drugset / Trial / NCT05371925

Endothelial Protection in Post COVID-19 Patients With Sulodexide

NCT05371925

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sulodexide Other / unclassified 250 unknown Oral