randomized (1:1, placebo use) trial with a parallel-group design to 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. The recruitment period is estimated at 6 months. The follow-up period of all participants will be 8 weeks. The participant will receive according to group allocation after randomization

1. 1.study group: sulodexide oral dose of 250LRU capsule bid for 8 weeks.
2. 2.control group: placebo oral dose of 1 capsule bid for 8 weeks.

Conditions

Post COVID-19; Endothelial Dysfunction; Thrombosis

Keywords

Post COVID-19; sulodexide; thrombosis; thrombomodulin

Outcome Measures

Primary Outcomes (2)

• thrombomodulin

  Assess whether the use of sulodexide in convalescent COVID-19 patients affects serum thrombomodulin levels compared to placebo use.

  compare baseline level at 4 weeks of treatment

• thrombomodulin

  Assess whether the use of sulodexide in convalescent COVID-19 patients affects serum thrombomodulin levels compared to placebo use.

  compare baseline level at 8 weeks of treatment

Secondary Outcomes (10)

• P-Selectin

  compare baseline level to the ones at 4 weeks of treatment

• P-Selectin

  compare baseline level to the ones at 8 weeks of treatment

• Troponin I

  compare baseline level to the ones at 4 weeks of treatment

• Troponin I

  compare baseline level to the ones at 8 weeks of treatment

• Von Willebrand factor

  compare baseline level to the ones at 4 weeks of treatment

Other Outcomes (2)

• post-COVID-19 functional status

  compare at 4 week and 8 week of treatment

• the WHO clinical progression

  compare at 4 week and 8 week of treatment

Study Arms (2)

Sulodexide group

ACTIVE COMPARATOR

the participant will receive one Sulodexide capsule of 250LRU twice a day for 8 weeks

Drug: Sulodexide

control group

PLACEBO COMPARATOR

the participant will receive on placebo capsule twice a day for 8 weeks of same appearance as IMP

Drug: Sulodexide

Interventions

Sulodexide DRUG

one 250LRU sulodexide capsule twice a day for 8 weeks

Also known as: Vessel due F (Alfasgima SpA, Italy)

Sulodexide group; control group

Eligibility Criteria

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

You may qualify if:

• over 18 years old
• male or female
• Patients with documented PCR SARS-CoV-2 positive test obtained during the course of the disease
• 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

You may not qualify if:

• concomitant use of another anticoagulant.
• known pregnancy.
• known hypersensitivity to sulodexide
• the 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
• Elimination criteria:
• The investigator must discontinue study treatment for a given patient at any time for the following reasons:
• In case of intolerable serious adverse reactions/events, which are clinically relevant, suspected to be related to trial intervention, and affect the patient´s safety. This will be at the discretion of the investigator.

Sponsors & Collaborators

• Centro Medico del Noroeste: lead
• Alfasigma S.p.A.: collaborator

Study Sites (1)

Centro Medico del Noroeste

San Luis Río Colorado, Sonora, 83448, Mexico

Location

MeSH Terms

Conditions

Thrombosis

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alejandro J Gonzalez-Ochoa, MD

  Centro Medico del Noroeste

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: participants will be randomly distributed to received either IMP or placebo at the Research site pharmacy under the same blister format and capsule appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Prospective, multicenter, randomized (1:1, placebo use) trial with a parallel-group designed

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: June 1, 2023
• Primary Completion: February 7, 2024
• Study Completion: April 19, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)