Sulodexide in the treatment of patients with early stages of COVID-19: a randomized controlled trial.

Background Sulodexide has pleiotropic properties within the vascular endothelium that can prove beneficial for the treatment of patients with COVID-19. We aimed to evaluate the effect of sulodexide when used in the early clinical stages of COVID-19. Methods In an outpatient setting, we conducted a randomized controlled trial with a parallel-group design. Including patients within three days of clinical onset, who were at a high risk of severe clinical progression due to chronic comorbidities. Participants were randomly assigned to receive an oral dose of sulodexide (500 LRU twice a day) or placebo for 21 days. Primary outcomes were need-length of hospitalization and need-length of oxygen support. Results Between June 5 and August 30, 2020, 243 patients were included in the per-protocol analysis. 124 of them received sulodexide, while 119 received placeboes. At 21 days follow-up, 17.7% patients required hospitalization in the sulodexide group compared to 29.4% in the placebo group, p=0.03. 29.8% required oxygen support in the sulodexide group vs 42% in the placebo group, p=0.05 and for fewer days [9 (7.2 SD) in the sulodexide group vs. 11.5 (9.6 SD) in the placebo group; p=0.02]. There was no between-group difference concerning the length of hospital stay. Interpretation Early intervention in COVID-19 patients with sulodexide reduced hospital admissions and oxygen support requirements. This has beneficial implications in the patient's well-being, making sulodexide a favorable medication until an effective vaccine or an antiviral becomes available. Funding Researcher independently initiated, partially funded by Alfasigma, Mexico. ISRCTN registry listed under ID ISRCTN59048638.