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Endothelial Protection in Post COVID-19 Patients With Sulodexide

NCT05371925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2024-08-09

No results posted yet for this study

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

Participants in both groups will continue the standard of care recommended by national healthcare guidelines for each Country, including any concomitant medication indicated by their primary physician.

Conditions

  • Post COVID-19
  • Endothelial Dysfunction
  • Thrombosis

Interventions

DRUG

Sulodexide

one 250LRU sulodexide capsule twice a day for 8 weeks

Sponsors & Collaborators

  • Alfasigma S.p.A.

    collaborator INDUSTRY

  • Centro Medico del Noroeste

    lead OTHER

Principal Investigators

  • Alejandro J Gonzalez-Ochoa, MD · Centro Medico del Noroeste

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-02-07
Completion
2024-04-19

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05371925 on ClinicalTrials.gov